Product Safety (ELS) Medical Engineer

Job title: Product Safety (ELS) Medical Engineer

Company: TÜV SÜD

Job description: This role is considered a mid to senior level Engineer. ELS Medical Engineer (Product Safety) position, reporting to the local Team Leader. The Engineer will conduct specified testing and report findings with a high degree of accuracy. This position will maintain confidentiality of customers, products tested and internal proprietary information. Communication with internal and external customers is prompt, courteous and effective, Inspect, test, and photograph products for conformity assessment with international and national regulations with the end result being a Certificate, Test Report, and/or Technical Report for the client in the medical field specifically using active medical device safety standards including IEC 60601-1 and particulars as needed (IEC 60601-2-x.)

Essential Functions:

– Evaluate the electrical medical devices according to the safety standards, create test plans, conduct specified tests and generate test reports.

– Review of risk assessments.

– Timely and efficient communication with client about the project status.

– Adhere to project timelines, efficiently and accurately completing work.

– Participate in internal and external lab accreditation audits.

– Collaborate with other departments if needed.

– Communicate in a courteous and effective manner with internal and external customers in all circumstances including providing quotes, answering questions, relaying messages and providing information with regard to standards, test procedures, to bring product into compliance with requirements. Maintain confidentiality of customers, products tested and appropriate internal information.

– Keep abreast of present and future Product Safety requirements, test procedures, instrumentation, technology and TÜV America Engineering service capabilities by internal training sessions, external seminars and reading of technical articles.

Job Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills and Abilities:

– Demonstrated experience evaluating products (Testing, reporting and certification) following safety standards including but not limited to IEC 60601-1 and particular standards IEC 60601-2x

– Understanding of ISO 14971.

– Knowledge of software life cycle process (IEC 62304) and functional safety is preferred.

– Proficient in operating laboratory test equipment

– Demonstrated ability to work independently and in a team environment.

– Self-starter with a positive outlook and motivated attitude.

– Detail orientated, strategic and self-motivated individual possessing high level of customer service skills.

– Accurate, clear, and timely communicate of information, upward and lateral, including verbal, written and listening skills.

– Comfortable dealing with customers at all levels.

– Ability to plan and organize giving attention to detail and follow-through. Being able to multi-task.

– Reliable judgment that is consistent, adaptable to unusual situations, realistic, common-sense approach to job and problems.

– Willingness to consider other’s ideas and to work with others.


– BS in Electrical Engineering or equivalent is a must.


– Minimum 2 years of TIC industry as in the medical field.

Additional information

Equal Opportunity Employer – Disability and Veteran

TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.

For more information on applicable equal employment regulations, please refer to the following:

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Expected salary:

Location: San Diego, CA

Job date: Sat, 13 Jan 2024 23:14:02 GMT

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