Seeking Talent with a strong background in Design Quality Engineering supporting projects involving Electromechanical, Mechanical, and Materials based Medical Devices.
Your dedication is important to our customers and, most importantly, to their patients.
Medtronic is currently seeking a Principal Quality Engineer
This position has the responsibility and authority to provide Quality Engineering 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. QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams.
Do meaningful work, make a difference, and improve lives — starting with your own.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
A Day in the Life
•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 establishes quality and reliability expectancy targets for 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 action effectiveness and timeliness. Assists audits of finished products, final inspections, returned and serviced products
•Provides statistical analysis and coaching to project teams; EG: Design of Experiments (DOE), Hypothesis testing, gauge R&R, reliability engineering statistics, tolerance intervals, etc.
Functions as Quality Core Team Leader (QCTM): Engages extended quality team functions and represents them on assigned new product development core teams.
Responsibilities may include the following and other duties may be assigned.
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Must Have: Minimum Requirements
•Bachelor’s degree in engineering or sciences.
YEARS OF EXPERIENCE:
•7 + years experience with a Bachelor's degree or 5 + years experience with a Master’s degree.
Nice to Have – (Preferred Qualifications):
•Bachelor’s degree in Electrical, Mechanical, Biomedical, or Biological engineering preferred.
•Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired. If Bachelors or Masters Degree is not in engineering an applicable professional certification is required.
•Experience in medical device or applicable regulated 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.
•Demonstrated ability to lead project teams to successful completion.
•Prior experience in a supervisor/manager capacity preferred.