If you are interested in a career that helps make it possible for doctors to perform life changing surgeries and impact the health and well being of surgical patients everywhere, then STERIS' Surgical Solutions team is the place for you. Our offering includes general and specialty surgical tables, surgical and examination lights, equipment management systems, operating room storage cabinets, warming cabinets, scrub sinks and other complementary products and accessories for use in hospitals and ambulatory surgery sites. The Advanced Compliance Engineer is a crucial role in the organization as the liaison between the the internal research and development engineering team and the external testing agencies to ensure products are designed according to industry standards and determine the full scope of external compliance testing required for the entire suite of products. This is a highly visible and highly collaborative position within Surgical Solutions that works across multiple cross functional teams.
What you will do
- The Advanced Compliance Engineer is responsible for safety and compliance of new medical device product introductions to applicable standards.
- Responsible for compliance planning and identifying budget and resource requirements.
- Ensure that product requirements, design inputs and design specifications accurately reflect industry and regulatory compliance requirements at the appropriate level of detail.
- Review and evaluate designs for R&D and obtains any needed standards interpretations or clarifications from certified national testing lags.
- Participate in or leads safety and compliance related activities.
- Facilitate evaluation and testing of new products to the appropriate standards, aids R&D in identifying and ensures non-compliance issues are mitigated.
- Lead product risk management activities and ensures product risk management files contains thorough, accurate, up-to-date risk assessments and hazard analysis documentation.
- Participates in HIPAA, GDPR and cybersecurity requirement evaluations during product risk assessments.
What you need to be successful
- Bachelor's Degree in Electrical, Mechanical, Biomedical, Systems or similar Engineering degree.
- 8+ years of experience in a medical device or regulated industry with a minimum of 5 years with a medical device company in a Compliance, Regulatory, or Quality capacity.
- 3+ years experience in a new product development environment.
- Detailed working knowledge of IEC 60601-1, IEC 60601-1-2 and ISO 14971 product safety standards.
- Strong written and verbal communication skills.
- Familiarity with IEC 60601 Particular Standards preferred. (ie: 60601-2-46, 60601-2-41)
- Experience applying risk management practices in compliance with ISO 14971 preferred.