Staff Engineer, Design Validation

What You Will Do:

n
• n

  Collaborate with cross-functional teams to develop the best in-class user needs that drive objective validation studies.

  n
n
• n

  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.

  n
n
• n

  Develop and validate all clinically relevant use cases for navigated and robotic orthopedic procedures by engaging with KOLs, observing clinical procedures, etc.

  n
n
• n

  Apply in-depth knowledge of the operating room environment and complex medical technology to perform clinically relevant design validation testing.

  n
n
• n

  Participate in various user-centric development activities and confirm user needs are met effectively in all aspects of device design, packaging, labeling and training.

  n
n
• n

  Use strong Systems Engineering Principles to drive best practices in User Needs, Requirements, and V&V activities.

  n
n
• n

  Collaborate with various cross-functional teams such as Medical Education and Marketing to mimic field-training in support of successful medical device launch.

  n
n
• n

  Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry's best practices.

  n
n

What You Will Need:

Required Qualifications:

n
• n

  Bachelor's degree in Biomedical Engineering, Electronic/Electrical Engineering, Human Factors Engineering, or Lifesciences discipline

  n
n
• n

  4+ years of industry experience validating complex hardware/ software or systems

  n
n
• n

  Experience within the medical device industry

  n
n

Preferred Qualifications:

n
• n

  Strong understanding of relevant medical device regulations and standards such as FDA Guidance documents, IEC 62366, 60601-1-6, HE75

  n
n
• n

  Experience in User Needs Research, Design validation, and med tech product development.

  n
n
• n

  Excellent problem-solving, analytical and communication skills.

  n
n
• n

  Strong collaborative and leadership skills, with the ability to work effectively with cross-functional teams.

  n
n

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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.