Product Safety Engineer

Stryker; Portage (MI); On-site; USD 70,000 - 111,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Critical illness insurance

Accident insurance

Hospital indemnity insurance

HSA

FSA

401(k) plan

ESPP

Life and AD&D insurance

Short-term disability insurance

Wellbeing program

Tobacco cessation program

Job summary

Stryker is seeking an early-career Product Safety Engineer focused on developing safe, high-quality medical devices. You will work with R&D teams to define and implement product safety program plans for large development programs within the Product Engineering unit of Stryker Instruments.

The role involves creating safety test plans, applying advanced circuit/test methods, prototyping and bench testing, and translating design inputs into engineering specifications.

Qualifications

• Bachelor's degree in EE or related discipline.
• 0+ years of work experience.
• Ability to interpret, analyze, and test electrical designs.
• Familiarity with electrical design processes and manufacturing methods.

Responsibilities

• Define and implement product safety program plans for large development programs.
• Create product safety test plans meeting third-party certifier requirements.
• Apply advanced circuit and electrical system test methods.
• Conduct prototyping and bench testing.
• Identify solutions by evaluating designs against requirements.
• Support product design with research and studies.
• Translate design inputs to engineering specifications and produce subsystem designs.
• Prepare or refine engineering documentation such as the Design History File.

Skills

Electrical design knowledge

Test methods

Cross-functional collaboration

Problem solving

Documentation drafting

Education

Bachelor's degree in EE or related discipline

Tools

CAD/CAE/simulation tools

Statistical analysis tools

Job description

Stryker is seeking an early-career 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 0+ 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)

$69,500 - $110,900 USD Annual

Health benefits include:

• Medical and prescription drug insurance
• dental insurance
• vision insurance
• critical illness insurance
• accident insurance
• hospital indemnity insurance
• personalized healthcare support
• wellbeing program
• tobacco cessation program

Financial benefits include:

• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• basic life and AD&D insurance
• short-term disability insurance

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes.

Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.