Medical Device Project Manager

The Fountain Group LLC

Boston, MA

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JOB DETAILS

SALARY

$124.61–$138.46 Per Hour

SKILLS

Biomedicine, CMOS, Clinical Support, Code of Federal Regulations, Consulting, Contract Management, Contract Manufacturing, Cross-Functional, Design Verification, Documentation, Drug Delivery Devices, Drug Implants, Electrical Engineering, FDA (Food and Drug Administration), FDA Requirements, Human Factors, ISO (International Organization for Standardization), Implants, Leadership, Manufacturing, Manufacturing Management, Manufacturing Requirements, Mechanical Engineering, Medical Equipment, Medical Products, Product Management, Project Design, Project Planning, Project/Program Management, Regulations, Regulatory Reports, Regulatory Submissions, Risk Management, Supply Chain, Technical Writing, Test Bench, Test Plan/Schedule, Traceability, Validation Testing

LOCATION

Boston, MA

POSTED

20 days ago

Pay: $124.61-138.46/hour. W2 Only.
Duration:7 months (through end of 2026) with extensions based on client need and performance.
Location: Local to Boston able to work onsite as needed highly preferred. Open to exceptionally well qualified remote candidates.

Industry: Medical Devices – Class III Long-Term Implantable Devices / Drug Delivery

About the Role
We are seeking an experienced Project Manager (Consultant) to support the development, testing, and Premarket Approval (PMA) submission of a Class III long-term implantable medical device within the Implantable Device Unit (IDU). This role will provide end-to-end project leadership across design, verification and validation, manufacturing readiness, and regulatory submission activities. The Project Manager will partner closely with Device Development, Regulatory Affairs, Quality, Manufacturing, and external partners to ensure execution remains aligned with FDA expectations, design control requirements, and program timelines.

Key Responsibilities
- Lead integrated project plans focused on finalizing design control deliverables and completing PMA Modules, ensuring alignment with regulatory milestones and submission timelines.
- Drive execution of remaining verification and validation activities, ensuring traceability, documentation completeness, and readiness for regulatory review.
- Partner with Regulatory Affairs and Quality to ensure all development, testing, and manufacturing activities comply with FDA PMA requirements, Design Controls (21 CFR 820), risk management (ISO 14971), and applicable standards.
- Support EU MDR transition activities, including gap assessments, documentation updates, and alignment of technical documentation with MDR expectations.
- Provide oversight of device design verification (DV) activities, ensuring completion of DV testing, reporting, and cross-functional alignment to support PMA design control deliverables.
- Coordinate validation activities including human factors, bench testing, and clinical feedback incorporation, ensuring protocols and reports meet regulatory expectations.
- Manage clinical product manufacturing supply chain activities as needed, including close day-to-day coordination with Contract Manufacturing Organizations (CMOs) to support clinical supply, process readiness, and PMA Modules deliverables.

Qualifications Required
- Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or a related technical discipline is required.
- 7–12+ years of experience managing complex medical device programs, preferably Class III implantable devices is required.
- Strong working knowledge of FDA PMA submissions, Design Controls, and regulated manufacturing environments is required.
- Demonstrated experience coordinating cross-functional and external teams in late-stage, submission-focused programs is needed.

Preferred Skills:
- Experience supporting PMA completion and regulatory interactions.
- Experience supporting EU MDR transition for legacy or late-stage medical devices.
- Hands-on experience working with CMOs and clinical manufacturing supply chains.

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About the Company

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.thefountaingroup.com/

Medical Device Project Manager

The Fountain Group LLC

Boston, MA

About the Company

The Fountain Group LLC

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