Senior R&D Engineer

We are constantly looking to add to our core talent. The Senior R&D Engineer role is responsible for lifecycle management of commercialized apheresis and plasmapheresis medical device disposables. The role 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.

Requirements

• Bachelor's degree in Biomedical, Mechanical, Materials, Chemical or Systems Engineering or combination of relevant education and experience required
• 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 and Medical device design history file (DHF) maintenance
• 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 Lean certification

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• Employee stock purchase plan
• Flexible time off for salaried employees
• Accrual of three to five weeks' vacation annually (based on tenure) for hourly employees
• Accrual of up to 64 hours (annually) of paid sick time
• Paid and/or floating holidays
• Parental leave
• Short- and long-term disability insurance
• Tuition reimbursement
• Health and welfare benefits