Senior Engineer, R&D

Senior Engineer, Research & Development  

Mahwah, NJ

This role focuses on product sustainment, continuous improvement, design changes, and lifecycle management, providing the opportunity to apply engineering expertise across manufacturing, quality, regulatory, and testing functions. You will play a key role in maintaining product performance, supporting technical investigations, and implementing engineering solutions throughout the product lifecycle.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Mahwah, NJ and be able to work onsite several days per week.

What You Will Do

• Represent the R&D sustainment engineering team at the manufacturing site and coordinate technical activities with global engineering and manufacturing partners.
• Support product remediation, maintenance, and lifecycle management activities around customized implants within the CMF product portfolio.
• Lead the evaluation, development, and implementation of engineering and design changes through established change management processes.
• Develop and implement engineering solutions that enhance product performance, manufacturability, reliability, and ongoing product support.
• Assess the impact of design changes on product performance, quality requirements, manufacturing processes, and regulatory compliance.
• Conduct technical investigations of customer complaints, nonconformities, and product-related issues using structured root cause analysis methodologies.
• Define, document, and implement corrective and preventive actions to address identified issues and support product reliability.
• Create, review, and maintain engineering documentation, technical specifications, risk management files, and design change records in compliance with applicable requirements.

What You Will Need

Required Qualifications

• Bachelor’s degree in Engineering or related discipline.
• Minimum 2 years of engineering experience.
• Experience conducting technical investigations and root cause analyses.
• Experience creating, reviewing, and maintaining engineering documentation and design change records.

Preferred Qualifications

• Experience working in the medical device industry.
• Experience supporting sustaining engineering, product maintenance, or product lifecycle management activities.
• Experience implementing product changes within a regulated quality management system.
• Experience collaborating with Quality, Manufacturing, Regulatory Affairs, or Testing functions.
• German language proficiency.