Development Quality Engineer (Medical Device)

Intellectt Inc; Minnesota; On-site; USD 85,000 - 95,000; Full time

Job summary

A leading company in the medical device sector is seeking a Development Quality Engineer in St. Paul, MN. This contract position emphasizes quality assurance tasks for NPD projects, risk management activities, and regulatory compliance. Ideal candidates are recent graduates or professionals with up to five years of experience in medical devices, with a strong background in risk management and validation processes.

Qualifications

• 0–5 years of experience in medical devices (internships/co-ops accepted).
• Strong knowledge of cGMP, GDP, ISO 13485, 14971, 21 CFR Part 820.
• Excellent communication skills.

Responsibilities

• Lead quality deliverables for NPD projects.
• Conduct and document risk management activities (FMEA, field data review).
• Participate in process validation and review quality records.

Skills

Risk management

Verification/Validation

Problem-solving

Team collaboration

Education

Bachelor’s in Engineering

Life Sciences or related field

Job description

Development Quality Engineer (Medical Device)

Development Quality Engineer (Medical Device)

1 week ago Be among the first 25 applicants

Direct message the job poster from Intellectt Inc

Talent Acquisition Specialist at Intellectt,As a medical device recruiter, we connect top talent with leading companies. Our focus on industry…

Role: Development Quality Engineer

Location: St. Paul, MN

Duration: 12 Months

Key Responsibilities:

• Lead quality deliverables for NPD projects
• Conduct and document risk management activities (FMEA, field data review)
• Participate in process validation and process control activities
• Review and approve DCOs, CAPAs, and quality records
• Contribute to regulatory audits, document control, and QMS updates
• Build strong cross-functional partnerships with R&D, PM, and Process Development

Must-Have Qualifications:

• Bachelor’s in Engineering, Life Sciences, or related field
• 0–5 years of experience in medical devices (internships/co-ops accepted for recent grads)
• Strong skills in risk management, verification/validation, root cause analysis
• Knowledge of cGMP, GDP, ISO 13485, 14971, 21 CFR Part 820
• Excellent communication, problem-solving, and team collaboration

Preferred Experience:

• Prior experience with:
• Bioprosthetic heart valves or implantable devices
• Design Assurance or Development Quality
• Test method validation, process validation, CAPA
• Familiar with:
• EUMDR, MDSAP
• Cleanroom manufacturing and medical device audits

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing, Production, and Product Management

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing

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