Staff Engineer, Design Validation (HYBRID)

Work Flexibility: Hybrid

What You Will Do

• 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.

What You Need (Required Qualifications)

• 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

Preferred Qualifications:

• 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.

Travel Percentage: 20%

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.