Overview
On Site
Full Time
Skills
Manufacturing Operations
IQ
OQ
PQ
Test Methods
Regulatory Compliance
System Requirements
Auditing
Continuous Improvement
Root Cause Analysis
Problem Solving
Conflict Resolution
Change Management
Corrective And Preventive Action
Technical Writing
Billing
Bill Of Materials
Routers
Feasibility Study
Product Costing
Machining
Collaboration
Quality Assurance
Technical Support
Technical Direction
Medical Devices
Manufacturing
Design Controls
ISO 13485
Good Manufacturing Practice
Statistical Process Control
FMEA
Statistics
Microsoft Office
Microsoft Project
Communication
Job Details
Job Summary:
Roles & Responsibilities:
Education & Experience:
- The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes.
- The role ensures compliance with FDA QSR (21 CFR 820), ISO 13485, and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency across a variety of manufacturing operations.
Roles & Responsibilities:
- Develop and execute process validation strategies, including process characterization and creation of IQ, OQ, and PQ protocols and reports.
- Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies.
- Ensure regulatory compliance with FDA QSR, ISO 13485, and internal quality system requirements; participate in audits as needed.
- Compile, analyze, and interpret validation and SPC data; identify trends and opportunities for continuous improvement.
- Lead root cause analysis and problem-solving activities for technical and process-related issues using quality and statistical tools.
- Support and lead change management activities including Change Management System, Nonconformance Reports, CAPA, Engineering Specifications, and Work Instructions.
- Create, maintain, and improve controlled technical documentation such as prints, procedures, bills of materials (BOM), and routers.
- Establish, evaluate, and improve manufacturing process methods that meet performance, quality, and CTQ requirements.
- Conduct feasibility studies to estimate product cost and analyze capital equipment, capacity, and capability requirements.
- Support a wide variety of manufacturing processes including machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding.
- Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to resolve issues, implement strategies, and provide technical support.
- Develop and execute project plans and schedules; prioritize multiple medium-complexity projects and communicate progress effectively.
- Communicate project plans and technical direction clearly through written and verbal communication with cross-functional teams.
- Read and interpret engineering drawings and specifications to support manufacturing and validation activities.
Education & Experience:
- 4-6 years of experience supporting medical device manufacturing process validations.
- Working knowledge of design control, FDA QSR (21 CFR 820), ISO 13485:2003, and cGMP requirements.
- Proficiency in statistical tools including SPC, PFMEA, CTQ analysis, and general statistics.
- Experience with Microsoft Office Suite and Microsoft Project.
- Strong written and verbal communication skills with the ability to work effectively in cross-functional teams.
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