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 and EU MDR, 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.