Principal Implant Process Development Engineer

Description

WHO WE ARE

We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a transcatheter mitral valve replacement through pivotal clinical development, with a shared commitment to bringing safe, effective, and innovative technology to patients.

THE OPPORTUNITY

The Principal Process Development Engineer will support the development, optimization, and validation of manufacturing processes for our transcatheter mitral valve replacement (TMVR) system. This role provides technical leadership in process engineering, equipment and fixture development, process validation, and manufacturing improvements to support a fast-paced production environment.

Working closely with Operations, Quality, and Engineering, this individual will help ensure manufacturing processes are capable, repeatable, and compliant while driving improvements in product quality, yield, and operational efficiency.

HOW YOU WILL CONTRIBUTE

• Lead process development, optimization, and validation activities supporting TMVR implant manufacturing.
• Support final implant acceptance, troubleshoot manufacturing issues, and drive improvements in 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 new technologies, materials, and equipment to improve existing and future manufacturing processes.
• Partner cross-functionally 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.

WHY JOIN US

• Contribute directly to the development and manufacturing of innovative technology designed to improve patient outcomes.
• Play an important role in advancing a novel structural heart device from clinical development toward commercialization.
• Take ownership of meaningful process development and validation initiatives.
• Work alongside a collaborative, multidisciplinary team in a growing medical device organization.
• Help build and improve manufacturing processes as the company scales.

Requirements

WHAT YOU NEED TO SUCCEED (MINIMUM QUALIFICATIONS)

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

WHAT WILL SET YOU APART (COMPETENCIES)

• 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 working with implantable medical devices, cardiovascular devices, tissue-based products, or other highly regulated products.
• Demonstrated ownership, initiative, adaptability, collaboration, and commitment to continuous improvement.

Working Conditions: Primarily office- and manufacturing-based, with the ability to work in a cleanroom environment. May require occasional travel up to 5% and extended hours during peak periods to support manufacturing and project needs. Ability to sit or stand for extended periods and lift up to 20 pounds as needed.