Design Compliance Engineer

Stefanini Group is hiring!

Stefanini is looking for Engineer in Skaneateles, NY

For quick Apply, please reach out to Nitin Kumar Chandila - call: 248-263-3906/ email: NitinKumar.Chandila@stefanini.com

Work Hours: M-F (40 hours)

Work Location: Skaneateles, NY

Shift: 1st Shift

Work with NPD and Sustaining teams to realize compliant products based on national and international codes. Determine applicable standards and interpret them for new and current products.

·       Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.

·       Define compliance strategies to certify and list products.

·       Provide technical review of product to ensure alignment with national and international codes.

·       Help maintain and sustain the product technical files for the production life of the products.

·       Assist product development teams in applying and understanding design standards and codes.

·       Submit required compliance reports to safety agencies and review 3rd party technical files and

·       documentation.

·       Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.

·       Experience working in a regulated industry.

·       Experience working in the codes and standards capacity at a Medical Device manufacturer, or hospital electrical and medical gas supplier.

·       Demonstrated ability to assess the application of Codes & Standards to new product designs in order to obtain & maintain the agency certifications specified by the design requirements (e.g. UL, IEC, VDE, CSA).

·       Knowledge of IEC based safety standards, preferred: IEC/EN/UL 60601-1, lEC 60601-11, ISO10535 and EN 60601-2-52.

·       Detailed knowledge of 60601-1-2 preferred.

·       BS Degree in Electrical or Mechanical Engineering or equivalent experience.

·       Previous Design Compliance Experience.

·       Minimum of 5 years' experience in the medical device industry.

·       Minimum of 5 years' experience in Compliance Engineering equivalent in working with Notified Bodies and standards preferred.

·       Excellent written and oral communication skills.

·       Self-motivated with high performance standards. 

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.