Development Quality Engineer II

Intellectt Inc; Plymouth (MN); On-site; USD 60,000 - 120,000; Full time

Job summary

A leading medical device company is seeking a Development Quality Engineer II in Plymouth, MN to support the development of innovative medical devices. This position focuses on risk management documentation, ensuring compliance with relevant quality assurance standards, and collaborating with various teams to maintain product quality throughout its lifecycle. Candidates should hold a Bachelor's degree in Engineering or a related field and have several years' experience in medical device engineering.

Qualifications

• 3–5+ years of medical device engineering experience.
• Working knowledge of FDA, ISO standards, and GMP.
• Experience with risk management documentation and software analysis.

Responsibilities

• Lead risk management documentation updates (hazard analysis, dFMEA, pFMEA).
• Ensure compliance with FDA regulations and quality standards.
• Collaborate on new product development with cross-functional teams.

Skills

Attention to detail

Organizational skills

Verbal communication

Written communication

Education

Bachelor’s degree in Engineering

Master’s degree in Biomedical Engineering

Master’s degree in Electrical Engineering

Master’s degree in Computer Science

Tools

FDA regulations

ISO 13485

ISO 14971

GMP

IEC 60601

Job description

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Direct message the job poster from Intellectt Inc

Job Title: Development Quality Engineer II

Location: Plymouth, MN (100% Onsite)

Shift: 8:00 AM – 4:00 PM CST

Position Summary:

The Development Quality Engineer II will support the development of medical devices that incorporate electronics and software (capital equipment). This individual will lead and support risk management file updates (including hazard analysis, dFMEA, pFMEA), and ensure design outputs are accurately traced to supplier process controls. Experience in software analysis and supplier quality processes is essential.

Key Responsibilities:

• Develop and maintain risk management documentation (hazard analysis, dFMEA, pFMEA).
• Perform design output tracing to supplier process controls.
• Conduct software analysis related to product development.
• Ensure compliance with FDA regulations, GMP, ISO 13485, ISO 14971, and IEC 60601.
• Collaborate with cross-functional teams including R&D, Quality, and Suppliers to support new product development and ensure robust quality deliverables.
• Monitor and maintain critical quality attributes throughout the product lifecycle.
• Support validation activities and ensure adherence to the quality management system (QMS).

Required Qualifications:

• 3–5+ years of medical device engineering experience in:
• New Product Development (NPD)
• Critical Quality Attributes
• Working knowledge of:
• FDA, ISO 13485, ISO 14971, GMP, IEC 60601
• Strong attention to detail with organizational and follow-up skills.
• Excellent verbal and written communication skills, especially in cross-functional settings.
• Understanding of electronic/software-based systems is a plus.

Education:

• Bachelor’s degree in Engineering or a Technical Field is required.
• Preferred: Advanced degree (Master’s), especially in Biomedical Engineering, Electrical Engineering, or Computer Science.
• Candidates with an Associate’s degree and relevant experience will be considered.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Medical Equipment Manufacturing, Manufacturing, and Biotechnology Research

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