Careers

Must bring at least 1 year of process engineering experience in an FDA regulated manufacturing facility, preferably in bulk liquid processing, aseptic processing, and CIP operations in the food/pharma/nutrition industries.

What You’ll Do

As a process engineer, you will:
As a process engineer, you will:

• Provide technical leadership on design, development, implementation, optimization, and validation of processing equipment.
• Lead the technical execution of multiple concurrent medium- to large-size capital projects for client nutrition plants in the North America region.
• Work to develop provisional scope, design, manufacturability, cost, capital, risk and schedule considerations while collaborating with cross-functional teams.
• Develop, modify, and evaluate Process Flow Diagrams, P&IDs, Mass/Energy balance sheets and other engineering and design documents with respect to accuracy, precision, and reliability.
• Review equipment and instrument specifications, construction drawings, plant layout, plant 3D model, vendor proposals and provide feedback on needed changes.
• Provide technical support to North America client plants, including existing system issues as well as design improvements/new designs as part of continuous improvement, and act as a technical influencer to senior leadership and stakeholders for business initiatives.
• 30% travel is expected as part of the role.

Education and Experience You’ll Bring:

• A Bachelor’s Degree in Engineering (Preferably Chemical or Mechanical engineering).
• 2+ years’ experience, applying engineering knowledge, problem solving, and ingenuity to complete assignments related to process/manufacturing systems.
• Familiarity with bulk liquid processing, aseptic processing, CIP, evaporation, spray drying, dry blending, and powder handling unit operations in the food/pharma/nutrition industries.
• Experience in managing engineering firms, suppliers, and contractors.
• Exposure to validated processes and systems.
• Experience in project management including budget and scope management.
• Systems troubleshooting and Root Cause Analysis experience.
• Strong communication skills including managing internal/external stakeholders

Send resume to and refer to job title to careers@vsgmgroup.com

Location: Remote role

August start date – till end of year with potential to be 2 year contract for the right person

Need to be primary Automation Engineers with CSV knowledge as a secondary (Despite how the JD reads!)

Fully remote


We are seeking a highly skilled and detail-oriented CSV & Integration Specialist to join our team on a contract basis. The primary responsibilities of this role include authoring CSV documents for the mAlert program, building program governance around CSV document approvals, and troubleshooting and configuring integrations between various systems.


The ideal candidate will have a strong background in data management, system integration, and experience with Emerson DeltaV and Syncade.


Key Responsibilities:

• Author and maintain CSV documents for the mAlert program. • Build and implement program governance around CSV document approvals.
• Drive document approvals with relevant stakeholders.
• Troubleshoot and configure integrations between ODH, DeltaV, Syncade, and other systems that provide data to the mAlert platform.
• Ensure data accuracy and integrity within all CSV files.
• Collaborate with team members and stakeholders to gather necessary data and information for CSV documentation.
• Adhere to company standards and protocols for data management, documentation, and system integration.
• Provide regular updates and reports on the status of CSV documentation tasks and system integrations.

Qualifications:

• Proven experience in authoring and managing CSV documents.
• Strong understanding of JSON payloads and data architectures.
• Experience with Emerson DeltaV and Emerson Syncade.
• Knowledge of GMP (Good Manufacturing Practice) regulations.
• Understanding of remote alarm notification and alarm review processes. • Excellent troubleshooting and problem-solving skills.
• Strong attention to detail and accuracy.
• Proficiency in data management and data entry.
• Experience with data analysis and data visualization tools.
• Knowledge of programming languages such as Python or R for data manipulation.
• Understanding of database management systems.

Send resume to and refer to job title to careers@vsgmgroup.com

THIS IS A 3 MONTH CONTRACT TO HIRE FTE POSITION

Pay: 60.00/hr.

Shift: Mon-Fri, 8:00am-5:00pm.

MUST HAVE – GENE/CELL THERAPY MANUFACTURING EXP.

