Staff Engineer, Design Validation
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Fort Lauderdale • Florida • United States
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Job Level
About the role
- Lead design validation activities including preparing stimulated use environments, participant recruitment, defining sample sizes and acceptance criteria for successful execution of clinical, customer-centric labs.
- Collaborate with cross-functional teams to develop high quality user needs and product requirements based on Regulatory strategy, Marketing inputs and applicable standards.
- Participate in various Usability and Human Factors activities to refine User Needs and validate all aspects of device design, packaging, labeling and training.
- Determine appropriate Design validation methods that are statistically significant, objective and clinically relevant for testing the Intended Use of the product and User Needs.
- Develop technical expertise in complex navigation and robotics-assisted orthopedic systems and apply in-depth knowledge of the operating room environment to inform test method development, data interpretation and evaluate product performance and risk.
- Use strong Systems Engineering principles and FDA Design Controls knowledge to drive best practices in User Needs, Requirements and V&V activities.
- Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry’s best practices.
Requirements
- Bachelor’s degree in Biomedical Engineering, Electronic/Electrical Engineering, Human Factors Engineering, or Lifesciences discipline
- 4+ years of industry experience validating complex hardware/ software or systems or performing Human Factors/Usability evaluations.
- Experience within the medical device industry
- Strong understanding of relevant medical device regulations and standards such as FDA Guidance documents, IEC 62366, 60601-1-6, HE75
- Experience in Customer-centric Design, User Needs Research, Accuracy Testing and working through different stages of med tech development.
- Background in Navigation, Robotic and complex software-based medical technologies.
- Strong collaborative and leadership skills, with the ability to work effectively with cross-functional teams.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
design validationUsability evaluationsHuman Factorsstatistical methodssystems engineeringFDA Design ControlsCustomer-centric DesignUser Needs ResearchAccuracy Testingrobotics-assisted orthopedic systems
Soft Skills
collaborative skillsleadership skillscross-functional teamwork