Project Engineer - Medical Device Manufacturing

The Project Engineer will be a key leader in the execution of medical device manufacturing and product development projects, ensuring delivery within scope, on time, and in alignment with company goals. In this role you will be customer facing, communicating with them directly to ensure that projects are moving along smoothly. Client Details

My client is a contract manufacturing specializing in medical device and life science products, offering end-to-end services including assembly, sterilization, packaging, and regulatory support. They take pride in helping companies bring products to market faster while ensuring full compliance with FDA and ISO 13485 standards.

Description

The key responsibilities for the Project Engineer include, but are not limited to:

• Leading and coordinating all phases of new product development (NPD) and manufacturing transfer projects from concept through production launch.
• Designing products and tooling using SolidWorks and other CAD tools.
• Acting as the primary interface between internal teams and external customers to align on objectives, deliverables, and timelines.
• Creating and managing project documentation, including schedules, budgets, resource allocations, and risk mitigation plans.
• Collaborating across functions-R&D, Quality, Regulatory, Manufacturing, Marketing, and Supply Chain-to ensure successful project execution.
• Managing the launch of new production lines, including procedure creation, line clearance, and training of operators.
• Providing hands-on support and training for manufacturing processes and quality system compliance (FDA QSR, ISO 13485).
• Supporting validation efforts such as IQ/OQ/PQ/PPQ, Test Method Validation (TMV), and process characterization.
• Mentoring junior engineers and contributing to the team's growth in project management and engineering practices.
• Identifying cost-saving opportunities through lean initiatives, process enhancements, and automation.
• Supporting environmental, health, and safety (EHS) standards and promoting a safety-focused culture.

Profile

The successful Project Engineer should have the following qualifications:

REQUIRED QUALIFICATIONS

• Bachelor's degree in Mechanical, Biomedical, or Materials Engineering (or related field).
• 4+ years of experience in regulated medical device manufacturing or product development.
• Demonstrated success in managing complex projects or programs.
• Proficiency in Microsoft Office and project management software.
• Skilled in SolidWorks and related design tools.
• Strong communication, documentation, and organizational abilities.
• Solid understanding of FDA regulations, ISO 13485, and GMP standards.

PREFERRED QUALIFICATIONS

• PMP certification or equivalent project management credentials.
• Experience with Class I, II, or III medical device manufacturing.
• Background in engaging executive stakeholders and cross-functional teams.
• Familiarity with enterprise system implementations and large-scale initiatives.

Job Offer

• Competitive compensation
• Comprehensive benefits package
• 401K with company match
• Full health insurance including medical, dental and vision
• Generous PTO
• 11 paid holidays
• Great company culture with room for career growth!

We encourage qualified candidates to 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.