Staff Engineer, Design Validation
About The Position
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.
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
- Experience within the medical device industry
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Miscellaneous Manufacturing
Number of Employees
5,001-10,000 employees