• The MS&T Specialist provides technical support to Princeton, NJ Facility.
• Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process.
• The MS&T Specialist works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions.
• Other responsibilities include participation in process tech transfer and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site.
• The MS&T Specialist works to identify and drive continuous improvements to the manufacturing process.
• Functions as a technology and process subject matter expert.
• Provides on-the-floor and on-site technical support to manufacturing when necessary.
• Author, and approve protocol and reports in accordance with internal and external regulatory expectations (Client, Engineering, Tech Transfer).
• Lead and executes CAPA system investigations.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus.

Send resume to and refer to job title to careers@vsgmgroup.com

Brief Job Description:


On-site/hybrid in Irvine, CA preferred – open to remote candidate if they are a perfect fit


SUMMARY DESCRIPTION

This is a key functional role within the Design and Reliability Assurance Engineering team. The role involves the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams. This role is responsible to also lead and coordinate process, practice, procedures and technology adoption for the continuous improvement of risk management work product and deliverables for projects and programs.


The role is also responsible for support of New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity. This individual will collaborate with internal customers and external design and development partners, participating on cross-functional project teams through all phases of the product and process development through commercialization, and support technical teams with planning, execution, reporting and communication of Design and Reliability Assurance work products and deliverables.


ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Provide risk management leadership, expertise, guidance and supervision during all project phases from initiation through end of life.
• Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.
• Leads development and implementation of key performance indicators (KPI’s) and metrics for the risk management process and metrics.
• Leads and conducts SWAT assessments in risk management to support continuous improvement across business processes.
• Lead the process of planning, organizing, leading and reporting all risk management activities through collaboration with cross functional teams.
• Lead and support New Product Development (NPD), Sustaining Engineering and Continuous Improvement projects of varying scope and complexity in compliance to ISO 14971 (2019) and IEC 62366 (2015)

QUALIFICATIONS/EXPERIENCE REQUIRED

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s Degree in Engineering (Mechanical, Systems, Chemical or Electrical) or Science (Mathematic, Chemistry).
• 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971) to Class II and Class III medical devices.
• Expertise in the application of Statistical Techniques to support Design of Experiments, Design Verification and Design Valiation.
• Expertise in DFSS techniques (Design Optimization and Characterization)
• Expertise in industry best practices and advances in Risk Management practices, process, tools and technology

Thanks in advance for your time and consideration, please feel free to provide a current version of your resume. I look forward to hearing from you.

Send resume to and refer to job title to careers@vsgmgroup.com

Must have CSV QA/quality experience; the ideal candidate will have performed the final QA signature on the entire SDLC documentation suite.

• Delta V experience.
• Strong Data Integrity knowledge; knowledge of principles, how to apply them, and how to improve and implement data integrity.

Responsibilities include the following:

Review all IT CSV project and system deliverables including but not limited to:

• Plans
• Requirements
• Specifications
• Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc.)
• Summary Reports
• Change Controls
  • Review system operational and administration procedures to ensure they are adequate
  • Document any findings of non-compliance
  • Assist with strategy regarding remediation activities
  • Assist with review of remediation activities

Send resume to and refer to job title to careers@vsgmgroup.com

We need a person to have a implementation experience of primarily on DMS and APQP (preferably from the supplier ETQ).


Business Systems Analyst, DMS and APQP
The Analyst is responsible for implementing an APQP Application along with a Document management system application. Also will be responsible for integration with SAP.

Qualifications

• Should have executed at least one end to end implementation of APQP and DMS Module.
• AIAG core tools knowledge (APQP, PPAP, FMEA, CAPA etc.)
• Knowledge of SAP and its master data
• Strong proven experience with IT Delivery type projects, significant experience with solution implementation/integration projects
• Ability to write business and system requirements documents that convey complex analysis and solutions clearly and concisely.
• Ability to lead meetings with clients to define goals, pain points, project scope, timeline, requirements, technical requirements, data needs, and workflows.
• Bachelor’s Degree or 5-10 years experience in Quality Management/DMS
• In-depth knowledge of Quality guidelines and recommendations as well as the specific requirements of automotive OEMs and manufacturers
• Implementation Experience in any products from ETQ would be an added advantage.

