Location: Onsite
Employment Type: Full-Time, Permanent

Overview

We are seeking a Process Development Engineer to support early-stage product development and drive the transition of new medical device designs into validated, manufacturing-ready processes. This role works closely with R&D, Manufacturing, and Quality to establish scalable, high-yield production processes.

Key Responsibilities

• Partner with R&D to translate design requirements into repeatable manufacturing processes

• Develop and mature processes from early development through pilot line and manufacturing transfer

• Design and specify production equipment, tooling, and fixtures

• Lead process characterization and yield improvement efforts

• Develop PFMEAs, process control strategies, and validation protocols

• Execute process validation activities (IQ/OQ/PQ)

• Train operators and support pilot line operations

• Own processes through stabilization and formal handoff to Manufacturing

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, or related)

• 5+ years of Process Development experience in medical devices

• Demonstrated experience bringing products from R&D into commercial manufacturing

• Strong understanding of design controls and validation requirements

• Hands-on experience with process characterization and optimization

Preferred Qualifications

• Catheter manufacturing experience

• Electromechanical process exposure

• Experience in small-to-mid-sized OEMs or CMOs