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Job Title:  Senior Compliance Engineer

Req ID:  30898
Job Category:  Engineering

Cleveland, OH, US, 44124

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 Senior 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. 

*This position is located in Mentor, Ohio and requires weekly hours in the office.  It is eligible for a hybrid work option.

Duties

  • Responsible for planning the compliance activities of the New Product Development (NPD) project.  Planning includes identification of deliverables, budget and resource requirements and schedule requirements.  Coordinates with the Program Manager to ensure plans are integrated into the complete NPD Program Plan.
  • Ensures that in the planning phase the NPD Project Team identifies all applicable compliance standards.  Also ensures that compliance requirements are adequately represented in the product requirements and design specifications, with the appropriate level of detail.  Ensures that acceptance criteria are identified and are appropriate.
  • Supports R&D engineers by reviewing and evaluating designs for compliance with standards.  Obtains any needed standards interpretations or clarifications from the appropriate subject matter experts, test agencies or regulatory bodies.
  • The Senior Compliance Engineer may participate in or lead compliance related activities such as risk management, usability, test design and protocol development.
  • Facilitates evaluation and testing of new products to the appropriate standards by internal test engineers and technicians as well as external test agencies.  Acts as the liaison between R&D and external test agencies.
  • Provides assistance to R&D in identifying and resolving non-compliance issues.
  • Provides consulting support to the Current Product Engineering department regarding applicable standards, requirements, and problem solving.
  • Stays abreast of changes to applicable standards.  Provides, or arranges for training to R&D and Engineering staff as required.
  • The Senior Compliance Engineer may support the Regulatory Representative, but is not responsible for regulatory compliance (FDA, CE technical file) other than compliance with standards that may be required as part of regulatory compliance

Required Experience

  • Bachelors degree in an engineering discipline is required
  • 6+ years engineering experience in medical device or another regulated industry. Minimum of 2 years of compliance engineering experience within a regulated industry. 
  • 3+ years experience in an R&D or Product Development environment
  • Detailed, working knowledge of IEC 60601 (preferred) and/or IEC 61010 regulatory standards.  
  • Familiarity with IEC 60601 Particular Standards 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 leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers 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.

Req ID:  30898
Job Category:  Engineering

Cleveland, OH, US, 44124


Nearest Major Market: Cleveland

Job Segment: Medical Device Engineer, R&D Engineer, Medical Device, Surgery, Product Development, Engineering, Healthcare, Research