Medical Device Quality Engineer Job at Stark Pharma Solutions Inc, Minnesota

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  • Stark Pharma Solutions Inc
  • Minnesota

Job Description

Job Title: Medical Device Quality Engineer
Location: Maple Grove, MN (Hybrid)

Experience: 3 5 years

About the Role

We're looking for a Medical Device Quality Engineer to play a key role in ensuring design control, compliance, and product safety for medical electrical equipment and systems. This position requires a balance of technical expertise and quality focus to support product development and lifecycle management.

Responsibilities
  • Lead and support design change projects, including scope definition, risk assessment, and implementation.

  • Develop, maintain, and review documentation such as Design History Files, risk management files, and design input/output records.

  • Plan, create, and execute verification, validation, and usability protocols in compliance with regulatory standards.

  • Support investigations and drive resolutions for quality-related issues, including CAPAs, PIRs, and NCEPs.

Qualifications
  • Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering (preferred).

  • 3 5 years of experience in design quality or engineering roles within the medical device industry.

  • Strong knowledge of design controls, risk management processes, and relevant medical device standards.

Required Skills
  • Excellent problem-solving skills with a methodical and analytical mindset.

  • Strong technical writing and documentation abilities.

  • Effective communication and collaboration skills across cross-functional teams.

Preferred Skills
  • Experience in the cardiovascular field.

  • Familiarity with FDA, ISO 13485, IEC 60601, and related regulatory standards.

Job Tags

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