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Medical Device Testing Engineer at TUV SUD America

Posted in Other 30+ days ago.

Type: Full Time
Location: Rancho Bernardo, California





Job Description:

Medical Device Testing Engineer 128711 Professionals 3 - 5 years of experience Medical Devices & Healthcare
- Perform Safety testing per requirements detailed in international Safety standards and test procedures in a laboratory environment when needed. Review test plans and specifications prior to test.
- Prepare technical reports and other documentation for customer products to the appropriate standards.
- Generate revenue by billing engineering time to T V S D America customers, usually on a project basis (Constructional Review, Testing, Preliminary Evaluations and Certification activities).
- Ensure that all test documentation is completed in an accurate and timely manner and is ready to be incorporated into a test report.
- Maintain knowledge of proper operational procedures of all test equipment and assure proper calibration and functioning of all test equipment.
- Make certain that standard lab operating procedures are followed including, but not limited to, test documentation, equipment storage, test area clean-up and test area sign out.
- Participate in customer kick-off meetings to ensure the customer and lab are fully aware of the test plan and samples are properly configured for the testing in question
- Prepare and review test reports and provide constructive feedback to other personnel to increase the overall quality of the final product
- Document the training needs for new equipment, standards, and procedures, develop a plan for training, and coordinate training sessions with the Technical Lead.
- Keep abreast of the latest design theory, including detailed theoretical knowledge in relevant technical areas, stay up to date with current product standards, test procedures, instrumentation, and technology by participating in internal training sessions, attending external seminars, and reading technical articles
- Ensure that the test areas and equipment are in good condition and ready to perform the tests required by the customer. Examine the requirements of each test scheduled, to avoid conflicts or shortcomings regarding equipment, test areas and personnel qualifications.
- Under general direction of the Service Line Manager and Technical Lead, provide support for daily operations and engineering support for Product Safety Testing according international testing standards and related, and certification of clients products in respective area of expertise.
- Actively work as part of the regional product safety team in preparation and hosting audits (internal/external).
- Promote a positive work environment, through improved communication, improved lab organization, and positive reinforcement for a job well done. To reach a level whereby the positive attitudes of our employees will feed on one another, improving customer satisfaction for both our internal and external customers.
- Provide engineering expertise to T V S D America clients during mitigation to ensure product compliance with international Safety requirements.
- Collaborate with the Technical Support team in association with the Account Executives providing time estimates for testing and other technical support for Safety projects, including the support to customers regarding the application of standards, test procedures, and certification requirements.
- Communicate in a courteous and effective manner with internal and external customers in all circumstances including providing technical feedback for quotes, answering questions, relaying messages and providing information regarding standards, test procedures, to bring product into compliance with requirements. Maintain confidentiality of customers, products tested and appropriate internal information

This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform any other related duties as may be required.


MATERIAL AND EQUIPMENT DIRECTLY USED:



- General office equipment; telephone, personal computer, printer, copier, scanner and other communication tools.


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.


Some domestic travel may be required and international may be required with advance notice.


Equal Opportunity Employer Disability and Veteran


T V S D 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:


EEO is the Law Poster: a href="https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf" https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


EEO is the Law Poster Supplement: a href="https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf" https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf


Pay Transparence Policy Statement: a href="https://www.dol.gov/ofccp/PayTransparencyNondiscrimination.html" https://www.dol.gov/ofccp/PayTransparencyNondiscrimination.html








- BS in Electrical Engineering, or equivalent experience
- Minimum three (3) years Product Safety experience
- Previous experience using consumer product safety standards; Medical Standards being a plus.
- Understanding and previous experience with ISO 17025, CRM and SAP platforms is to be preferred.
- Accurate, clear, and timely communicate of information, upward and lateral, including verbal, written and listening skills.
- Demonstrated ability to work independently and in a team environment;
- Demonstrated, excellent oral and written communication skills;
- Self-starter with a positive outlook and motivated attitude;
- Ability to plan and organize giving attention to detail and follow-through.
- Comfortable dealing with customers at all levels
- Has reliable judgment that is consistent, adaptable to unusual situations, and realistic
- Must have a common-sense approach to solving problems.
- Willingness to consider other s ideas and to work with others

AM PS LAB MM5 Rancho Bernardo California United States


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