Associate Medical Device Validation Engineer

United Pharma; Danvers (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role collaborates with Quality, Engineering, Manufacturing, and Operations teams to ensure compliant validation deliverables.

The ideal candidate has a strong engineering background (Electrical or Mechanical) and hands-on experience with IQ/OQ/PQ, TMV, and equipment qualification in a regulated medical device setting, plus solid

Qualifications

• Bachelor's degree in Engineering (Electrical or Mechanical preferred).
• 5-8 years of medical device validation experience.
• Hands-on experience with IQ/OQ/PQ and TMV.
• Experience with process validation and equipment qualification.
• Strong technical writing and documentation skills.

Responsibilities

• Execute IQ, OQ, and PQ protocols.
• Support process validation and equipment qualification activities.
• Develop and execute TMV protocol.
• Support inspection method validation activities.
• Assist with validation protocol generation, execution, and reporting.
• Support root cause investigations.
• Review and analyze validation data.
• Collaborate with Quality, Manufacturing, and Engineering teams.
• Support remediation and continuous improvement initiatives.
• Maintain validation documentation per FDA/ISO requirements.

Skills

IQ/OQ/PQ protocols

TMV validation

Root cause analysis

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering (Electrical or Mechanical preferred)

Tools

TMV protocol development

Job description

United Pharma is seeking an Associate Validation Engineer to support medical device validation activities within a manufacturing and remediation environment. This role collaborates with Quality, Engineering, Manufacturing, and Operations teams to ensure compliant validation deliverables.

The ideal candidate has a strong engineering background (Electrical or Mechanical) and hands-on experience with IQ/OQ/PQ, TMV, and equipment qualification in a regulated medical device setting, plus solid