Medical Device Product Engineer - Design & Impact

OrganOx, Inc.; Madison (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision care

Disability coverage

401(k) retirement plan with company匹配

Paid time off

Holidays

Job summary

OrganOx, Inc. is expanding its Product Engineering team and seeking a Product Engineer to contribute to our existing product range.

You will support design changes, resolve manufacturing issues, and collaborate with Operations, Quality, and Development teams to transfer designs to production. The role requires experience with electro-mechanical devices, ability to design experiments, and strong technical reporting in English.

Qualifications

• Essential: Bachelor's degree in a relevant field; 5-7 years of experience in a similar role.
• Experience with electro-mechanical devices and designing/testing experimental plans.
• Ability to produce high-quality technical reports in English and manage multiple projects.

Responsibilities

• Contribute to design changes to support product, production, and quality improvements; perform root cause analysis.
• Investigate device performance issues with quality, service and operations teams; propose corrective actions.
• Interpret product intended use and customer needs; generate and refine engineering documentation (DHF, DMR).
• Follow R&D procedures, failure analysis, design controls, and risk management per ISO 13485 and SOPs.
• Assist prototyping, bench tests, and transfer of designs to production.

Skills

Product engineering

Electro-mechanical devices

Design of experiments

Technical reporting

Multi-disciplinary teamwork

Supplier collaboration

Project management

Education

Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering

Job description

OrganOx, Inc. is expanding its Product Engineering team and seeking a Product Engineer to contribute to our existing product range.

You will support design changes, resolve manufacturing issues, and collaborate with Operations, Quality, and Development teams to transfer designs to production. The role requires experience with electro-mechanical devices, ability to design experiments, and strong technical reporting in English.