Responsibilities

• Architect, Design and Implement DMS and APQP Modules.
• Architect and manage SAP integration projects. And Write Functional Spec Docs including the data mapping.
• Work with developers and test system and troubleshoot issues.
• Conduct User testings, Training programs.

Send resume to and refer to job title to careers@vsgmgroup.com

The CAPA Process Analyst II:

• Years Experience: 4+ Years.
• Progresses investigations and other activities through the CAPA program.
• Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.
• Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.
• Leads a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the client Code of Conduct.

Main Responsibilities:

• Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformances, potential nonconformances, CAPAs, deviations, and/or complaint investigations.
• Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required.
• Provides leadership for the initiation of improvement activities associated with identified trends.
• Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
• Ensures effective written and verbal communications.
• Prioritizes workload in relation to the needs of the business.
• Supports the attainment of client Toxicology Laboratories goals and objectives.
• Ensures compliance to organizational procedure, regulatory requirements and industry standards and timely completion of CAPAs and audit findings.

Required Qualifications:

• Bachelor’s degree in engineering or Life Sciences
• Experience with Corrective and Preventative Action process in medical devices or laboratories
• Excellent communication and technical writing skills

Preferred Qualifications:

• Understanding of statistics, FMEA and a ASQ CQE
• Knowledge of Quality requirements within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) regulations or similar regulated industry.

Send resume to and refer to job title to careers@vsgmgroup.com

The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings, and read and interpret blueprints.


Job Responsibilities:

• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
  Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.

Send resume to and refer to job title to careers@vsgmgroup.com

Job Description
HM’s Top Needs:
Design controls
Process validation
Risk Management
Statistics
Test Method Validation


Years’ Experience Required: Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Engineering.

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes
Work Location: Northridge
Do they need to be local to any MDT office and if so where? Yes, Northridge.
Does this person need to be on site? If so, full time or part time? Yes.

Participating in complex medical device product development per the FDA design controls starting from design planning through design transfer by demonstrating a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to product development.

• Collaborate with cross-functional teams and apply a systems mindset to develop and evaluate designs from a design input requirements / design outputs perspective that span across multiple product interfaces.
• Drive risk management deliverables by facilitating and generating design and process failure modes effects analysis (DFMEA/SWFMEA/PFMEA) and Hazard Analysis and experienced in facilitation / execution of the process or design/software FMEAs.
• Utilize the risk management and robust design principles to develop and identify essential design outputs / critical to quality (CTQ) attributes by partnering with appropriate design team members in early design and development.
• Design Verification/Validation and Reliability demonstration – Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies. Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record.
• Collaborating with the various product development teams like R&D, Ops, Design / Supplier quality, risk management etc. to ensure work products comply with Client procedures, acceptable qualitative and quantitative criteria, and global standards and regulations.
• Collaborating with Ops in reviewing and approving Assembly Procedures, Travelers, and Work-Orders.
• Generating master validation plans/reports and design transfer activities as applicable.
• Partner with cross-functional teams in performing Process Qualification activities.
• Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities (PPAP activities).
• Effectively navigates & facilitates project teams with respect to internal processes and procedures ensuring the delivery of safe and effective products.
• Driving clarity and consistency in documentation.
• Review and Close out Non-Conformances (Company) as they occur.
• Leading CAPA projects and assisting post market analysis.
• Participating in support of external and internal regulatory audits and inspections.
• Driving Process improvement activities.
• Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.
• Performs other related duties as assigned.

Send resume to and refer to job title to careers@vsgmgroup.com

Summary:

• The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards.
• A typical quality engineer can read and interpret blueprints and evaluate product integrity and standards.

