Medical Device - Project Engineer - Rochester, NH

Michael Page; Rochester (NH); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Competitive compensation and benefits package

Professional development and mentorship opportunities

Job summary

A leading recruitment firm is seeking a qualified Project Engineer in Rochester, NH, to lead medical device product development and manufacturing projects. The role requires a Bachelor's degree in Mechanical, Biomedical, or Systems Engineering, with over 4 years of experience in regulated environments. Responsibilities include managing cross-functional teams and supporting production start-up activities. This full-time position offers competitive compensation and opportunities for professional development in a collaborative environment.

Qualifications

• 4+ years in regulated medical device manufacturing or product development.
• Strong project management experience; PMP certification preferred.
• Knowledge of FDA QSR, ISO 13485, and GMP standards.

Responsibilities

• Lead new product development and manufacturing transfer projects.
• Coordinate cross-functional teams and performance validations.
• Drive continuous improvement and cost-saving initiatives.

Skills

Project management

SolidWorks

Mechanical Engineering

Regulatory compliance

Education

Bachelor's degree in Mechanical, Biomedical, or Systems Engineering

Tools

Microsoft Office Suite

Machining equipment

Job description

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.

Base pay range

$115,000.00/yr - $135,000.00/yr

Responsibilities

• 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.

Ideal Candidate

• 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.

Seniority Level

• Entry level

Employment Type

• Full‑time

Job Function

• Engineering and Manufacturing

Industries

• Medical Equipment Manufacturing, Packaging and Containers Manufacturing, and Plastics Manufacturing

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.