Medical Device - Project Engineer - Rochester, NH

The Project Engineer will oversee medical device product development and manufacturing projects from concept through production. This role combines hands-on engineering with project leadership, ensuring timely delivery, regulatory compliance, and alignment with company objectives.

Client Details

My client is an innovative medical device manufacturer focused on delivering high-quality products that meet stringent regulatory standards. The organization values craftsmanship, continuous improvement, and collaboration across all functions.

Description

• Lead new product development (NPD) and manufacturing transfer projects.
• Perform hands-on design using SolidWorks, 3D printing, and machining tools.
• Develop project documentation including schedules, budgets, and risk assessments.
• Coordinate cross-functional teams (R&D, Quality, Regulatory, Manufacturing, Marketing, Supply Chain).
• Support validation activities (IQ/OQ/PQ/PPQ, TMV, Process Characterization).
• Oversee production line startups and operator training.
• Drive continuous improvement and cost-saving initiatives.
• Mentor junior engineers and contribute to SOP and training material development.

Profile

• Bachelor's degree in Mechanical, Biomedical, or Systems Engineering.
• 4+ years in regulated medical device manufacturing or product development.
• Strong project management experience; PMP certification preferred.
• Proficient in SolidWorks and Microsoft Office Suite.
• Knowledge of FDA QSR, ISO 13485, GMP, and medical device assembly processes.
• Hands-on experience with machining and manufacturing equipment.
• Ability to influence without authority and thrive in a fast-paced environment.

Job Offer

• Opportunity to lead impactful projects in a growing medical device company.
• Collaborative, small-team environment with exposure to executive stakeholders.
• Competitive compensation and benefits package.
• Professional development and mentorship opportunities.

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.