Validation Engineer (Medical Device Systems & Software Validation)
Job Description
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:
- Bachelor’s 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
#ZRCompany DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.
Company Description
As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.