Senior Product Safety Engineer, Electrical
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Sr Product Safety Engineer, Electrical located in Kalamazoo, Michigan
Who we want:
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What You Will Do:
Work as a development partner with the product development groups, evaluate new products & existing product modifications to the applicable requirements of safety standards as relevant for the design of medical equipment.
- Work with New Product Development, Product Engineering and Operations teams to ensure compliance of our products to the global safety requirements.
- Support product development teams with the technical understanding of the required safety standards during the design & development of medical devices.
- Carry out design analysis to support the development of products within the boundaries of safety standards. Partner with R&D on identification, analysis, and implementation of design elements relevant for product safety.
- Understand and interpret IEC60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) and related standards.
- Conduct and coordinate safety testing, including EMI/EMC and Wireless, and evaluate test results.
- Conduct root cause analysis and implement due diligence actions to resolve product issues.
- Drive safety design reviews with the project teams
- Provide support to external test houses during product evaluations.
- Interact with outside agencies and support audits, as needed.
- Collaborate with other divisions, partner with R&D, other product development resources and external contractors locally and globally.
- Support Stryker's International Initiatives to launch products in Global Markets
- Serve as interface between development teams and CSA, UL, ETL, TUV and other regulatory agencies.
- Collaborate with Sales and Marketing teams as needed
- Maintain proficiency of worldwide safety regulations through research, development of the network, and ongoing education.
- Train in and obtain certification to perform testing to IEC 60601 series standards (Medical Electrical Equipment Safety), IEC 62133 (Lithium Ion Battery Safety) and others, as needed.
- Create and maintain appropriate reports and related documents.
What You Need:
- B.S. in Electrical Engineering, Biomedical Engineering, or related curriculum.
- 0-4 years of experience in Electrical or Bio-Electrical engineering
- Highly organized and capable of tracking multiple projects through various stages of development
- Being a resourceful, hands-on, problem -solving individual with initiative and drive to get things done.
- Strong technical leadership, communication, planning & organization skills with great work ethic.
- Experience with medical devices is very beneficial
- Working knowledge of regulations and standards related to Medical (60601) products is desired
- Experience in supporting internal and external audits is helpful.
- Good interpersonal communication skills.
- Must have the ability to work with and assemble small objects and component parts.
- Ability to operate common office equipment (e.g. calculator, PC, telephone, etc.) And common measuring devices (e.g. Micrometers, calipers, voltmeters, etc.).
- Must have good visual acuity and demonstrate fine motor skills.
- Must be able to generate, follow and explain detailed instructions and design parameters.
- Must be able to observe and correct minute inconsistencies (e.g. in the printed word, product appearance, etc.).
- Must be able to complete detailed documentation accurately.
- Must be able to analyze and correct complex product design issues of a moderate scope using independent judgment.
Work From Home: No
Travel Percentage: Up to 25%
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.
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