Senior Quality Engineer

Medtronic•Tempe, AZ

18h•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at Medtronic’s Tempe Campus. 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. Ensures internal quality processes, procedures and systems are compliant to all governing standards. Collaborates with engineering and manufacturing functions to ensure quality standards are met. 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. Works with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations. Supports manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Development (characterization), OQPQ and Test Method Development and Validation. Uses knowledge of statistics on acceptance criteria, DOE, and comparison testing to support manufacturing engineers in the development of compliant test plans and reports. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Supports risk assessment processes for manufacturing and development including process FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Develops and supports solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures. Supports CAPA investigations, improvements and effectiveness verification testing. Lead and/or support investigations of non-conforming product, materials or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. Responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties. Supports and drives proper change control procedures and collaborates with change owners on their implementation strategies and change documentation. Facilitates group meetings and project leadership that drives comprehensive technical solutions in your quality domain. Communicates clearly regarding technical issues and solutions 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.

Requirements

Requires a Baccalaureate degree in Engineering, Science or technical field and minimum of 4 years of relevant experience in Engineering and/or Quality OR Master's degree in Engineering, Science or technical field with a minimum of 2 years relevant experience OR PhD in Engineering, Science or technical field with 0 years relevant experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
Six Sigma or Lean Sigma belt certification
DRM or DFSS certification
Experience with internal and external audits including FDA, MDSAP and/or TUV.
4+ years of engineering experience in a medical device manufacturing environment
4+ years of Process Quality or Process Engineering experience.
Strong understanding of medical device manufacturing processes and products
Experience with general quality principles, procedures and methodologies
Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
Strong statistical analysis techniques & DOE design and execution
Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications

Responsibilities

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Ensures internal quality processes, procedures and systems are compliant to all governing standards.
Collaborates with engineering and manufacturing functions to ensure quality standards are met.
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.
Works with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations.
Supports manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Development (characterization), OQPQ and Test Method Development and Validation.
Uses knowledge of statistics on acceptance criteria, DOE, and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Supports risk assessment processes for manufacturing and development including process FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
Develops and supports solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.
Supports CAPA investigations, improvements and effectiveness verification testing.
Lead and/or support investigations of non-conforming product, materials or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer.
Responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.
Supports and drives proper change control procedures and collaborates with change owners on their implementation strategies and change documentation.
Facilitates group meetings and project leadership that drives comprehensive technical solutions in your quality domain.
Communicates clearly regarding technical issues and solutions
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.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)