Validation Engineer – MedTech Products

Job Title:

Validation Engineer – Med Tech Products

Location:

Fully Onsite – Minneapolis, Minnesota, USA

Duration:
Long Term

Experience

· 5–7 years minimum in Med Tech or regulated manufacturing environments

Key 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.

Required Qualifications

· 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 Med Tech, 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 Skills

· 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 Med Tech product launches.

• Certification in Six Sigma Green Belt/Black Belt or ASQ CQE (Certified Quality Engineer) is a plus.