Design Quality Engineer II

🔥 6 minutes ago

🌪️ Kansas – Remote

🌪️ Kansas – Remote

💵 $65.3k - $169.7k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Agiliti

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1939

🏥 Healthcare

📦 Logistics

🤝 B2B

Healthcare • Logistics • B2B

Agiliti is a healthcare services company that manages, maintains and supports medical equipment and clinical technology for healthcare providers. The company offers field operations and customer service, clinical engineering, manufacturing and engineering, technology and information systems, and supply chain/logistics services designed to ensure critical equipment is available and patient-ready. Agiliti positions itself as a B2B partner to hospitals and healthcare organizations, emphasizing mission-driven culture, community service, and diversity and inclusion.

📋 Description

• Utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers. • Act as a team member in supporting quality decisions and practices. • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. • Apply statistical methodologies for assessment and to resolve potential product and quality system issues. • Develop and maintain or support the development of testing plans, models and methods for raw materials, materials in process, and finished goods. • Collaborate with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers. • Coordinate planning and execution of first article inspections and approvals. • Coordinate planning, execution, and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams. • Lead activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans. • Plan, develop, and oversee execution of Design verification and validation protocols. • Lead advanced product quality planning activities and assist in preparing new product designs for certification testing. • Participate in projects and cross-functional teams. May lead mid-scale projects.

🎯 Requirements

• Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required. • 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements. • ISO13485 and FDA 21CFR820 highly desired. • Working knowledge and experience with metrology labs preferred and GD&T. • Experience with medical device ISO14971 Risk Management. • Previous working experience in a Design Quality Assurance role for medical device equipment is required. • Working knowledge of IEC 60601-1 Safety standards preferred, but not required. • Use of statistical analysis software for SPC & CPk Analysis • Tooling and fixturing development and qualification (FAI and Gage R&R) • Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.

🏖️ Benefits

• health insurance options for Medical, Dental & Vision plans • Short- and Long-Term Disability plans • Flexible Spending Accounts • Health Savings Accounts • Life Insurance Options • Paid Time Off • 401K Saving Plan with employer match • Employee Discounts • Tuition Reimbursement • Daily Pay program • Employee Assistance Program • wellness programs