BN Associates Inc. · 7 hours ago
Validation Engineer – MedTech Products
Minneapolis, MN
Contract
Onsite
Senior Level
5+ years expBN Associates Inc. is a company specializing in MedTech products, and they are seeking a Validation Engineer to lead validation activities for plastic injection molding processes. The role involves ensuring compliance with regulatory standards, developing validation protocols, and collaborating with cross-functional teams.
Information Technology & Services
Responsibilities
Lead validation activities for plastic injection molding processes and equipment, ensuring compliance with FDA Quality System Regulations (QSR), ISO 13485, and EU MDR requirements
Develop and execute validation protocols including SAT (Site Acceptance Test), FAT (Factory Acceptance Test), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
Apply deep knowledge of plastic materials, molding technologies, and tooling design to optimize process validation and product performance
Perform statistical analysis using Minitab to support process capability studies, DOE (Design of Experiments), SPC, and root cause investigations
Drive CAPA (Corrective and Preventive Action) processes to ensure timely resolution of quality issues and continuous improvement
Collaborate with cross-functional teams (Quality, Manufacturing, R&D, Regulatory) to ensure validation deliverables align with project timelines and compliance requirements
Prepare and maintain technical documentation including validation plans, reports, risk assessments, and change control records
Support audits and inspections by regulatory authorities and clients, providing validation evidence and compliance assurance
Mentor junior engineers and provide technical guidance on molding validation best practices
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Biomedical, Polymer/Plastics, Industrial, or related field)
5–7 years of hands-on experience in plastic molding validation within MedTech, Pharma, or regulated manufacturing industries
Strong knowledge of IQ/OQ/PQ protocols, SAT/FAT execution, and equipment qualification
Proficiency in Minitab and statistical tools for process validation and capability analysis
Demonstrated experience in CAPA management and root cause analysis methodologies
Familiarity with FDA QSR, ISO 13485, EU MDR, and GMP requirements
Excellent technical writing and documentation skills
Strong communication and stakeholder management abilities
Preferred
Expertise in plastic materials science, mold design, and injection molding optimization
Experience with DOE, SPC, and Six Sigma methodologies
Exposure to automation, robotics, or advanced molding technologies
Prior involvement in global MedTech product launches
Certification in Six Sigma Green Belt/Black Belt or ASQ CQE (Certified Quality Engineer) is a plus
Company
BN Associates Inc.
BN Associates is a business solutions provider, established in 2012 by a passionate women with a vision.
11-50 employees
H1B Sponsorship
BN Associates Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
Funding
Current Stage
Early StageCompany data provided by crunchbase