Product Engineer - Medical Device - Burlington, MA

The Product Life-cycle Engineer will manage and sustain medical device product lines throughout their life-cycle, collaborating with cross-functional teams to ensure compliance, quality, and safety. The role involves conducting gap assessments, leading design and process improvements, and ensuring regulatory compliance while maintaining strong partnerships across the organization.

Client Details

The client is a leading medical device company focused on developing and delivering high-quality, safe, and effective devices across various classes, including Class I, II, and III. They are committed to innovation, regulatory compliance, and continuous improvement throughout the entire product life cycle to meet the evolving needs of patients and health care professionals.

Description

• Collaborate with cross-functional teams to ensure all internal and external product requirements are fully applied and up-to-date across all products.
• Conduct gap assessments of product technical documentation, providing recommendations for improvements and initiating change orders to implement necessary changes.
• Identify, launch, and coordinate design and process improvement projects to enhance the safety, quality, and efficacy of medical devices.
• Contribute to the CAPA (Corrective and Preventive Action) process, ensuring product compliance with internationally recognized standards and regulations, as well as internal requirements.
• Draft protocols and reports, and execute product testing to address any gaps identified in Design Verification & Validation (V&V).
• Ensure all projects are executed in compliance with regulatory requirements (GMP, GDP, ISO, EU MDR) and our client's internal policies and procedures.

Profile

Bachelor's in Engineering (Mechanical/BioMedical).

3+ Years of Product Management Experience.

Strong design control skills.

Well versed in new product development.

Working knowledge of regulated industry.

Job Offer

Competitive Base Salary of $100,000-$120,000

Bonus structure

Great health benefits

Flexible work schedule

Strong Company culture

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.