Design Assurance Engineer

Saluda Medical • Hopkins, MN

1d

About The Position

The Design Assurance Engineer is a quality engineering role supporting new product development, sustaining engineering, and post-market activities. The role provides quality engineering support to cross-functional teams to ensure design controls and subsequent production and process controls are adequate and comply with internal and regulatory requirements. It supports development of product requirements, product verification and validation, risk management, and design change control. The position also mentors cross-functional teams on product development, design control, and risk management deliverables, and represents Quality in supporting quality disciplines, decisions, and practices.

Requirements

• Bachelor’s degree or higher in a technical field, such as Biomedical, Mechanical, or Electrical Engineering, or another technical field.
• Comfortable working independently and as part of a cross-functional team.
• Flexible, positive, and team-oriented attitude.
• Good verbal and written communication skills, including comfort speaking and presenting to others.
• Ability to manage multiple priorities and work with ambiguity.
• Ability to work independently under limited supervision.
• Strong analytical skills.

Nice To Haves

• Training experience in FDA regulations or ISO standards.

Responsibilities

• Work on cross-functional teams to identify and implement effective design controls and support product development from concept through commercialization.
• Support product design and design changes through cross-functional collaboration, ensuring activities comply with internal and regulatory requirements.
• Mentor cross-functional teams through the product development process, particularly on design control and risk management deliverables.
• Complete risk analysis studies of designs and processes using FMEA and other risk management tools.
• Maintain current knowledge of regulatory compliance requirements for product design, development, transfer, and commercialization.
• Represent Quality by supporting quality disciplines, decisions, and practices.
• Liaise with internal and external departments to build collaborative partnerships.
• Support changes to Design History File (DHF) documentation.
• Review and approve design verification test plans, protocols, and reports.
• Develop test method validation requirements.

What This Job Offers

• Job Type: Full-time