A
Design Quality Engineer II
Accepting applicationsAgiliti · United States
Full-Time Mid_senior
Posted
22h ago
Category
Manufacturing
Experience
Mid_senior
Country
United States
Who We Are
Agiliti is a leading provider of medical equipment management, service, and solutions. We partner with healthcare organizations to help ensure safe, efficient, and cost-effective patient care through innovative technologies and high-quality service. Our teams collaborate across design, manufacturing, and service to deliver reliable medical devices that improve patient outcomes.
What’s in it for You?
Flexible, remote-based role with travel to key design and manufacturing sites
Opportunity to collaborate cross-functionally with design, manufacturing, and supply chain teams
Hands-on involvement in medical device development and quality systems
Career growth within a high-impact, regulated industry environment
Exposure to advanced product quality planning and regulatory standards
What You Will Do in This Role?
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.
Coordinate 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.
What You Will Need for This Role?
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.
Proficient computer skills in MS Office Suite, including MS Project and Visio.
Working knowledge of CAD software preferred (i.e., SolidWorks, 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.
Show more Show less
Agiliti is a leading provider of medical equipment management, service, and solutions. We partner with healthcare organizations to help ensure safe, efficient, and cost-effective patient care through innovative technologies and high-quality service. Our teams collaborate across design, manufacturing, and service to deliver reliable medical devices that improve patient outcomes.
What’s in it for You?
Flexible, remote-based role with travel to key design and manufacturing sites
Opportunity to collaborate cross-functionally with design, manufacturing, and supply chain teams
Hands-on involvement in medical device development and quality systems
Career growth within a high-impact, regulated industry environment
Exposure to advanced product quality planning and regulatory standards
What You Will Do in This Role?
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.
Coordinate 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.
What You Will Need for This Role?
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.
Proficient computer skills in MS Office Suite, including MS Project and Visio.
Working knowledge of CAD software preferred (i.e., SolidWorks, 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.
Show more Show less