Senior Manufacturing Engineer
Irvine 6001 Oak Canyon STE 100, California
$89,400 - $148,900 per year
Posted 1 month ago
About the role
Work Flexibility: Onsite
What You Will Do:
- Design, develop, document, and continuously improve manufacturing processes and operations that ensure the safety, quality, and performance of medical devices.
- Design, procure, and oversee fabrication of tooling, fixtures, and manufacturing equipment in compliance with applicable safety requirements.
- Lead equipment and process qualification, verification, and validation activities for medical device manufacturing.
- Troubleshoot and resolve manufacturing issues related to safety, quality, delivery, productivity, and cost.
- Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
- Support new product development and product sustaining efforts through technology development, process studies, specification development, process improvements, and technical reporting.
- Participate in design control activities including risk assessments (FMEA), design reviews, and change management initiatives.
- Collaborate with operators, technicians, supervisors, engineers, and cross-functional teams to improve manufacturing performance and resolve production challenges.
- Develop, validate, and implement manufacturing equipment and processes while evaluating opportunities for continuous improvement.
- Support production goals through project planning, scheduling, execution, and documentation.
- Train and provide technical guidance to operators and technicians.
- Coordinate with suppliers and external partners to support process and product improvement initiatives.
- Analyze statistical data to identify trends, improve processes, and support business decisions.
- Demonstrate a commitment to 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 Mechanical Engineering.
- 2+ years of engineering experience in a manufacturing environment.
- Experience designing and developing tooling and fixtures for manufacturing applications.
- Experience creating, reading, and interpreting engineering drawings using SolidWorks or other engineering design software.
- Ability to perform statistical, geometric, and mathematical analyses to solve technical problems.
- Experience supporting equipment and process validation activities.
- Strong troubleshooting and root cause analysis skills in a manufacturing environment.
- Strong collaboration and communication skills with the ability to work effectively in a team environment.
Preferred Qualifications
- Experience in a regulated industry such as medical device manufacturing.
- Proficiency with Minitab or similar statistical analysis software.Knowledge of Controls Engineering, PLCs, HMIs, sensors
- Experience with Six Sigma, process improvement, and manufacturing optimization initiatives.
- Experience sourcing and managing suppliers, components, and external service providers.
- Experience supporting new product introduction and manufacturing scale-up activities.
$89,400 - $148,900 USD Annual
Travel Percentage: 0%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.About this listing
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