Senior Project Manager (Manufacturing)Global Interconnect Inc • Pocasset, Massachusetts, United States
Dieses Stellenangebot ist nicht mehr verfügbar
Senior Project Manager (Manufacturing)
Global Interconnect Inc
- Pocasset, Massachusetts, United States
- Pocasset, Massachusetts, United States
Über
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
Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot wurde von einem unserer Partner veröffentlicht. Sie können das Originalangebot einsehen hier.