Design Quality Engineer II

Position:
Quality Engineer II at Agiliti – Kansas (Home Office). Remote work possible; travel required to Milwaukee, WI, Kansas, and California.

The Design Quality Engineer II will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers to meet and exceed internal, customer, and regulatory requirements.

• Acts as a team member in supporting quality decisions and practices.
• Applies systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Applies statistical methodologies for assessment and to resolve potential product and quality system issues.
• Develops and maintains or supports the development of testing plans, models and methods for raw materials, materials in process, and finished goods.
• Collaborates with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers.
• Coordinates planning and execution of first article inspections and approvals.
• Coordinates planning, execution, and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams.
• Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans.
• Plans, develops, and oversees execution of Design verification and validation protocols.
• Leads advanced product quality planning activities and assists in preparing new product designs for certification testing.
• Participates in projects and cross‑functional teams; may lead mid‑scale projects.

• Bachelor’s Degree in Engineering, Science, or related technical field.
• 3–7 years of relevant experience, preferably in Design and Development in an ISO
  13485, FDA 21
  
  CFR
  820, and MDSAP regulated environment, mainly for the Design Controls process and requirements.
• ISO
  13485 and FDA 21
  
  CFR
  820 certifications highly desired.
• Working knowledge and experience with metrology labs and GD&T.
• Experience with medical device ISO
  14971 Risk Management.
• Previous working experience in a Design Quality Assurance role for medical device equipment.
• Working knowledge of IEC 60601‑1 Safety standards preferred, but not required.
• Use of statistical analysis software for SPC and Cpk analysis.
• Tooling and fixturing development and qualification (FAI and Gage R&R).
• Minimum 3 years of experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.

• Proficient computer skills in MS Office Suite, including MS Project and Visio.
• Working knowledge of CAD software preferred (Solid Works, Autodesk, etc.).
• Strong analytical skills and attention to detail.
• Strong technical writing skills and effective communication skills.
• Strong presentation, facilitation, and project management skills.
• High level knowledge of DFSS concepts and tools preferred, but not required.

It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. Agiliti will provide reasonable accommodations for qualified individuals with disabilities.