Manufacturing Project Manager - Medical Device - Billerica, MA

Billerica Permanent USD100,000 - USD120,000 per year
  • Leadership opportunity with a growing team
  • Work on exciting life saving medical devices

About Our Client

Our client is a top medical device CDMO located in the Greater Boston area. They are a mid-sized, well established company that focuses on taking life saving devices designs from concept all the way through manufacturing, and looking to grow their team.

Job Description

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
  • Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Reliable, consistent and punctual attendance is an essential function of the job.
  • Other duties as assigned. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Minimum BS in a relevant engineering discipline
  • 5 years of experience within the medical device industry.
  • Minimum 2 years of experience in project / program management of medical device development.
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
  • Must have proficiency in MS Project and other MS Office software.

What's on Offer

  • Competitive compensation
  • Excellent PTO and benefits
  • Great growth opportunity
Jamie Brewer
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Job summary

Engineering & Manufacturing
Sub Sector
Project / Program Management
Industrial / Manufacturing
Contract Type
Consultant name
Jamie Brewer
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