Principal Process Development Engineer

We are partnering with a growing medical device company seeking a Principal Process Development Engineer to support the development, optimization, and validation of manufacturing processes for a Class III implantable cardiovascular device.

This is a highly hands-on opportunity for someone with experience in tissue-based heart valves who enjoys solving complex manufacturing challenges and making critical decisions about implant quality. You'll play an important role in evaluating valve functionality, improving manufacturing processes, and helping scale production as the company advances toward commercialization.

Working closely with Operations, Quality, and Engineering, you'll have the opportunity to own meaningful process improvements while contributing to the development of life-changing medical technology.

Your Role with the Company:

• Evaluate tissue valve functionality, including leaflet opening, closing, and coaptation, to determine whether implants meet established acceptance criteria for human use.

• Lead manufacturing process development, optimization, and validation activities for tissue-based implantable devices.

• Troubleshoot manufacturing challenges, support final implant acceptance, and drive improvements in product quality and process yield.

• Develop and execute process validation activities, including IQ, OQ, PQ, process characterization, and MSA/Gage R&R.

• Design and improve manufacturing equipment, fixtures, inspection methods, and process controls.

• Identify opportunities to improve manufacturing efficiency, reduce scrap, and increase production capacity.

• Apply design-for-manufacturability principles to support process and product improvements.

• Develop and maintain manufacturing procedures, work instructions, and validation documentation.

• Collaborate with Operations, Quality, and Engineering to resolve technical challenges and ensure compliance with applicable quality and regulatory requirements.

Desired Profile:

• Bachelor's degree in Engineering or a related technical field.

• Minimum of 3 years of medical devices experience, specifically with tissue-based heart valves, including implant manufacturing and functional evaluation, is required.

• Hands-on experience evaluating implant functionality, troubleshooting manufacturing processes, and making product acceptance decisions.

• Experience with process development and validation, including IQ, OQ, PQ, process characterization, and Gage R&R.

• Experience improving manufacturing yield, developing fixtures or inspection methods, and supporting production scale-up is a plus.

• Strong problem-solving skills, attention to detail, and the ability to work independently while collaborating across functional teams.

• Comfortable working directly on the manufacturing floor and in a cleanroom environment.