Sustaining Engineer

Responsibilities

• Lead sustaining engineering activities for existing medical devices, including design modifications, process improvements, and component or material changes to maintain and enhance product quality and reliability.
• Provide advanced technical expertise to investigate and resolve product performance issues, field complaints, and non-conformances in a timely and systematic manner.
• Conduct thorough root cause analysis of product issues and implement effective corrective and preventive actions (CAPA) to prevent recurrence.
• Collaborate closely with cross-functional teams, including Quality, Manufacturing, Regulatory, and other stakeholders, to assess, plan, and implement design changes while maintaining regulatory compliance.
• Support internal manufacturing teams and contract manufacturing partners by troubleshooting production issues, resolving technical problems, and optimizing manufacturing processes.
• Evaluate, select, and qualify alternate materials, suppliers, and manufacturing processes to ensure continuity of supply, cost-effectiveness, and product performance.
• Prepare, review, and maintain technical documentation such as engineering change orders (ECOs), risk assessments, test protocols, and validation reports to support design and process changes.
• Ensure compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, EU MDR, and other relevant requirements, and contribute to internal and external audits and regulatory submissions as needed.
• Apply rigorous design control practices and oversee verification and validation activities to ensure changes meet functional, safety, and regulatory requirements.
• Use engineering tools such as CAD (SolidWorks), FMEA, and statistical analysis to support design decisions, risk assessments, and process improvements.
• Lead product improvement initiatives within R&D and sustaining engineering, focusing on performance, reliability, cost reduction, and manufacturability.
• Mentor and guide junior engineers, sharing best practices and fostering a culture of knowledge sharing and continuous improvement within the engineering team.
• Stay current on industry trends, emerging technologies, and evolving regulatory requirements, and incorporate these insights into continuous improvement initiatives and long-term product strategies.
• Collaborate with research and development teams to ensure that sustaining activities align with broader product development and lifecycle management goals, particularly in structural heart and catheter-based technologies.

Requirements

• Minimum of 10 years of experience in R&D, sustaining engineering, or product development within the medical device industry.
• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Extensive experience with medical device sustaining activities, including design changes, process improvements, and lifecycle support.
• Deep understanding of medical device regulations and quality system requirements, including FDA 21 CFR Part 820 and EU MDR.
• Strong knowledge of risk management practices in accordance with relevant ISO standards, including application of FMEA and other risk analysis tools.
• Demonstrated experience with design control processes, including requirements management, design verification, and design validation.
• Hands-on experience with verification testing and validation engineering for medical devices.
• Proficiency with CAD tools, particularly SolidWorks, for mechanical and product design activities.
• Strong capability in statistical analysis to support verification, validation, and process improvement activities.
• Demonstrated experience with root cause failure analysis and implementation of effective CAPA solutions.
• Experience with manufacturing processes for medical devices, including collaboration with internal and contract manufacturing organizations.
• Demonstrated ability to work effectively in a cross-functional environment and to lead product improvement initiatives.
• Strong analytical and problem-solving skills with a practical, hands-on approach to technical challenges.
• Excellent communication skills, both written and verbal, with the ability to prepare clear technical documentation and interact with diverse stakeholders.
• Solid project management skills and the ability to manage multiple priorities in a fast-paced, regulated environment.

Essential Skills

• Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field is preferred.
• Experience with structural heart, catheter-based technologies, or similar complex medical devices.
• Work history in research and development or product development engineering for medical devices.
• Familiarity with ISO-based quality and risk management standards applicable to medical devices.
• Experience supporting audits and regulatory submissions related to design changes and sustaining activities.
• Demonstrated ability to mentor junior engineers and contribute to building a high-performing engineering team.
• Interest in and awareness of emerging technologies, industry trends, and advancements in cardiac care and medical device innovation.