Job Responsibilities:

• Review and approve sampling procedures and designs, forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Review and supervise programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
• May conduct training sessions on quality control activities.
• Considered a specialist in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.
• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability.
• Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, materials, and products.
• Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as chemical, electrical, or mechanical.

Skills:

• Creativity, verbal and written communication skills, analytical and problem-solving ability.
• Team player and detail oriented.
• Strong leadership and mentoring skills necessary to provide support and constructive performance feedback.
• Strong ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Education/Experience:

• Bachelor’s degree in engineering required.
• 8-10 years’ experience required.
• Able to facilitate small team in the 8D problem solving process.
• Good Communication Skill

Send resume to and refer to job title to careers@vsgmgroup.com

General Requirement & Expectation:

• Minimum 10 plus years of PeopleSoft FSCM 9.2 – General Ledger, AR, AP, Billing, Purchasing, Inventory, Cost Management
• Resource should have PeopleSoft technical expertise around-50%.
• PeopleSoft Functional expertise around -50%.
• Good Communication, Problem solving and Analytical skills.
• Should be able to lead technical troubleshooting and manage Service Now tickets.
• Troubleshoot and fix reported bugs and issues.
• Test and remediate (as needed) all development and bug/issue fixes.
• Document solutions and system information.
• Migrate and validate code changes.
• All People tools related knowledge
• Accounts Payable
• Receivable / Billing
• Order Management
• Inventory / Cost Management / Purchasing
• Perform conference room pilot to confirm configuration and processing for client to validate business processes are functioning as expected.
• Aid in unit testing of development.
• Establish configuration workbook.
• Support client to create test scenarios and scripts.
• Support client test cycles with issue resolution and configuration updates.
• Provide input into any training materials.
• Ensure end-to-end business processes function with new multi-currency and multi-company functionality enabled.

Skills & Experience you MUST have to get hired:

• 15 + yrs. of experience with PeopleSoft PeopleTools development.
• 10 + yrs. of PeopleSoft FSCM Business Process involving Procure to Pay and Order to Cash process + Inventory.
• 10 + yrs. of experience using SQL with an Oracle database.
• 10 yrs. of experience PeopleSoft PeopleCode
• 10+ yrs. of experience of doing in-depth data analysis.
• 10+ yrs. of experience with PeopleSoft Application Engine programming.
• 3 yr. of experience with PeopleSoft XML Publisher.
• 10+yr. of experience conducting design review meetings and documenting meetings.

Send resume to and refer to job title to careers@vsgmgroup.com

Initially Remote (New Jersey)

• The candidate is responsible for handling all the software development related processes.
• Analyse requirements and propose software solutions to solve problems.
• Write well- structured and testable code following the set guidelines.
• Provide operational support for software development.
• Perform occasional evaluation of new technologies and methodologies for use within the projects to be developed.
• Must have good analytical and problem- solving skills.
• Abides by all Company policies and procedures.

Job Requirements:

• 10-12 years of experience in Web application software development
• Hands- on experience in VB.Net
• Hands- on experience in SQL Server
• Exposure to Object- Oriented design is an added advantage.
• Integrate and validate new product designs.
• Excellent verbal, written and interpersonal skills.
• Excellent Analytical and Problem-Solving Skills.
• Thoroughness and attention to detail.
• The ability to work both in a team and alone and to manage your own workload.
• An ability to learn new skills and technologies quickly.
• An awareness of current issues affecting the industry and its technologies.

Send resume to and refer to job title to careers@vsgmgroup.com

Need 12+ year experience candidate


Our Company, the global business and financial information and news leader, gives influential decision makers a critical edge by connecting them to a dynamic network of information, people and ideas. The company’s strength – delivering data, news and analytics through innovative technology, quickly and accurately – is at the core of the Company’s Professional service, which provides real time financial information to more than 345,000 subscribers globally. Our enterprise solutions build on the company’s core strength, leveraging technology to allow customers to access, integrate, distribute and manage data and information across organizations more efficiently and effectively. Through our Company Law, Company’s Government, Company’s New Energy Finance and Company’s BNA, the company provides data, news and analytics to decision makers in industries beyond finance.


