Senior Product Safety Engineer

Stryker•Portage, MI
•$77,700 - $129,500•Hybrid

About The Position

Stryker is seeking a Senior Product Safety Engineer to help develop safe, high-quality medical devices. The role works with cross-functional teams and offers an opportunity to build expertise in product safety during medical device development. It supports the Product Engineering business unit within Stryker Instruments.

Requirements

  • Bachelor's degree in electrical engineering or a related discipline.
  • At least 2 years of work experience.

Nice To Haves

  • Working knowledge of electrical design processes, 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 the effects of design choices on the system.
  • Knowledge of IEC 60601-1 (Medical Electrical Equipment Safety).
  • Knowledge of IEC 60601-1-2 (Electromagnetic Compatibility).
  • Knowledge of IEC 60529 (Ingress Protection).
  • Knowledge of the IEC 61000 series (EMC Testing).
  • Knowledge of IEC 61010-1.
  • Knowledge of ISO 17025 laboratory requirements.
  • Knowledge of product safety certification processes and third-party testing organizations (NRTLs).

Responsibilities

  • Work with Research and Development teams to define and implement product safety program plans for large, complex development programs.
  • Create product safety test plans and ensure the plans can be completed and meet third-party certifier requirements for internal product safety testing.
  • Apply advanced circuit and electrical system test methods.
  • Conduct or design prototyping and bench testing.
  • Solve problems, identify potential solutions, and evaluate them against component and subsystem requirements.
  • Conduct research and studies to support product design.
  • Translate design inputs into engineering specifications and produce component- and subsystem-level designs.
  • Independently create or refine engineering documentation, such as the Design History file.
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