SeniorStaff Process Development Engineer Laser Manufacturing

Position Summary

The Senior / Staff Process Development Engineer will lead development characterization validation and implementation of laser cutting processes supporting REVAs 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.

Required Experience:

Staff IC