The Role:


We are seeking an experienced Senior Python/Javascript Developer to assist our team in delivering critical features for an internal applications used across the company. We are looking for someone who can collaboratively work with our team in their efforts. This is a contract position.


What we do:
We build and manage a suite of products using a combination of third party cloud software and in house technologies to scale to meet the demands of global employees & the philanthropy administrative teams. Our goal is to improve the velocity of operations and admin teams by enhancing the self-service tools and giving them more control. We value high quality user experience while being passionate about DevX and working in a fast-paced, dynamic environment collaborating with exceptional people.


We’ll trust you to:

• Leverage your technical expertise to implement critical solutions
• Work collaboratively within the team and across functional areas to drive design and implementation of new product features, from inception through to production

You’ll need to have:

• 4+ years of coding experience in Python, JavaScript
• Experience with SQL Server and/or PostgreSQL databases
• Strong communication skills
• Passion for solving problems for end users
• A Degree in Computer Science, Engineering, Mathematics, similar field of study or equivalent work experience

We’d love to see:

• Experience in designing and building successful customer facing applications
• Experience in ReactJS
• Familiarity with GraphQL, Redis and Kafka
• Familiarity with Agile methodologies like Scrum and Kanban, using Jira

Send resume to and refer to job title to careers@vsgmgroup.com

.NET Team Lead JD:

• Deep knowledge and understanding of .NET Core Framework.
• Strong development, debugging and troubleshooting skill on C#, .Net Core Web API, backend.
• Strong Conceptual understanding of Azure Cloud and understanding PaaS based services and solution.
• Experience with Angular and Entity Framework must to have.
• Strong knowledge and understanding of Object-Oriented Design Patterns and Principles.
• Experience on ADO CI/ CD pipelines.
• Ability to solve complex business problem through logical and creative thinking.
• Great aptitude to synthesize complex information.
• Strong written and verbal communication skills.
• Strong track record as a hands-on engineer designing and delivering elegant solutions to meet complex design and architectural challenges in a cloud services environment.
• Provides technical guidance to Members of the Team
• May coordinate the daily activities of a team. Assigns tasks, set priorities. Serves as first point of contact to individual contributors before escalting to management.
• Help lead in the design and development of cross-functional, multi-platform application systems.
• Write great quality code with a drive for automated testing and validation based on the You Build You Own (YBYO) model.
• Perform complex engineering activities for performance tuning, monitoring, deployment and production support.
• Research, influence, and implement vendor dependency to simplify the architecture.
• Implement, maintain, and update CI/CD pipelines on a cloud environment.
• Collaborate with business partners, architects, and other groups to identify complex technical and functional needs of systems based on priority.
• Collaborate with multiple, enterprise-wide distributed performing teams to deliver new capabilities in business applications.
• Design and develop APIs for Omni-channel clients.
• Build APIs and UIs to help make use of large data sets, infrastructure, and user experience.
• Own the full lifecycle for web software development, from ideas to production.
• Provides programming expertise and business analysis skills within broad business area, usually as a senior member of a project team, in analyzing, designing, modifying, and developing business applications.
• Create and educates on programming specifications from which programs will be written, and designs, codes, tests, debugs, and documents programs.
• Create and review programming documentations and recommend changes in development, maintenance, and application standards.
• Analyze and develop logical database designs, data models and relational data definitions across multiple computing environments (e.g., host based, distributed systems, client server, etc.)
• Comply with architectural standards and established methodologies and practices.

Send resume to and refer to job title to careers@vsgmgroup.com

Role: Embedded Software Engineer
Duration: 12 months
Location: CT/MA

• Bachelor’s degree in Electrical Engineering, Computer Engineering, or related discipline
•  5+ years’ experience in embedded software engineering, successfully utilizing C/C++ in a production environment. ARM assembly experience a plus.
•  Experience developing software on ThreadX operating system (experience with similar embedded RTOS may be considered).

