Senior/Staff Process Development Engineer - Laser Manufacturing

Senior/Staff Process Development Engineer - Laser Manufacturing REVA Medical, LLC San Diego, CA Job Details Full-time $150,000 - $195,000 a year 15 hours ago Benefits Relocation assistance Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications FDA submissions Bachelor's degree in mechanical engineering Polymers experience in materials engineering Production data analysis Procedural guides Laser cutting 5 years Quality control statistical data analysis Bachelor of Science Preventive action implementation Design of manufacturing processes Engineering Design of experiments Bachelor's degree in biomedical engineering Mechanical Engineering Machine troubleshooting CNC laser cutting Engineering process optimization Biomedical Engineering Corrective and preventive actions (CAPA) Personal protective equipment (PPE) adherence Industrial equipment troubleshooting Factory operations documentation Manufacturing standard operating procedures Manufacturing facility Statistical analysis Policy & process development Production validation processes Medical device manufacturing facility experience Materials Engineering Full Job Description 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.