Sr Quality Engineer

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 the company's Tempe Campus.

1. What is the business title? Sr. Quality Engineer
2. Where is the work to be performed? (Please list preferred UHG facility, if other please specify i.e. remote work, rural, etc.) If hybrid, what is the onsite structure? On-site in Tempe, Arizona at the Tempe Campus (MTC)
3. Can you please provide a summary of the project/initiative which describes what’s being done? 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 the company's Tempe Campus. Initial scope of work may be focused on Inspection Optimization projects in addition to other duties supporting Quality in manufacturing operations of microelectronics assembly and IC and Wafer assembly.
4. What does the team make-up look like – how many members and what is the break-down of the team’s skill sets (ex: 1 PM, 4 Developers, etc.)? Current team includes 5 Operations Quality Engineers and 2 Quality Technicians with varying levels of experience and skillset in the medical device field.
5. What are the top 5 responsibilities for this position? (Please be detailed as to what the candidate is expected to do or complete on a daily basis)

• Leading and managing Inspection Optimization projects that span different processes in our microelectronics assembly line. Including both manual visual inspection and automated/semi-automated inspection methods.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, & OQPQ ensuring compliance and rigor.
• Partnering with process engineers on development of Test Methods and Test Method Validation plans and execution. Spans both attribute and variables TMVs (Gage R&Rs/MSAs).
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Develop and support 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.

What skills/attributes are a must have (Please be detailed as to number of years of experience)?

• Requires a Baccalaureate Engineering degree and minimum of 4 years of relevant experience OR Master's Engineering degree with a minimum of 2 years relevant experience
• Experience with general quality principles, procedures and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation.
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)

What skills/attributes are nice to have?

• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• Six Sigma or Lean Sigma belt certification
• Strong statistical analysis techniques & DOE design and execution
• Strong understanding of medical device manufacturing processes and products

A Day in the Life
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.
• Ensure internal quality processes, procedures and systems are compliant to all governing standards.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Work 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.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation.
• 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.
• Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans andreports.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
• Develop and support 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.
• Support 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. The Sr Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.
• Support and drive proper change control procedures and collaborate with change owners on their implementation
strategies and change documentation.
• Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and
projects simultaneously
• Communicate 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.
TECHNICAL SKILLS
Must Have

• Experience with general quality principles, procedures and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation.
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)

Nice To Have

• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• Six Sigma or Lean Sigma belt certification
• Strong statistical analysis techniques & DOE design and execution
• Strong understanding of medical device manufacturing processes and products