Senior Engineer, R&D

Stryker•Mahwah, NJ
•Hybrid

About The Position

The Senior Engineer, R&D focuses on product sustainment, continuous improvement, design changes, and lifecycle management. The role applies engineering expertise across manufacturing, quality, regulatory, and testing functions to maintain product performance, support technical investigations, and implement engineering solutions throughout the product lifecycle. The position represents the R&D sustainment engineering team at the manufacturing site and coordinates technical activities with global engineering and manufacturing partners. It supports remediation, maintenance, and lifecycle management for customized implants within the CMF product portfolio, and leads the evaluation, development, and implementation of engineering and design changes using established change management processes. The role is hybrid in Mahwah, New Jersey, with 20% travel.

Requirements

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

Nice To Haves

  • 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.

Responsibilities

  • 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 for 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 to 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.
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