Sustaining Engineer

Principal Sustaining Engineer

Job Description:

We are seeking a highly skilled and experienced Principal Sustaining Engineer to lead the support and improvement of existing medical device products throughout their lifecycle. This contract role is pivotal in ensuring the continued performance, safety, and regulatory compliance of our medical devices. The successful candidate will work cross-functionally with Quality, Manufacturing, Regulatory, and other teams to drive product improvements, cost reductions, and design optimizations.

Responsibilities:

+ Lead sustaining activities, including design modifications, process improvements, and component/material changes, ensuring product quality and reliability.

+ Provide technical expertise to resolve product performance issues, field complaints, and non-conformances.

+ Conduct root cause analysis and implement corrective and preventive actions (CAPA) for product issues.

+ Collaborate with cross-functional teams to assess and implement design changes, ensuring compliance with regulatory requirements.

+ Support manufacturing teams, both internal and contract manufacturing, in troubleshooting production issues and optimizing processes.

+ Evaluate and qualify alternate materials, suppliers, and manufacturing processes to ensure continuity of supply and cost-effectiveness.

+ Prepare and review technical documentation, including engineering change orders (ECOs), risk assessments, test protocols, and validation reports.

+ Ensure compliance with medical device regulations (FDA, ISO, MDR) and contribute to audits and regulatory submissions as needed.

+ Mentor junior engineers and contribute to knowledge sharing within the R&D team.

+ Stay updated on industry trends, emerging technologies, and regulatory changes to drive continuous improvement initiatives.

Essential

Skills:

+ Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline. Master's degree preferred.

+ Minimum of 10 years of experience in R&D, sustaining engineering, or product development within the medical device industry.

+ Deep understanding of medical device regulations and standards, including FDA 21 CFR Part 820 and EU MDR.

+ Strong knowledge of risk management (ISO), design control, and verification/validation processes.

+ Proficiency in engineering tools such as CAD (Solid Works), FMEA, and statistical analysis.

+ Experience working in a cross-functional environment and leading product improvement initiatives.

+ Strong analytical and problem-solving skills, with a hands-on approach to technical challenges.

+ Excellent communication and project management skills, with the ability to work in a fast-paced, regulated environment.

Job Type & Location

This is a Contract to Hire position based out of Maple Grove, MN.

Pay and Benefits

The pay range for this position is $60.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision  - Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available  - Life Insurance (Voluntary Life & AD&D for the employee and dependents)  - Short and long-term disability  - Health Spending Account (HSA)  - Transportation benefits  - Employee Assistance Program  - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Maple Grove,MN.

Final date to receive applications

This position is anticipated to close on Jun 10, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccom for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

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