Senior Manufacturing Engineer

Onsite Senior Manufacturing Engineer, Ventura, California

Onsite Senior Manufacturing Engineer in Ventura, California leads and coordinates the fabrication, installation, operation, maintenance, and repair of mechanical and electromechanical manufacturing systems. The role ensures quality and industry standards are consistently met or improved while driving efficiency, evaluating equipment performance, cost-effectiveness, and recommending design or process modifications to enhance reliability and reduce malfunctions.

• 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) and prepare responses to audit findings.
• Maintain compliance with FDA, ISO 13485, and ISO 14971 requirements.

• 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).
• Preferred:
  Six Sigma Green Belt or Black Belt certification.
• Preferred:
  Experience supporting Class II or Class III medical devices.
• Preferred:
  Familiarity with ISO 14971 risk management and FMEA methodologies.
• Preferred:
  Proficiency with CAD tools (e.g., Solid Works) and ERP/MES systems.
• Preferred:
  Experience supporting FDA inspections or Notified Body audits.
• Preferred:
  Knowledge of sterilization methods (EtO, gamma, e‑beam) or cleanroom manufacturing.

Pay range: US10: $101,000 - $168,400 USD Annual; 85,500.

-  USD Annual. Travel: 10%.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.