Sr. 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

Senior Manufacturing Engineer

Location: Ventura, California (onsite).

What You Will Do

• Design, develop, and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product lines.
• Develop and maintain process FMEAs, control plans, and work instructions.
• Lead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformances.
• Apply Lean and Six Sigma methodologies to reduce defects, cycle time, and manufacturing costs.
• Partner with R&D to ensure design‑for‑manufacturability (DFM) during new product development and Design Transfer activities.
• Collaborate with Regulatory Affairs and Quality on technical files.
• Define equipment specifications; lead procurement, installation, and commissioning of manufacturing equipment.
• Maintain calibration and preventive maintenance programs for production equipment.
• Ensure manufacturing documentation (DHR, DMR, batch records) is complete, accurate, and inspection‑ready.
• Support internal, customer, and regulatory audits (FDA, Notified Body); prepare responses to audit findings.
• Maintain compliance with FDA, ISO 13485, and ISO 14971 requirements.

What You Need

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related discipline.
• Minimum 5 years of engineering experience in a regulated medical device manufacturing environment.
• Hands‑on experience with process validation (IQ/OQ/PQ) and Design Transfer.
• Working knowledge of ISO 13485 quality management systems.
• Proficiency with statistical analysis and process capability tools (e.g., Cpk, Gage R&R).
• Experience authoring engineering documentation, including SOPs, work instructions, and validation protocols.

Preferred

• Master’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field).
• Six Sigma Green Belt or Black Belt certification.
• Experience supporting Class II or Class III medical devices.
• Familiarity with ISO 14971 risk management and FMEA methodologies.
• Proficiency with CAD tools (e.g., SolidWorks) and ERP/MES systems.
• Experience supporting FDA inspections or Notified Body audits.
• Knowledge of sterilization methods (EtO, gamma, e‑beam) or cleanroom manufacturing.

US Pay Ranges

• USD $85,500 – $142,500 Annually

Benefits

Health benefits include medical, prescription drug, dental, vision, critical illness, accident, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program. Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance.

Vaccination requirements may apply as an essential function for sales and field roles based on customer requirements.