Responsibilities:

• Design and implement portions of the software for an existing device working cross functionally to understand needs and requirements, and supporting the team with your technical expertise.
• Take part in the creation of schedules and tasking to facilitate the execution of development, completion, and delivery of software,
• Apply strong software engineering expertise to design and implement robust software architectures, while influencing the processes and methodologies used by the team to create quality software,

• Develop software that will be deployed in medical products using modern development practices such as: design patterns, strong object-oriented principles, unit testing, automated testing, and software evaluation tools

Send resume to and refer to job title to careers@vsgmgroup.com

Healthcare BA with Knowledge on HL7 and FHIR
Remote
6+ Months Contract

Job Description:

As a Business System Analyst, you will be a part of an Agile team to build healthcare applications and implement new features while adhering to the best coding development standards.

Required: 

• 9-10 years of Experience as a BSA.
• Healthcare Knowledge
• Having a very good working knowledge of FHIR and CCDA.
• Good Communication skills.

Send resume to and refer to job title to careers@vsgmgroup.com

Role: Health Care Business Analyst
Location : San Diego, CA(Onsite)
Position type : Contract
Project Duration : Long Term
Visa- USC/GC

Detailed JD :

Summary – The Business Systems Analyst III is a liaison between end-users/clients and the Information Technology department. The position is responsible for reviewing, analyzing, and evaluating the more complex business systems and user needs. Formulates systems to parallel overall business strategies; writes detailed description of user needs, program functions, and steps required to develop or modify computer programs. 

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Interviews end-users/customers to define business requirements for complex software modifications and enhancements. Meets with external clients to discuss enhancement requests as needed.   

Translates business requirements by reviewing, analyzing and evaluating needs into functional specifications.  Coordinates and responds to requests for changes from original specifications.    

Facilitates design sessions with the business and technical resources to ensure that the solutions meets the needs of the business.  Consults with technical teams on design and database issues.   

Defines and documents requirements business rules to assist in the development of software specifications to include system requirements, flow charts, report mock-ups, and business rules.  

Drives and/or leads projects to completion for assigned projects.  Develops project plans, prioritize project tasks, and provides regular status updates on project progress to management and stakeholders.  

Develops business processes that ensure developed application meets all project requirements. Ensures that projects are completed on time, accurate to defined specifications and within budget.  

 Performs quality control checks on software before it is released to the QA department.  Provides support to software development and QA staff as needed.

Send resume to and refer to job title to careers@vsgmgroup.com

 – Water & Steam Systems [WFI (water for injection)] – Onsite (Rocky Mount, NC)

Visa  – USC,GC

• Bachelor’s degree in engineering, science or related field.
• At least 10 years of experience in qualification activities for Pharmaceutical Industries.
• Experience in commissioning and qualification activities related to water pretreatment systems, high quality steam systems generation/distribution and water for injection systems
• Ability to interpret engineering drawings and discuss technical solutions associated with WFI systems.
• Hands on experience in the development of Life Cycle documents such as Project Validation Plans, User Requirement Specifications and Risk Assessments.
• Hands on experience in the elaboration and execution of FAT, Commissioning, SAT, Installation Qualification, Operational Qualification and Performance Qualification Protocols and Qualification Reports.
• Hands on experience in evaluation of welding activities, procedures and welding documentation.
• Hands on experience in the elaboration of Standard Operating Procedures for operation and maintenance of WFI systems.
• Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems.
• Knowledge in WFI guidelines from International Society of Pharmaceutical Engineering.
• Ability to manage resource planning, priorities, deliverables, and project schedule milestones.
• Strong interpersonal, verbal communication, and technical writing skills.

