Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Ensuring quality and compliance for the development and manufacturing of implantable cardiac and neuromodulation medical devices with an accent on process validation and regulatory standards. Focus on designing inspection mechanisms, performing statistical analysis, and managing CAPA investigations to ensure high product reliability.

Location: Onsite in Tempe, Arizona, United States

Salary: $96,800 - $145,200

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering innovation.

What you will do

• Develop and maintain quality standards and protocols for processing medical device materials.
• Ensure internal quality processes and systems comply with all governing regulatory standards.
• Design and implement inspection and testing mechanisms to evaluate product precision and accuracy.
• Support process development and validation including IQ, OQPQ, and Test Method Validation.
• Manage risk assessment processes including process FMEA and CAPA investigations.
• Lead cross-functional teams to investigate and resolve non-conformances in products and materials.

Requirements

• Baccalaureate degree in Engineering, Science, or a technical field with 4+ years of relevant experience (or Master's with 2+ years / PhD).
• Must possess unrestricted U.S. work authorization at the time of hire (sponsorship is only offered for Principal-level roles).
• Strong understanding of regulatory requirements such as ISO and FDA-GMP.
• Proficiency in statistical analysis techniques and DOE design and execution.
• Strong technical writing and presentation skills.

Nice to have

• Experience with electronics manufacturing, including wafer fabs and microelectronics assembly.
• Six Sigma or Lean Sigma belt certification.
• DRM or DFSS certification.
• Experience with internal and external audits including FDA, MDSAP, and/or TUV.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and matching.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).
• Paid time off, paid holidays, and life insurance.