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Job Title:  Advanced Compliance Engineer

Req ID:  20944
Job Category:  Engineering
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

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.

What STERIS Offers

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

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STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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