Medical Device - Product Life Cycle Engineer - Woburn, MA

The Product Lifecycle Engineer will be responsible for managing product lines throughout their entire lifecycle. You will collaborate with teams across R&D, Quality, Regulatory, and Manufacturing to support regulatory submissions, maintain market compliance, and develop engineering solutions that enhance the safety, quality, and performance of medical devices across various classifications.

Client Details

Our client is a global innovator in the development and manufacturing of devices and services for the treatment of vascular disease. With a focus on collaboration and teamwork, it provides essential solutions that help surgeons deliver better outcomes for their patients.

Description

Responsibilities:

• Collaborate with cross-functional teams to ensure all product requirements, both internal and external, are up-to-date and fully integrated into product development.
• Perform gap analyses on technical documentation and recommend improvements, initiating change orders for necessary updates.
• Identify, initiate, and manage design and process improvement projects aimed at enhancing device safety, quality, and performance.
• Support the CAPA process by ensuring product compliance with international standards, regulations, and internal requirements.
• Create protocols, generate reports, and conduct product testing to address gaps in Design V&V.
• Build strong relationships with multi-functional leaders to ensure alignment and effective execution of business objectives.
• Advocate for the voice of the customer in all decision-making, ensuring user needs are transformed into actionable design requirements that can be verified and validated.
• Ensure projects adhere to regulatory standards (GMP, GDP, ISO, EU MDR) and company policies and procedures.
• Capture and share insights gained during projects to enhance company processes and systems.

Profile

Ideal Candidate:

• Bachelor's degree in Engineering or a related technical field.
• At least 3 years of relevant experience with a proven record of success, including direct involvement in sustaining or developing products throughout their lifecycle.
• Strong problem-solving and execution skills, with the ability to devise creative solutions to complex challenges and achieve project goals.
• Familiarity with design controls and experience in developing devices by defining user needs, translating them into design inputs, and understanding the purpose of Verification and Validation testing.
• Ability to manage and prioritize schedule, cost, and quality considerations effectively.
• In-depth understanding of new product development processes or change management practices within the medical device or IVD industry.
• Proficiency in statistical techniques and their practical applications.
• Exceptional communication, teamwork, and influencing abilities.
• Proven ability to deliver project outcomes in dynamic and ambiguous environments.

Job Offer

What's To Offer:

• Competitive compensation package with opportunities for financial growth.
• Extensive health and wellness benefits.
• Career development programs and mentorship.
• Creative, collaborative work environment.
• Flexible work arrangements for work-life balance.
• Access to cutting-edge technologies and continuous learning.
• Involvement in high-impact, innovative projects.

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.