Senior Product Safety Engineer

Stryker Corporation; Portage (MI); Hybrid; USD 78,000 - 130,000; Full time

Job summary

Stryker Corporation in Portage, MI seeks a Senior Product Safety Engineer to lead safety programs for large, complex medical device development within the Product Engineering unit. You will define and implement product safety test plans, translate inputs into specifications, and collaborate with R&D to ensure regulatory compliance and high-quality outcomes.

This hybrid role requires a Bachelor’s degree in EE or related field and 2+ years’ experience, plus knowledge of IEC 60601‑1/2, EMC, and

Qualifications

• Bachelor’s degree in EE or related discipline.
• 2+ years of work experience.
• Ability to work with cross-functional teams.

Responsibilities

• Define and implement product safety test plans for large, complex development programs.
• Translate design inputs to engineering specifications and produce sub-system level designs.
• Collaborate with R&D to ensure regulatory compliance and safety.
• Apply advanced circuit and electrical system test methods and bench testing.
• Create or refine engineering documentation such as the Design History File.
• Support third-party certifiers and internal product safety testing requirements.

Skills

Product safety program development

Cross-functional collaboration

Test planning

Design inputs to specs

Regulatory awareness

Education

Bachelor’s degree in EE or related discipline

Tools

CAD/CAE/simulation tools

Job description

Senior Product Safety Engineer

Work Flexibility: Hybrid Stryker is seeking a Senior Product Safety Engineer who is passionate about developing safe, high-quality medical devices, enjoys solving technical problems while collaborating with cross-functional teams. This role offers an opportunity to build expertise in product safety during medical device development.

What You Will Do:

• Work with Research and Development (R&D) teams to define and implement a product safety program plans for large, complex development programs for the Product Engineering business unit within Stryker Instruments.
• Creates product safety test plans and ensures that the plans can be completed and meet the needs of 3rd party certifier's requirements with respect to our internal product safety testing.
• Apply advanced circuit and electrical system test methods
• Conduct or design prototyping and bench testing
• Conduct problem solving, identify potential solutions, and evaluate them against component and sub-system requirements
• Conduct research and studies to support product design
• Translate design inputs to engineering specifications and produce component and sub-system level designs
• Independently create or refine engineering documentation, such as the Design History file

What You Need (Required Qualifications):

Bachelor's degree in EE or related discipline and 2+ years of work experience

Preferred Qualifications (Strongly Desired):

• Working knowledge of electrical design process, electrical components, and manufacturing methods
• Ability to interpret, analyze, and test electrical designs
• Proficiency with design and concept generation CAD, CAE, or simulation tools
• Ability to apply analysis tools and statistical methods
• Knowledge of system components and associated requirements
• Understanding of the system lifecycle and effects of design choices on the system
• IEC 60601-1 (Medical Electrical Equipment Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• IEC 60529 (Ingress Protection)
• IEC 61000 Series (EMC Testing)
• IEC 61010-1 ISO 17025 laboratory requirements
• Product safety certification processes and third-party testing organizations (NRTLs)

$77,700 - $129,500 USD Annual Travel Percentage: None

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.

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.