Product Engineer

Responsibilities

• Support the implementation and verification of design changes to introduce new features and drive continuous improvement.
• Work closely with operations to resolve component obsolescence, manufacturing issues, or product complaints.
• Create and refine engineering documentation, including Design History Files (DHF) and Device Master Records (DMR).
• Conduct problem-solving efforts and root cause analysis to investigate device performance issues.
• Support the creation of assembly and test instructions for the operations team and suppliers.
• Assist with prototyping efforts, bench testing, and design transfer activities.
• Ensure all activities and documentation comply with ISO 13485 and local regulatory procedures.

Requirements

• Degree in Electronic, Mechanical, Biomedical, or general engineering.
• Demonstrable experience in Product Engineering or Product Development, preferably within the medical device industry.
• Experience working with electro-mechanical devices, including troubleshooting and interfacing.
• Ability to design, implement, and execute experimental test plans for safety-critical systems and fluid components.
• Strong technical writing skills for producing high-quality reports and documentation.
• Knowledge of ISO 13485 Quality Management Systems.
• Ability to work effectively within a multi-disciplinary team and manage multiple projects simultaneously.

Benefits

• Competitive compensation and comprehensive benefits available from day one.
• Health, dental, vision, and disability coverage.
• 401(k) retirement plan with company matching after 90 days.
• Paid time off, holidays, and additional leave benefits.
• Employee discounts and access to an onsite wellness facility.
• Opportunities for ongoing professional development.

About the Company

OrganOx is a commercial-stage organ technology company dedicated to improving outcomes for patients with acute or chronic organ failure. A pioneer in normothermic machine perfusion (NMP), OrganOx's flagship metra® platform is used globally to keep donor livers metabolically active outside the body, increasing the number of organs available for transplant. As part of the Terumo Group, we strive to contribute to society through healthcare innovation.