R&D Engineering Manager
On-siteCharlotte, North Carolina, United States
Job Summary
Lead and mentor entry- to mid-level R&D engineers while driving the development of Class II and Class III interventional medical devices from concept through commercialization. Partner with cross-functional teams including Quality, Regulatory, Manufacturing, and Commercial to deliver compliant, manufacturable solutions and manage design transfer into production. Establish engineering priorities, allocate resources, and balance workloads across multiple customer development programs. Ensure all activities adhere to FDA regulations, ISO 13485, and Design Controls while leading root cause analysis, CAPAs, and continuous improvement initiatives. Build a high-performing organization that fosters technical excellence, collaboration, and customer responsiveness.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related engineering discipline
- 5+ years of progressive engineering experience in medical device product development
- 2+ years of engineering leadership, supervisory, or technical lead experience
- Experience developing Class II and/or Class III medical devices
- Proven experience leading new product development from concept through commercialization and design transfer into manufacturing
- Strong working knowledge of FDA Design Controls, ISO 13485, ISO 14971, verification and validation, and risk management
- I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities
- I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date
Desired Qualifications
- Master's degree
- Demonstrated experience with catheter-based, minimally invasive, or interventional medical devices
- Experience working directly with customers in a contract development and manufacturing (CDMO) environment
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