Senior Product Safety Engineer
$77.7k - $129.5kStryker Orthopaedics
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
$77.7k - $129.5k
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