Project Engineer/Manager - Medical Device - Durham, NH

The Project Engineer/Manager leads and manages medical device product development and manufacturing transfer projects from concept through production. The position combines hands-on engineering design, regulatory compliance, and project management to deliver high-quality products in a fast-paced, startup-like environment.

Client Details

Our client is a medical device manufacturer specializing in developing and producing innovative, high-quality products for regulated healthcare markets. They operate in a fast-paced, startup-like environment that values hands-on problem solving, cross-functional collaboration, and continuous improvement.

Description

This Project Engineer/Manager will:

• Lead NPD and manufacturing transfer projects from concept through production.
• Evaluate and improve new and existing designs, processes, and tooling.
• Perform hands-on design of components, molds, and thermoformed packaging using SolidWorks and CAD.
• Communicate directly with customers via project meetings and technical updates.
• Oversee manufacturing line startups, validations (IQ/OQ/PQ/PPQ, TMV), and process documentation.
• Ensure compliance with FDA QSR, ISO 13485, and GMP standards.
• Drive continuous improvement, cost reduction, and lean initiatives.
• Collaborate cross-functionally and mentor junior engineers to strengthen project execution.

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.

Profile

A successful Project Engineer/Manager should have:

• Bachelor's degree in Mechanical, Biomedical, or Systems Engineering.
• 6-7+ years' experience in regulated medical device manufacturing or product development.
• Proficient in SolidWorks/CAD, thermoforming, mold design, and machining.
• Hands-on experience with sterile packaging and manufacturing validations (IQ/OQ/PQ/PPQ, TMV).
• Knowledge of FDA QSR, ISO 13485, GMP standards, and medical device manufacturing processes.
• Strong project management skills, including planning, scheduling, and cross-functional coordination.
• Excellent communication, collaboration, and leadership abilities.
• Customer-facing, proactive, and solutions-oriented, with a hands-on, 'wear many hats' mindset.

Job Offer

• Performance-based bonus opportunity.
• Flexible work hours (7:00AM-3:30PM or 8:00AM-4:30PM).
• Hands-on, impactful role in a fast-paced medical device environment.
• Exposure to cross-functional teams, executive stakeholders, and regulated product development.
• Opportunity for career growth, mentorship, and skill development in an innovative setting.

Apply today for immediate consideration!

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.