The Quality Test Tech II will provide a principal role in product development projects for quality planning, and perform electrical and mechanical testing of new and existing products to assure compliance to UL, IEC, FDA and Nonin standards.
Essential Job Functions:
- Work with Quality Engineers to develop quality plans to support product development projects, product update requests, and failure analysis investigations.
- Work with Quality Engineers to develop quality lab test scheduling and priorities.
- Lead and/or execute internal and external compliance testing activities.
- Develop data acquisition programs and testing apparatus to support testing equipment.
- Write test plans and test reports that include appropriate data analysis and results.
- Analyze test results and suggest modifications to improve product design, testing or manufacturing processes.
- Perform electrical, EMC, ESD and mechanical testing against approved test plans to assure compliance to UL, IEC, FDA and Nonin standards to support verification efforts.
- Participate in risk management process, in accordance with Risk Management procedure.
- Support validation efforts of approved testing to assure compliance.
- Maintain the equipment and cleanliness of the Quality Assurance Lab.
- Supervise a log of testing and other activities consistent with lab SOPs and Good Laboratory Practices.
- Travel as necessary to support external testing activities and training.
Required Education & Experience:
- Associate’s Degree in Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience.
- 4 years of applicable experience
Required Knowledge, Skills & Abilities:
- Microsoft Word and Excel proficient.
- Must be able to function independently without direct supervision, performing both routine and highly complex testing.
- Able to understand schematics, assembly drawings, data sheets, and process sheets.
- Able to interpret applicable standards to assure compliance.
- Works with strong ownership, agility and courage.
- 2 years experience in a Medical Device compliance-testing laboratory.
- Experience with electrical safety testing.
- Experience with EMI and ESD testing and evaluation.
- Ability to sit, stand and/or walk for 8 hrs/day.
- Ability to lift up to 40lbs.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.