Job Summary:

We are a leading contract manufacturer specializing in the production of high-quality medical devices and sub-assemblies for OEM clients in the healthcare industry. We are seeking an experienced Senior Project Manager to lead complex new product introduction (NPI) in a highly regulated environment. The Senior Project Manager will serve as the primary point of contact for clients while driving internal cross-functional teams to deliver projects on time, within budget, and in full compliance. This role requires strong leadership, risk management skills, and a deep understanding of medical device manufacturing processes from prototype through full-scale production.

Key Responsibilities

Serve as the main interface between the client (OEM) and internal teams, managing expectations, providing regular status updates, and ensuring clear communication throughout the project lifecycle.
Lead end-to-end project management for NPI programs — from initial quote/scope definition through design, verification and validation, production ramp, and stabilization.
Develop and maintain comprehensive project plans, integrated timelines (Gantt charts), budgets, resource plans, and risk registers using tools such as MS Project, Smartsheet, or similar.
Coordinate cross-functional teams including Sales, Engineering, Quality, Manufacturing, and Supply Chain to ensure alignment and execution.
Identify, assess, and mitigate project risks; proactively resolve issues that could impact quality, compliance, cost, or schedule.
Ensure all project activities comply with design controls, risk management, process validation (IQ/OQ/PQ), change control, and documentation requirements.
Manage project scope, change orders, and client variations while maintaining profitability targets and contractual obligations.
Track and report key project metrics (schedule adherence, budget variance, milestone completion, quality KPIs) to senior leadership and clients.
Facilitate project phase reviews.
Drive continuous improvement initiatives to enhance project delivery efficiency and client satisfaction.

Qualifications Required

Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial), Life Sciences, or a related technical field; PMP certification or equivalent preferred.
5+ years of project management experience in medical device manufacturing, preferably in a contract manufacturing environment.
Proven track record managing NPI, technology transfers, or production scale-up projects for Class I/II (and ideally Class III) medical devices.
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, risk management, and design controls.
Experience working in cleanroom environments and with regulated manufacturing processes (e.g., assembly, injection molding, sterilization, packaging).
Excellent organizational, leadership, and interpersonal skills with the ability to influence without direct authority.
Proficiency with project management tools (MS Project, Jira, Smartsheet, etc.) and MS Office Suite.
Demonstrated ability to manage multiple concurrent projects in a fast-paced environment.

Preferred

Master's degree or advanced certification (PMP, Six Sigma Green/Black Belt).
Experience with catheter-based devices, electromechanical assemblies, sterile packaging, or complex assemblies.
Familiarity with client contract negotiation, statement of work (SOW) development, and change order management.
Previous experience interacting directly with OEM clients and regulatory bodies.

What We Offer

Competitive salary and performance-based bonus
Comprehensive benefits package (health, dental, vision, 401(k) with match)
Opportunities for professional development in a growing medtech organization
Collaborative environment focused on quality, innovation, and patient safety

If you are a results-oriented project leader passionate about bringing life-saving medical devices to market through contract manufacturing excellence, we invite you to apply.

Pay: $95,000.00 - $135,000.00 per year

Benefits:

401(k)
401(k) matching
Flexible schedule
Flexible spending account
Health insurance
Professional development assistance
Retirement plan

Work Location: Hybrid remote in Pocasset, MA 02559

Global Interconnect Inc

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