Senior Engineer, R&D

The Senior Engineer, R&D 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. This role is Hybrid in Mahwah, NJ.

• 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.

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

• 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.

• US20
  : $93,200 - $155,400 USD Annual

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