Medical Device - Project Engineer - Rochester, NH

As a Project Engineer, you will lead and manage key projects in the medical device industry, driving product development and manufacturing transfers from concept through production. You'll collaborate closely with customers and cross-functional teams, utilizing your engineering expertise to design solutions, ensure quality compliance, and optimize manufacturing processes. Your contributions will directly impact project success and company growth.

Client Details

My client is a contract manufacturer that has supported the medical device industry with specialized services including assembly, packaging, medical package testing, sterilization, thermoforming, and custom design. With a growing team of over 200 employees, the company is positioned for continued expansion and innovation in the healthcare space.

Description

Responsibilities:

• Lead new product development (NPD) and manufacturing transfer projects for medical device programs from concept through production launch.
• Serve as the primary point of contact between customers and internal teams to ensure alignment on project goals, timelines, and deliverables.
• Design products and thermoformed tooling using SolidWorks, with a hands-on approach to engineering challenges.
• Manage detailed project documentation including schedules, budgets, resource plans, and risk assessments.
• Coordinate cross-functional collaboration between R&D, Quality, Regulatory, Manufacturing, and Supply Chain.
• Support new production line startups, including procedure development, operator training, and process validation.
• Ensure manufacturing documentation, work orders, and procedures comply with FDA QSR, ISO 13485, and internal quality standards.
• Oversee and support validation activities (IQ/OQ/PQ/PPQ, TMV) and process characterization.
• Identify and implement process improvements and cost-saving opportunities through lean practices and automation.
• Mentor junior engineers and promote best practices in engineering, documentation, and project execution.

Profile

Ideal Candidate:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field.
• 4+ years of experience in regulated medical device manufacturing or product development.
• Strong problem-solving mindset with natural curiosity-consistently looks for ways to improve processes, products, and systems.
• Demonstrated ability to think and act independently, identifying issues and driving them to resolution without needing step-by-step direction.
• Hands-on engineering approach: can walk into a space, analyze, assess, and make sound, data-driven decisions.
• Comfortable working directly with customers, particularly in the medical manufacturing space, to understand needs and deliver custom packaging solutions.
• Experience designing thermoformed parts and tooling; understands mold-making and manufacturing of plastic components.
• Proficient in SolidWorks (CAD) and modeling, with strong design-for-manufacturing sensibility.
• Effective communicator-leads weekly meetings with customers and cross-functional teams to keep projects on track.
• Organized and detail-oriented, with strong documentation and project tracking skills.
• Familiar with FDA regulations, ISO 13485 standards, and GMP requirements.
• Proficient in Microsoft Office and project management tools.

Job Offer

What's To Offer:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

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.