Senior Process Development Engineer - Medical Devices Equity

Shifamed; Los Gatos (CA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Akura Medical, a Shifamed portfolio company, seeks a Senior Process Development Engineer to advance manufacturing processes for vascular devices. You will work across functions to develop, verify, and validate new methods, and document progress through MPIs, qualifications, and validation reports.

The role requires 5–8 years in the medical device field, expertise in DFMEA, process validation, and SolidWorks CAD for fixture design. A cleanroom environment experience is preferred.

Qualifications

• Cross-functional collaboration to develop, verify and validate processes.
• Ability to design and fabricate assembly fixtures and manufacturing equipment.
• Experience with design for manufacturing and process development for stent manufacturing (laser cutting, shape setting, microblasting, electropolishing).
• Experience with quality systems and FDA/ISO regulations.

Responsibilities

• Provide creative solutions to satisfy unmet clinical needs through innovative manufacturing processes.
• Work with cross-functional teams to validate processes through bench, in-vitro, and in-vivo testing.
• Document work in lab notebooks, MPIs, equipment qualifications, and process validation.
• Research, develop, modify and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
• Support regulatory/clinical, marketing, and sales efforts with technical input.
• Lead risk management activities including FMEAs and CAPAs.
• Develop test protocols and write test reports for product verification and validation.
• Manage supplier selection and vendor relations.

Skills

Cross-functional teamwork

Statistical analysis

Problem solving

Regulatory awareness

Education

Bachelor's or Master's in Engineering

Tools

SolidWorks

Job description

Akura Medical, a Shifamed portfolio company, seeks a Senior Process Development Engineer to advance manufacturing processes for vascular devices. You will work across functions to develop, verify, and validate new methods, and document progress through MPIs, qualifications, and validation reports.

The role requires 5–8 years in the medical device field, expertise in DFMEA, process validation, and SolidWorks CAD for fixture design. A cleanroom environment experience is preferred.