REVA Medical

Position Summary

The Senior / Staff Process Development Engineer will lead development, characterization, validation, and implementation of laser cutting processes supporting REVA's bioresorbable scaffold platform.

This is a hands-on role responsible for process characterization, equipment qualification, process validation, supplier process development, manufacturing implementation, and regulatory submission support. The successful candidate will work closely with Manufacturing, Quality, Regulatory Affairs, R&D, and supplier partners to establish robust, scalable, and compliant manufacturing processes.

Please note: Relocation assistance and visa sponsorship are not available for this role.

Key Responsibilities

• Lead development, characterization, optimization, and validation of laser cutting processes for polymer medical devices.
• Develop and execute equipment qualifications, including IQ, OQ, and PQ protocols and reports.
• Design and execute process characterization studies, DOE activities, and process capability analyses.
• Develop manufacturing procedures, work instructions, process specifications, and inspection methods.
• Lead technical activities supporting regulatory submissions, including process characterization, validation, technical justifications, and responses to regulatory questions.
• Collaborate with equipment vendors and manufacturing partners to develop, optimize, and maintain manufacturing processes.
• Support supplier qualification, supplier process development, and manufacturing readiness activities.
• Troubleshoot manufacturing equipment and processes using data-driven problem-solving methods.
• Support risk assessments, change controls, investigations, CAPAs, and engineering studies.

Qualifications

• BS degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Materials Engineering, or related discipline.
• Senior Engineer: 5+ years of relevant experience.
• Staff Engineer: 10+ years of relevant experience preferred.
• Experience developing and validating manufacturing processes in a regulated industry, including IQ/OQ/PQ, DOE, and statistical analysis.
• Experience working with manufacturing equipment vendors and external suppliers.
• Medical device manufacturing experience preferred.
• Experience with laser cutting or laser processing technologies preferred.
• Hands-on experience developing or supporting laser cutting processes for stents, vascular scaffolds, hypotubes, polymer tubing, or other precision medical device components strongly preferred.
• Polymer processing experience preferred.
• Experience supporting FDA-regulated products preferred.

Work Environment

• Combination of office, laboratory, and manufacturing floor environments.
• Significant hands-on interaction with manufacturing equipment and process development activities.
• Must follow laboratory and manufacturing safety protocols and wear PPE as required.