Sustaining Engineer

The Sr. or Principal Sustaining Engineer is a highly skilled and experienced technical leader responsible for supporting and improving existing products throughout their lifecycle. This contract role is pivotal in ensuring the continued performance, safety, and regulatory compliance of company medical devices. The engineer will work cross‑functionally with Quality, Manufacturing, Regulatory, Quality and other teams to drive product improvements, cost reductions, and design optimizations.

• 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 13485, 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.

Medical device, research & development, product development engineering, mechanical engineering, iso 13485, iso 14971, design control, verification testing, validation verification, validation engineering, solidworks, fmea, statistical analysis, root cause failure analysis, Design, regulatory compliance, manufacturing process

• 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, ISO 13485, and EU MDR.
• Strong knowledge of risk management (ISO 14971), 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.

This is a Contract position based out of Saint Paul, MN. This is a fully onsite position in Saint Paul, MN.

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

• 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)

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.