Principal Design Assurance Engineer

Skills Alliance; Minnesota; On-site; USD 120,000 - 150,000; Full time

Job summary

A leading medical device innovator is seeking a Principal Design Assurance Engineer to support the design assurance of a cutting-edge heart valve. The role involves leading design assurance efforts, enhancing quality processes, and collaborating across teams. Ideal candidates have a strong background in medical device development, particularly in cardiology-focused solutions.

Qualifications

• Minimum 10 years in the medical device industry.
• Expertise in ISO 13485, CE Marking, EN ISO 5840, EU MDR, FDA regulations.

Responsibilities

• Lead design assurance efforts throughout product development.
• Review and enhance Quality Management System processes.
• Collect, analyze, and present data using statistical methods.

Skills

Leadership

Communication

Problem Solving

Data Analysis

Education

BSc in a technical or engineering field

Tools

Microsoft Office Suite

Job description

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Direct message the job poster from Skills Alliance

Job Title: Principal Design Assurance Engineer

Job Type: Full-time, permanent

A privately held medical device innovator that is focused on developing minimally invasive solutions for structural heart conditions are seeking a Principal Design Assurance Engineer. This individual will play a critical role in supporting the design assurance of a cutting-edge heart valve and its transcatheter delivery system. This position is ideal for someone with a strong foundation in cardiology-focused medical device development, particularly implantable heart valves and catheter-based delivery platforms.

Responsibilities:

• Apply rigorous attention to detail, analytical acumen, and strong problem-solving skills.
• Provide clear and effective communication to internal and external stakeholders.
• Lead design assurance efforts throughout product development, including design reviews, verification and validation activities, test method development and validation, requirement management, test case traceability, and risk management.
• Support the transition of new product development into manufacturing.
• Review and enhance Quality Management System (QMS) processes related to design controls and compliance with EN ISO 5840.
• Collect, analyze, and present data using statistical and analytical methods.
• Collaborate across functional teams, contributing actively in meetings and decision-making processes.

Requirements:

• BSc in a technical or engineering field,
• Minimum 10 years in the medical device industry
• Expertise in ISO 13485, CE Marking, EN ISO 5840, EU MDR, FDA medical device regulations (21 CFR 820).
• Solid knowledge of relevant manufacturing processes.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook).
• Strong written and verbal communication skills.
• Ability to multitask and thrive in a dynamic, fast-paced environment.
• Proven leadership and team collaboration capabilities.
• Professional handling of sensitive or confidential information.
• Competence in data analysis, statistical techniques, and technical presentations.
• Independent working style with a proactive approach to seeking guidance when needed.

Please reach out to [e-mail] for further details.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Medical Equipment Manufacturing

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