Medical Device Product Engineer - Impact & Innovation

OrganOx Limited; Madison (NJ); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, dental, vision

401(k) with company matching

Paid time off

Holidays and additional leave

Onsite wellness facility

Employee discounts

Job summary

OrganOx is expanding its engineering capability and seeking a Product Engineer to join the Product Engineering team. You will work in a small, multi-disciplinary group focusing on the existing product range, implementing design changes, verification, and feature expansion.

The role involves close collaboration with operations, quality, and development teams to resolve obsolescence, transfer designs to production, and support design reviews and design transfer activities.

Qualifications

• Bachelor's degree or equivalent in CS, SWE, Biomedical Engineering, or related field.
• 5–7 years of experience in a similar product engineering role.
• Experience with electro-mechanical devices and safe operation of devices.
• Excellent written and verbal English communication.
• Ability to work in a multi-disciplinary team and with outside suppliers.
• Understanding of ISO 13485 quality management system and documentation practices.
• Experience with design changes, documentation and validation processes.

Responsibilities

• Contribute to design changes to support product, production and quality improvements.
• Investigate device performance issues and recommend corrective actions.
• Interpret product use, clinical procedures, and customer needs.
• Create/refine engineering documentation such as DHF and DMR.
• Follow and contribute to R&D procedures (failure analysis, design controls, risk management).
• Assist prototyping and bench testing.
• Prepare reports and conclusions for presentation.
• Ensure documentation conforms to ISO 13485 and local procedures.

Skills

Product Engineering

Electro-mechanical devices

Test planning

Technical writing

Cross-functional teamwork

Supplier collaboration

Project management

Education

Bachelor's degree or equivalent in CS/Software Engineering/Biomedical Engineering

Job description

OrganOx is expanding its engineering capability and seeking a Product Engineer to join the Product Engineering team. You will work in a small, multi-disciplinary group focusing on the existing product range, implementing design changes, verification, and feature expansion.

The role involves close collaboration with operations, quality, and development teams to resolve obsolescence, transfer designs to production, and support design reviews and design transfer activities.