Development Quality Engineer

Intellectt Inc; Saint Paul (MN); On-site; USD 75,000 - 110,000; Full time

Job summary

A leading company is seeking a Development Quality Engineer in Saint Paul to support new product development for structural heart products. This role involves ensuring compliance with quality systems while collaborating with cross-functional teams. Applicants should have a Bachelor’s degree in Engineering and experience with quality methodologies.

Qualifications

• 0–5 years engineering experience using quality tools/methods.
• Able to work in a fast-paced, cross-functional environment.

Responsibilities

• Deliver quality-related project tasks on time.
• Define and verify product/customer requirements.
• Lead Risk Management, FMEAs, and analyze field data.

Skills

Communication

Organization

Problem Solving

Education

Bachelor’s in Engineering, Chemistry, Life Science, or related field

Job description

1 week ago Be among the first 25 applicants

Direct message the job poster from Intellectt Inc

Unicorn Recruiter | Tech & Business Talent Specialist | People-First Hiring Partner | Empowering Careers, Enabling Growth @ Intellectt Inc |…

Hello,

One of my clients is currently seeking a Development Quality Engineer. If this role aligns with your experience or interests, I’d love to connect with you. Please share your updated resume with me at [e-mail], or feel free to call me directly at [phone] to discuss further.

Position: Development Quality Engineer

Location: St. Paul, MN 55117

Duration: 12 Months | Shift: 8:00 AM – 5:00 PM CST

Summary:

Seeking a Development Quality Engineer to support new product development and sustaining activities for structural heart products. Ensures compliance with quality systems and regulatory standards, while collaborating with cross-functional teams to maintain product safety and performance.

Key Responsibilities:

• Deliver quality-related project tasks on time.
• Define and verify product/customer requirements.
• Lead Risk Management, FMEAs, and analyze field data.
• Develop/validate test and inspection methods.
• Support design verification/validation and root-cause analysis.
• Assist in manufacturing process and process validation.
• Review/approve document changes and CAPAs.
• Support cleanroom product builds and audits.
• Author/revise procedures per FDA, ISO, and internal standards.
• Collaborate with R&D, Program Management, and Process Development.

Required:

• Bachelor’s in Engineering, Chemistry, Life Science, or related field.
• 0–5 years engineering experience using quality tools/methods.
• Strong communication, organization, and problem-solving skills.
• Able to work in a fast-paced, cross-functional, matrixed environment.
• Occasional travel (<5%).

Preferred:

• Biomedical or mechanical engineering with medical device internships.
• Experience with heart valves, implantable devices, or delivery systems.
• Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR, MDSAP, GMP/GDP.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering and Quality Assurance

• Industries

  Medical Practices and Medical Equipment Manufacturing

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