Stryker

Stryker

Sr. Manufacturing Engineer

Ventura, California · Senior · Contract

Sponsorship not specified$86k-$143kDetected 5 days ago
StatisticsProcess ImprovementProcurementERPSolidWorksMechanical DesignFDA RegulatoryMedical DevicesCollaborationRegulatory Affairs

About the role

  • This is an onsite role in Ventura, California.
  • Travel Percentage: 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.

Responsibilities

  • Develop and maintain process FMEAs, control plans, and work instructions
  • Lead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformances
  • Partner with R&D to ensure design-for-manufacturability (DFM) during new product development and Design Transfer activities
  • lead procurement, installation, and commissioning of manufacturing equipment
  • Maintain calibration and preventive maintenance programs for production equipment
  • Support internal, customer, and regulatory audits (FDA, Notified Body)
  • Maintain compliance with FDA, ISO 13485, and ISO 14971 requirement
  • Define equipment specifications; lead procurement, installation, and commissioning of manufacturing equipment
  • Support internal, customer, and regulatory audits (FDA, Notified Body); prepare responses to audit findings

Requirements

  • Bachelor's degree in Mechanical engineering, Biomedical Engineering, Industrial Engineering, or related discipline
  • Hands-on experience with process validation (IQ/OQ/PQ) and Design Transfer
  • Proficiency with statistical analysis and process capability tools (e.g., Cpk, Gage R&R)
  • Master's degree in Engineering (Mechanical, Biomedical, Industrial, or related field)
  • Proficiency with CAD tools (e.g., SolidWorks) and ERP/MES systems

Compensation

  • $85,500 - $142,500 USD Annual
  • View the U.S. work location and transparency guide to find the pay range for your location.

Benefits

  • Design, develop, and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product lines
  • Minimum 5 years of engineering experience in a regulated medical device manufacturing environment
  • Experience supporting Class II or Class III medical devices
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This listing is sourced directly from Stryker's careers page and normalized into a canonical job model.