Sr Quality Engineer

Job Description

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.

• 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, spanning both attribute and variable TMVs (Gage R&Rs/MSAs).
• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished material products.
• Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics, including performance scorecards, issue reporting, and other performance measures.

• Baccalaureate Engineering degree and minimum of 4 years of relevant experience, OR Master’s Engineering degree with minimum of 2 years relevant experience.
• Experience with general quality principles, procedures and methodologies.
• Proficiency in Microsoft Office Applications (Word, Excel, Power point, Teams).
• Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
• Strong overall communication skills, both in technical writing and presentation.
• Strong understanding of regulatory requirements (ISO, FDA‑GMP, etc.).
• Knowledge of technical structured problem‑solving methodologies (DMAIC, Ishikawa, 8D, etc.).

• 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.

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished material products.
• Ensure internal quality processes, procedures and systems are compliant to all governing standards.
• Collaborate 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.
• Support manufacturing development and continuous improvement as a Quality team member for process 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; performs statistical analysis.
• Uses knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers.
• Ensures that corrective measures meet acceptable reliability standards and documentation is compliant.
• Supports risk assessment processes for manufacturing and development.
• Supports CAPA investigations, improvements, and effectiveness verification testing.
• Leads and/or supports investigations of non‑conforming product, materials, or processes, documenting non‑conformances and communicating with applicable parties.
• Supports and drives proper change control procedures and collaborates with change owners on implementation strategies and documentation.
• Facilitates group meetings and project leadership that drives comprehensive technical solutions for…