Senior R&D Engineer

Position Summary

The role of the Senior R&D Engineer requires an experienced leader with skills in problem‑solving, stakeholder management, communication, and aligned autonomy. It is a “role‑modeling” position that demands not only expertise in execution, but strategic leadership skills.

This Senior R&D Engineer role is responsible for lifecycle management of commercialized apheresis and plasmapheresis medical device disposables. It leads sustaining engineering activities including CAPA ownership, investigations, design change management, and technical support for commercial, quality, and operational initiatives, while maintaining compliance with design control and regulatory requirements.

This position may also act as the Product Design Owner (PDO) for assigned products, representing the product's design history during internal audits, regulatory inspections, and notified body audits. The role partners with Quality, Regulatory, and Operations to ensure safe, compliant, and reliable products throughout their lifecycle.

• Lead technical support and lifecycle management for commercialized Apheresis and Plasmapheresis medical device disposables
• Lead technical support and lifecycle management for commercialized medical device disposables
• Investigate and resolve design product performance issues, complaints, and manufacturing nonconformances
• Identify opportunities to improve product reliability, manufacturability, quality, and cost
• Maintain design documentation and ensure ongoing compliance with design control requirements
• Mentor, train, and coach junior engineers
• Ability to travel to internal, supplier and customer facilities

• Lead and support Corrective and Preventive Action (CAPA) investigations related to product design: including complaints, quality issues, and field performance
• Conduct root cause analysis using structured methodologies (e.g., 5 Whys, Ishikawa, Fault Tree Analysis)
• Define and implement Corrective and Preventive actions with cross‑functional teams
• Ensure CAPA documentation is thorough, timely, and compliant within quality system requirements

• Lead design change activities for sustaining products, including Engineering Change Orders (ECO)
• Evaluate impact of design changes on:
  • Risk management files
  • Verification and validation requirements
  • Regulatory submissions
  • Manufacturing processes and suppliers
• Execute design verification/validation activities required to support product modifications
• Ensure all design changes follow formal design control and change management processes

• Serve as Product Design Owner (PDO) for assigned medical disposable products
• Represent the product design during internal audits, regulatory inspections, and notified body audits
• Present and defend design decisions using Design History File (DHF) documentation
• Ensure documentation readiness and traceability across the product lifecycle

• Bachelor's degree in Biomedical, Mechanical, Materials, Chemical or Systems Engineering or combination of relevant education and experience required
• Master's degree in Biomedical, Mechanical, Materials, Chemical or Systems Engineering or combination of relevant education and experience preferred

• 5+ years of engineering experience in the medical device industry.
• Demonstrated experience supporting sustaining engineering or post‑launch product lifecycle management.
• Direct experience with:
  • CAPA investigations
  • Root cause analysis
  • Design change implementation
  • Design controls and DHF management

• Strong knowledge of ISO 13485 Quality Management Systems
• QMSR / FDA 21 CFR 820 Design Controls
• ISO 14971 Risk Management
• Medical device design history file (DHF) maintenance
• Verification & validation practices for design changes

• Experience working with disposable medical device technologies (e.g., injection molded components, tubing, assemblies, sterilization, packaging)
• Experience representing products during FDA or notified body audits
• Experience supporting sterilized, single‑use medical devices
• Six Sigma or…