Be an early applicantLess than 25 applicantsPosted by Agency
Intellectt Inc ยท 2 days ago
Engineer III
United States
Contract
Remote
Mid, Senior Level
5+ years exp
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Responsibilities
Resolve compliance issues by collaborating with various engineering disciplines such as electrical, mechanical, and software.
Define compliance strategies to certify and list products.
Provide technical review of products 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 third-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 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, IEC 60601-11, ISO 10535, and EN 60601-2-52.
Detailed knowledge of 60601-1-2 preferred.
Qualification
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Required
BS Degree in Electrical or Mechanical Engineering or equivalent experience
Minimum of 5 years' experience in the medical device industry
Minimum of 5 years' experience in Compliance Engineering, including working with Notified Bodies and standards
Previous design compliance experience
Excellent written and oral communication skills
Self-motivated with high performance standards
Preferred
Knowledge of IEC-based safety standards preferred: IEC/EN/UL 60601-1, IEC 60601-11, ISO 10535, and EN 60601-2-52
Detailed knowledge of 60601-1-2 preferred
Company
Intellectt Inc
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry.
1,001-5,000 employees
H1B Sponsorship
Intellectt Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (231)
2022 (367)
2021 (259)
2020 (129)
Funding
Current Stage
Late StageCompany data provided by crunchbase
