Project Engineer - Dover, NH - Manufacturing

The Project Engineer is a key leader in managing and executing medical device manufacturing and product development initiatives. This role ensures projects are delivered on time, within scope, and in compliance with FDA Quality System Regulations and ISO 13485 standards, while driving innovation and efficiency.

Client Details

My client is a leading provider of comprehensive services for medical device development and manufacturing. They offer integrated solutions that include product assembly, packaging, sterilization, and validation testing, all designed to meet stringent regulatory standards.

Description

The Project Engineer will:

• Lead all phases of new product development (NPD) and manufacturing transfer projects for medical devices.
• Perform hands-on design work using CAD (SolidWorks), 3D printing, and machining tools.
• Act as the primary liaison between internal teams and customers to align on strategy and deliverables.
• Develop and maintain project documentation including schedules, budgets, and risk assessments.
• Coordinate cross-functional activities across R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain.
• Oversee new production line startups, including procedure development and operator training.
• Support validation activities (IQ/OQ/PQ/PPQ, TMV, Process Characterization).
• Drive continuous improvement in project execution and quality systems.
• Communicate project status, risks, and mitigation plans to stakeholders and leadership.
• Mentor junior engineers and foster best practices in project management and engineering.
• Collaborate with suppliers to resolve issues and identify cost-saving opportunities.
• Ensure compliance with EHS requirements and promote a culture of safety.

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 should have the following qualifications:

• Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field.
• Minimum 7 years of experience in regulated medical device manufacturing or product development.
• Strong project management experience with complex programs.
• Proficiency in Microsoft Office, project management tools, and SolidWorks.
• Knowledge of FDA regulations, ISO 13485, GMP, and medical device assembly processes.
• Hands-on approach with a strong sense of ownership and craftsmanship.
• PMP certification or equivalent.
• Experience with Class I/II/III medical devices and startup environments.
• Familiarity with machining processes and enterprise-wide system implementations.
• Ability to influence without authority and manage competing priorities in a fast-paced setting.
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Job Offer

• Competitive salary ranging from $125,000 to $135,000 USD.
• Comprehensive benefits package as per offer.
• Opportunity to work on impactful engineering projects
• Supportive and collaborative work environment.
• Room for professional development and career growth.

If you are ready to take on this exciting opportunity as a Project Engineer, we encourage you to apply today!

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.