Staff Engineer, Design Validation

Work Flexibility: Hybrid

What You Will Do:

• Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.
• Lead various design validation activities including preparing stimulated use environments, defining sample size and acceptance criteria, managing participant recruitment for Digital, Robotics and Enabling Tech products.
• Develop and validate all clinically relevant use cases for navigated and robotic orthopedic procedures by engaging with KOLs, observing clinical procedures, etc.
• Apply in-depth knowledge of the operating room environment and complex medical technology to perform clinically relevant design validation testing.
• Participate in various user-centric development activities and confirm user needs are met effectively in all aspects of device design, packaging, labeling and training.
• Use strong Systems Engineering Principles to drive best practices in User Needs, Requirements, and V&V activities.
• Collaborate with various cross-functional teams such as Medical Education and Marketing to mimic field-training in support of successful medical device launch.
• Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry's best practices.

What You Will 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
• 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 User Needs Research, Design validation, and med tech product development.
• Excellent problem-solving, analytical and communication skills.
• 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.