OVERALL RESPONSIBILITIES:

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 TUV America Engineering service capabilities by internal training sessions, external seminars and reading of technical articles

ADDITIONAL RESPONSIBILITIES:

Support the TUV SUD America vision and mission statement. Adhere to all TUV SUD America policies and procedures as outlined in the various Corporate Policies and the Employee Handbook. All employees are responsible for general cooperation and support of all TUV locations. All employees are expected to work in a manner that supports a safe and healthy work environment for themselves and others. This includes following established rules, policies and practices of environmental, health and safety in the workplace.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be interpreted as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

TUV SUD America is an equal opportunity employer.

JOB QUALIFICATIONS:

Minimum 2 years of Electrical/Electronic products Testing & Certification experiences in medical field.

Familiar with active medical device safety standard including IEC 60601-1 and particular standards IEC 60601-2-x.

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

Have experience working in test laboratory, basic knowledge of ISO 17025.

Proficient with MS Windows and MS Office (Word, Excel, PowerPoint, etc.)

Good customer communication skill.

Being able to multi-task.

RESPONSIBILITIES:

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

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.

EDUCATION:

BS in electrical/mechanical Engineering or equivalent.

MATERIAL AND EQUIPMENT DIRECTLY USED:

General office equipment.

WORKING ENVIRONMENT/PHYSICAL ACTIVITIES:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally required to, walk, stoop, kneel, crouch, or crawl, reach with hands and arms; always requires employee to sit, talk or hear, and use hands to finger, handle or feel. Position requires close vision.

Ability and willingness to communicate frequently if required by telephone, fax and email and other communication tools to ensure that the organization's business is completed effectively and in a timely manner.

The employee must occasionally lift and/or move up to 25 pounds.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level is moderate.

Domestic, and some international, travel may be required.

Equal Opportunity Employer - Disability and Veteran

TUV SUD 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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