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Remote Quality Engineer Medical Device Jobs in Minnesota

UnitedHealth Group

Senior Quality Engineer

Minnetonka, MN · Remote

$90K - $122K/yr

Quality engineering leadership: Lead the QE strategy and drive end-to-end test automation across web, API, mobile, cloud, and AI-powered applications. * Automation framework development: Design ...

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Remote Quality Engineer Medical Device information

What does a remote quality engineer in the medical device industry do?

A Remote Quality Engineer in the medical device industry is responsible for ensuring that medical products meet regulatory and quality standards while working from a remote location. Their duties often include reviewing and improving quality processes, conducting audits, analyzing data to identify trends or issues, and ensuring compliance with regulations such as FDA or ISO 13485. They collaborate with cross-functional teams to resolve quality issues and may also be involved in risk management and validation activities. Remote Quality Engineers use digital tools to communicate and manage documentation, making it possible to fulfill their role away from a traditional office or manufacturing environment.

What are the key skills and qualifications needed to thrive as a remote quality engineer in medical devices, and why are they important?

To thrive as a Remote Quality Engineer in Medical Devices, you need a solid background in quality assurance, regulatory compliance (such as FDA and ISO 13485), and engineering principles, typically supported by a relevant engineering degree. Proficiency with quality management systems (QMS), document control software, and risk assessment tools is common, and certifications like ASQ CQE are highly valued. Strong attention to detail, effective problem-solving, and clear remote communication skills help ensure compliance and collaboration across distributed teams. These abilities are crucial for maintaining product safety, meeting regulatory standards, and driving continuous improvement in a regulated industry.

How does a remote quality engineer in the medical device industry effectively collaborate with cross-functional teams despite working off-site?

Remote Quality Engineers in the medical device sector regularly use digital collaboration tools such as video conferencing, shared documentation platforms, and cloud-based quality management systems to stay connected with design, manufacturing, and regulatory teams. While working remotely poses challenges in terms of immediate access to physical devices and face-to-face communication, frequent virtual meetings and clear documentation help ensure alignment on project goals and compliance requirements. Building strong relationships with on-site team members and proactively seeking feedback are key strategies for maintaining effective collaboration and ensuring product quality.
What are the most commonly searched types of Quality Engineer Medical Device jobs in Minnesota? The most popular types of Quality Engineer Medical Device jobs in Minnesota are:
What are popular job titles related to Remote Quality Engineer Medical Device jobs in Minnesota? For Remote Quality Engineer Medical Device jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Remote Quality Engineer Medical Device jobs in Minnesota look for? The top searched job categories for Remote Quality Engineer Medical Device jobs in Minnesota are:
What cities in Minnesota are hiring for Remote Quality Engineer Medical Device jobs? Cities in Minnesota with the most Remote Quality Engineer Medical Device job openings:
Remote Quality Engineer Medical Device jobs near you
Infographic showing various Remote Quality Engineer Medical Device job openings in Minnesota as of August 2026, with employment types broken down into 86% Full Time, 9% Part Time, and 5% Contract. Highlights an 100% Remote job distribution.

Principal Design Assurance Engineer

Tactile Medical

New Brighton, MN • On-site, Remote

Other

Posted 21 days ago

Tactile Medical rating

8.6

Company rating: 8.6 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Principal Design Assurance Engineer serves as the technical leader for Design Assurance across the product lifecycle. This role is responsible for defining and driving quality strategy in new product development, ensuring compliance with global regulatory requirements, and leading best practices in design controls, risk management, and design verification and validation. The Principal Engineer provides technical mentorship, influences organizational quality strategy, and partners with cross-functional leadership to ensure the development of safe, effective, and compliant medical devices.

Accountabilities & Responsibilities

  • Serve as the Design Assurance subject matter expert for New Product Introduction programs
  • Establish Design Assurance strategies, quality plans, and risk-based approaches for product development and lifecycle management
  • Provide technical leadership and influence decisions across Engineering, Program Management, Operations, Marketing, and Regulatory Affairs
  • Own quality system processes for Design Control, Risk Management, and Product Development processes
  • Lead design assurance activities throughout the product lifecycle from concept through commercialization, sustaining engineering, and product retirement.
  • Ensure compliance with FDA, ISO 13485, ISO 14971, IEC 62366, IEC 60601, and other applicable standards
  • Serve as reviewer and approver for critical design control deliverables and major design decisions
  • Provide leadership for product-level risk management activities including FMEA, Fault Tree Analysis, and Hazard Analysis
  • Lead design verification and validation strategies, including usability validation, and statistical justification of testing approaches
  • Provide technical oversight for complex investigations, root cause analyses, and product quality issues
  • Mentor engineers and provide technical coaching across the organization
  • Lead cross-functional quality initiatives with organization-wide impact and contribute to strategic planning and capability development
  • Other duties as assigned

Qualifications

Required:

  • Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, or related technical discipline required
  • 10+ years of experience in quality engineering, design assurance, or product development within the medical device industry
  • Demonstrated success leading quality strategy for complex medical device development programs through commercialization

Preferred:

  • ASQ certification such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Six Sigma Black Belt (CSSBB), or equivalent quality certification
  • Experience serving as a design assurance or quality lead for electromechanical, software-enabled, or connected medical device products
  • Prior experience mentoring engineers, leading quality capability-building initiatives, or influencing quality strategy across a matrixed organization

Knowledge & Skills

  • Expert knowledge of Design Controls, Risk Management, and Product Realization for medical devices
  • Expert understanding of FDA Quality System Regulation, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
  • Advanced knowledge of statistical methods, reliability engineering, validation methodologies, and data analytics
  • Demonstrated ability to lead through influence without direct authority.
  • Strong business acumen with the ability to balance risk, compliance, and business objectives
  • Exceptional communication, facilitation, and executive presentation skills.
  • Demonstrated ability to lead multiple highly complex technical initiatives simultaneously.
  • Proven mentoring and leadership capabilities.
  • Ability to translate regulatory and quality requirements into scalable business processes.

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