Validation Engineer (Medical Device Systems & Software Validation)
Validation Engineer (Medical Device Systems & Software Validation)
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Job Description
Title: Validation Engineer (Medical Device Systems & Software Validation)
Client: Medical device Manufacturing Company
Location: Maple Grove MN 55311
Duration: 12 months contract
Focus Area: FDA-regulated Medical Device Software/Systems Validation
Job Description:
Ensure the quality of software applications and equipment by validating and qualifying to defined specifications in alignment with FDA regulations. This role involves creating and executing comprehensive documentation for systems including PLCs SCADA databases Visual Basic applications and platforms with electronic records/signatures.
Key Responsibilities:
- Develop comprehensive hardware/software specifications for complex systems
- Submit documentation (specs protocols reports) via Change Request for approvals
- Create and execute validation/qualification protocols and accurately record results
- Perform gap analysis issue tracking and follow-ups on validation findings
- Utilize Product Data Management (PDM) systems for document control
- Provide guidance on FDA/QSR regulations and internal validation policies
- Lead or contribute to vendor evaluations and project activities
- Mentor and peer-review work of junior engineers (Engineer I & II)
- Define and promote best practices and standardization across projects
- Deliver all project milestones in accordance with schedule and scope
- Actively participate in cross-functional engineering initiatives
Minimum Qualifications:
- Bachelors degree in Engineering discipline
- 5 9 years of hands-on validation/qualification experience
- Medical device manufacturing and compliance documentation experience
- Strong knowledge of Microsoft Office Suite
- Proficient in SDLC and working with regulated systems/interfaces
- High attention to detail and multitasking ability
- Excellent verbal and written communication skills
- Collaborative positive attitude with ability to work across departments
Preferred Qualifications:
- Experience working in an FDA-regulated environment
- Participated in regulatory audits
- Hands-on with 21 CFR Part 11 compliance (electronic records/signatures)
- Experience in a Quality/Compliance function
Employment Type
Full-time
