Senior Quality Engineer needed with an Electrical Engineering background- Medtronic Surgical Technologies –
Medical Device Industry/Regulated Industry Experience Required
STRONG Failure Analysis experience needed.
The Senior QA Engineer represents the organization in providing solutions to difficult technical issues associated with specific programs or projects, representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations.
- Participates in Business Team operations to approve testing of all new product designs, design test parameters for R&D, Operations and QA, conduct reliability assessments, evaluates and approves ECN changes for existing products, monitor design developments for maintaining quality compliance and assists in software engineering, testing, and validation.
- Partners with Mfg. Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives.
- Participates in new product development, and establish quality and reliability expectancy of the finished product.
- Identifies, applies, and updates engineering and technical standards requirements for devices, including standards compliance in product design, manufacture, and labeling.
- Investigates and reports on corrective actions effectiveness and timeliness.
- Assists audits of finished products, final inspections, returned and serviced products.
- Complies with the Medtronic Xomed Quality System.
BASIC QUALIFICATIONS
- Minimum of 5-8 years experience with a Bachelors degree in Electrical Engineering or 3-6 years with a Masters degree in Electrical engineering.
- 3-5 Quality Engineering experience with an emphasis on Failure analysis of electronic components.
- Experience in medical device design and application of test standards.
- Minimum of 5 years industry experience, preferably in the medical device manufacturing industry.
- Working knowledge of IEC606-1, UL2601-1, EMC Directive, and other appropriate industry standards.
- Experience in application of statistical methods to design reliability and process capability.
- Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
- Complete understanding and wide application of technical principles, theories, and concepts in the field.
- Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
- Excellent presentation skills.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- Working knowledge of appropriate industry standards.
- Experience in application statistical methods to design reliability and process capability.