Principal Implant Process Development Engineer
About The Position
The Principal Process Development Engineer supports the development, optimization, and validation of manufacturing processes for a transcatheter mitral valve replacement (TMVR) system. The role provides technical leadership in process engineering, equipment and fixture development, process validation, and manufacturing improvements in a fast-paced production environment. Working closely with Operations, Quality, and Engineering, the engineer helps ensure manufacturing processes are capable, repeatable, and compliant while improving product quality, yield, and operational efficiency. The position supports a medical device company developing a TMVR through pivotal clinical development and contributes to advancing the device toward commercialization.
Requirements
- Bachelor's degree in Engineering or a related technical field.
- At least 3 years of engineering experience within the medical device industry.
- Experience supporting manufacturing process development, optimization, troubleshooting, or validation.
- General knowledge of inspection and measurement equipment, such as laser micrometers, calipers, and drop gauges.
- Strong analytical, problem-solving, organizational, and time management skills.
- Excellent written and verbal communication skills.
- Ability to work independently, collaborate across functional teams, and adapt to changing priorities.
- Ability to work in a cleanroom environment and follow applicable safety, quality, and procedural requirements.
Nice To Haves
- Experience with process validation methodologies, including IQ, OQ, PQ, process characterization, and Gage R&R.
- Experience developing manufacturing fixtures, equipment, inspection methods, or process controls.
- Familiarity with manufacturing quality systems and applicable FDA and ISO requirements.
- Experience applying design-for-manufacturability principles and implementing yield, cost, or process efficiency improvements.
- Experience with implantable medical devices, cardiovascular devices, tissue-based products, or other highly regulated products.
- Demonstrated ownership, initiative, adaptability, collaboration, and commitment to continuous improvement.
Responsibilities
- Lead process development, optimization, and validation activities for TMVR implant manufacturing.
- Support final implant acceptance, troubleshoot manufacturing issues, and improve process yield and product quality.
- Serve as a core Operations team member in developing and executing master validation plans for implant manufacturing processes.
- Author and execute process validation protocols and reports, including Installation Qualification (IQ), Process Characterization, Measurement System Analysis (MSA/Gage R&R), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop and improve manufacturing processes, equipment, fixtures, and inspection methods.
- Apply design-for-manufacturability principles to evaluate and implement process and design alternatives.
- Develop and maintain manufacturing procedures, work instructions, and process documentation in accordance with quality system requirements.
- Identify and implement cost-saving and yield improvement opportunities, particularly in incoming tissue inspection and valve functional inspection.
- Evaluate and recommend technologies, materials, and equipment to improve existing and future manufacturing processes.
- Partner with Operations, Quality, and Engineering to resolve technical challenges and support project objectives.
- Maintain compliance with company policies, quality standards, cleanroom requirements, and applicable regulatory requirements.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
