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Inari Medical

Senior Manufacturing Engineer

Posted 3 Days Ago
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In-Office
Irvine, CA, USA
89K-149K Annually
Senior level
In-Office
Irvine, CA, USA
89K-149K Annually
Senior level
Designs, validates, troubleshoots, and improves manufacturing processes, equipment, tooling, and fixtures for medical devices. Supports production quality, safety, compliance, experiments, risk management, design controls, supplier collaboration, and engineering projects. Trains operators on process changes and partners with cross-functional teams to resolve manufacturing issues and optimize performance.
The summary above was generated by AI
Work Flexibility: Onsite

What You Will Do

  • Support the ongoing manufacturing of medical devices by designing, documenting, and improving manufacturing processes and operations that ensure product safety, quality, and performance.
  • Train operators on new revisions of documents released through change order management process.
  • Execute validation activities for new equipment.
  • Analyze, troubleshoot, and resolve manufacturing issues impacting product quality, safety, delivery, or cost.
  • Design, develop, and implement manufacturing equipment, tooling, and fixtures to support production requirements.
  • Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
  • Support product development and sustaining engineering activities through technology development, specification creation, process studies, material testing, and technical reporting.
  • Participate in risk management and design control activities, including FMEA and design reviews.
  • Partner with operators, technicians, production supervisors, quality engineers, and cross-functional teams to address production floor challenges and improve manufacturing performance.
  • Manage engineering project activities including planning, documentation, scheduling, progress tracking, and implementation.
  • Evaluate and implement process or product alternatives to optimize manufacturing performance.
  • Collaborate with suppliers and external partners to support equipment, process, and product initiatives.
  • Champion patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.

What You Need

Required Qualifications

  • Bachelor's degree in Engineering.
  • 2+ years of relevant experience supporting manufacturing processes and operations in a production environment.
  • Experience conducting process, equipment, or product qualification, verification, and validation activities.
  • Experience troubleshooting manufacturing, process, or quality-related issues and implementing effective solutions.
  • Experience designing, developing, or supporting manufacturing equipment, tooling, and fixtures.
  • Ability to create, read, and interpret engineering drawings using standard engineering software.
  • Strong analytical and problem-solving skills, including statistical, geometric, and mathematical analysis.
  • Ability to manage technical responsibilities with limited supervision.

Preferred Qualifications

  • Experience within the medical device industry or another regulated manufacturing environment.
  • Experience supporting packaging work center.
  • Proficiency with Minitab or similar statistical software.
  • Experience participating in design control activities, including risk analysis and FMEA.
  • Experience selecting suppliers and assessing supplier capabilities and performance.
  • Experience supporting materials testing, process studies, and manufacturing investigations.

  


$89,400 - $148,900 USD Annual

  


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. 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.
HQ

Inari Medical Irvine, California, USA Office

6001 Oak Canyon, Suite 100, Irvine, CA, United States, 92618

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