Senior Medical Device Manufacturing Engineer

Stryker; Ventura (CA); On-site; USD 85,500 - 142,500; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Job summary

Stryker in Ventura, CA is seeking a Senior Manufacturing Engineer to design, develop, and validate manufacturing processes for medical devices. You will lead qualification activities (IQ/OQ/PQ), process validation, DFx, and transfer to manufacturing, while ensuring compliance with FDA and ISO 13485.

The role requires collaboration with R&D, Regulatory, and Quality, plus experience with calibration, maintenance, and audits. A strong background in Lean and process capability tools is essential.

Qualifications

• Bachelor's degree in a related engineering field and 5+ years in regulated medical device manufacturing.
• Hands-on experience with IQ/OQ/PQ, Design Transfer, and validation protocols.
• Working knowledge of ISO 13485 quality systems.
• Proficiency with statistical tools (Cpk, Gage R&R) and process capability.
• Experience authoring SOPs, work instructions, and validation protocols.

Responsibilities

• Design, develop, and validate manufacturing processes (IQ/OQ/PQ) for medical devices.
• Develop and maintain process FMEAs, control plans, and work instructions.
• Lead RCA and CAPA investigations for nonconformances.
• Apply Lean and Six Sigma to reduce defects, cycle time, and costs.
• Partner with R&D for DFM during new product development and Design Transfer.
• Collaborate with Regulatory and Quality on technical files.
• Define equipment specifications; lead procurement, installation, and commissioning.
• Maintain calibration and preventive maintenance programs.
• Ensure DHR, DMR, and batch records are inspection-ready.
• Support FDA/Notified Body audits and respond to findings.
• Maintain compliance with FDA, ISO 13485, and ISO 14971.

Skills

Process validation (IQ/OQ/PQ)

Design Transfer

ISO 13485

Statistical analysis (Cpk, Gage R&R)

Engineering documentation (SOPs, work‑

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Industrial Engineering

Master’s degree in Engineering

Tools

SolidWorks

ERP/MES systems

Job description

Stryker in Ventura, CA is seeking a Senior Manufacturing Engineer to design, develop, and validate manufacturing processes for medical devices. You will lead qualification activities (IQ/OQ/PQ), process validation, DFx, and transfer to manufacturing, while ensuring compliance with FDA and ISO 13485.

The role requires collaboration with R&D, Regulatory, and Quality, plus experience with calibration, maintenance, and audits. A strong background in Lean and process capability tools is essential.