Stryker Corporation

Senior Manufacturing Engineer

Stryker Corporation$101K — $168K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 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

Responsibilities

  • Design, develop, and validate manufacturing processes (IQ/OQ/PQ) for 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
  • Apply Lean and Six Sigma methodologies to enhance efficiency and reduce defects
  • Collaborate with R&D on design-for-manufacturability during product development
  • Define equipment specifications and oversee procurement and commissioning
  • Maintain compliance with FDA, ISO 13485, and ISO 14971 requirements

Benefits

  • Work flexibility with an onsite requirement in Ventura, California
  • Support for continuing education and potential certification opportunities
  • Collaborative work environment with R&D, Regulatory Affairs, and Quality teams
  • Focus on innovation in the medical device field
  • Participation in audits and inspections to maintain high-quality standards
Full Job Description
Work Flexibility: Onsite

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

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
  • Collaboration 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


United States of America Pay Ranges:
  • US10: $101,000 - $168,400 USD Annual 85,500.00 - 114,000.00 - 142,500.00 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 10%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ

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