Send resume to and refer to job title to careers@vsgmgroup.com

Title: System Engineer
Type: Contract role
Location: Orlando, FL 
Job Description :

• In depth knowledge performing risk management per ISO 14971
• In depth knowledge in developing and testing products to IEC60601-1 Safety standard
• In depth knowledge in developing and testing products to IEC62336 EMC standard 

To succeed in this role, you should have the following skills and experience:

• BS degree in engineering
• Experience leading medical, or other regulated industry, product development
• Experience in leading groups to solutions for complex problems
• Experience with deriving and simulating human interactions with devices and device use conditions
• Experience with electronic requirement data management SW – preferably DOORS
• Minimum five years engineering / R&D experience in a rigorous quality-focused environment
• Minimum three years’ experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
• Excellent requirements and specification writing skills
• Demonstrated  deep understanding of US and international regulatory requirements for a heavily regulated product
• Ability to build and maintain effective cross-functional and cross-organizational relationships
• Excellent oral, written and presentation skills
• In depth knowledge performing risk management per ISO 14971
• In depth knowledge in developing and testing products to IEC60601-1 Safety standard
• In depth knowledge in developing and testing products to IEC62336 EMC standard

Send resume to and refer to job title to careers@vsgmgroup.com

Job Role: Electrical Engineer II – PCBA
Location: Marietta, OH
Hire Type: Contract

Job Description:

The Electrical Engineer III – PCBA is a key member of the Technical Sourcing Engineering (TSE) team responsible for the technical management of our EM/M and OEM supply base. (S)he will drive risk mitigation efforts, cost savings initiatives, product scale up, provide NPI support and guidance, resolve quality issues, and supplier consolidation.

What will you do?

• As part of the technical sourcing engineering team, you will work closely with R&D, product development, quality and procurement to mitigate risk in our PCBA supply base.
• Work with a team of electrical engineers including Staff Electrical Engineers for support.
• Have your own set of projects.
• Identify risk components and designs and provide alternate component or design solutions to mitigate risk.
• Primary focus will be on PCBA’s, with future opportunities in electromechanical components, electromechanical assemblies, and OEM assemblies.
• Focus will be on GPS products in LE Division
• Travel will be up to 10% global.
• How will you get here?

Education:

• Bachelor’s or master’s in electrical, Electronics Engineering, Mechatronics or Physics

Experience:

• BS with 4+ years’ experience, or, MS with 2+ years’ experience: hands on product design, product development, and manufacturing experience
• Experience in either: PCBA Design and/or component engineering
• Strong project management skills
• Demonstrated ability to manage vendors, contract manufacturers, and design firms.
• Value engineering, process development, should-cost modeling experience, DFA/DFM/DFx experience
• Relevant experience managing electromechanical suppliers and contract manufacturers.
• Experience dealing with electromechanical devices that are regulated by third party agencies such as FDA, NSF, CSA, UL, ISO 13485 standard and others in the medical products industry.
• Proficiency in PCBA CAD Design software, SolidWorks, Pro/e, or equivalent
• Understanding of phase gate development processes and methodologies across multiple disciplines and subject matters is preferred.
• Medical devices experience preferred.

Send resume to and refer to job title to careers@vsgmgroup.com

Job Role: Regulatory Affairs IVDR Technical Documentation Consultant

 Background: The client is a large medical device company that specializes in Invitro Diagnostics products and devices. They are seeking a high level Regulatory Affairs Consultants to support technical documentation. The main responsibilities of this consultant will be to help with IVDR technical documentation as well as working cross functionally with stakeholders and other groups. Additionally, this candidate will have to have direct experience managing and reviewing responses and relationships with notified bodies (BSI)

Project: The consultant will join the Regulatory Affairs team focusing on IVD products.  This role will consist of hands-on execution work as well as interfacing and working directly with cross-functional core project teams. The consultant will need to have both hands-on Regulatory Affairs experience and excellent communication skills in order to succeed in this position. 

Required:
US and Global Submissions Experience

Technical Documentation Experience
Notified Body Experience (BSI)
IVDR Product Experience
Leading/Interfacing with Cross Functional teams

Send resume to and refer to job title to careers@vsgmgroup.com