Sr. Mechanical Engineer - Medical Device Leads #3664

ECI; Arden Hills (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in the life sciences industry is seeking a Sr. Mechanical Engineer to develop and sustain medical device systems. The role involves leading design projects, ensuring compliance with regulations, and mentoring junior engineers. This position offers the opportunity to work on innovative medical solutions in a collaborative environment.

Qualifications

• At least 7 years of design experience in the medical device industry.
• Experience with durable medical equipment and single-use devices.

Responsibilities

• Lead design and development activities, ensuring compliance with design control standards.
• Collaborate with product managers, engineers, and clinicians.
• Mentor junior engineers and support personnel.

Skills

Communication

Technical Writing

Team-oriented

Engineering

Design

Analysis

Education

Bachelor’s Degree in Engineering

Job description

Sr. Mechanical Engineer - Medical Device Leads #3664

Join to apply for the Sr. Mechanical Engineer - Medical Device Leads #3664 role at ECI

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. We leverage diverse perspectives and decades of expertise to tackle challenging projects, providing transformative solutions with sustainable, long-term value. Our collaborative culture, welcoming team, and flexible employment options help us maintain strong relationships with talented industry professionals.

Role Overview

The Sr. Mechanical Engineer develops new products and sustains current medical device systems, including leads, with minimal supervision. As a team lead, you will develop, direct, and execute plans for design and development projects, ensuring compliance with design control requirements.

Key Responsibilities

• Lead design and development activities, including product design, testing, specifications, risk management, usability studies, process capability, and documentation, ensuring compliance with design control standards.
• Support gap assessments and remediation of DHFs/Technical Files in accordance with 21 CFR 820.30 and EU MDR requirements.
• Develop and validate new or revised test methods.
• Fabricate and evaluate materials, components, devices, test fixtures, and prototypes.
• Generate, review, and approve design control documentation.
• Perform design verification and validation.
• Identify opportunities for device improvements in quality, cost, and performance.
• Lead technical teams, conduct meetings, and manage project timelines.
• Collaborate extensively with product managers, engineers, technicians, suppliers, and clinicians.
• Mentor junior engineers and support personnel.
• Ensure quality and regulatory compliance in all work activities.
• Perform additional duties as required.

Qualifications

• Bachelor’s Degree in Engineering or equivalent experience.
• At least 7 years of design experience in the medical device industry.
• Experience with durable medical equipment and single-use devices; experience designing leads is highly preferred.
• Strong communication, technical writing, and presentation skills.
• Team-oriented attitude with excellent engineering, design, and analysis skills.
• Experience from concept to commercialization of medical devices.
• Understanding of FDA QSR and EU MDR regulations.

Additional Information

ECI is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity, or other protected statuses. Candidates must be authorized to work in the U.S. without sponsorship now or in the future.

Job Details

• Seniority Level: Mid-Senior level
• Employment Type: Full-time
• Job Function: Engineering and Information Technology
• Industry: Business Consulting and Services