Principal Sustaining Engineer

Key Responsibilities

• Lead sustaining engineering 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.

Skills, Knowledge, Experience, Qualifications

• 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 (SolidWorks), 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.

Compensation

Target base salary range: $60 - $80 /hr. Final compensation will be based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• The chance to be part of a growing company that values its people.

Note

This is the national market pay scale. Salary Range: $60 - $80 USD