What are the responsibilities and job description for the Manufacturing Transfer Engineer position at Grove Technical Resources?
Job Title: Manufacturing Transfer Engineer
Location: Salt Lake City, Utah
Duration: 12-Month Contract
Employment Type: W2 Contract
Travel: Occasional travel to Costa Rica (all travel expenses paid)
We are seeking an experienced Manufacturing Transfer Engineer to join a leading Medical Device Manufacturing organization. This role is ideal for professionals with expertise in manufacturing transfers, technology transfer, process validation, and manufacturing line duplication within a regulated medical device environment.
Key Responsibilities
- Lead and execute manufacturing transfer activities between Contract Manufacturing Organizations (CMOs).
- Develop transfer plans, project schedules, risk assessments, and execution timelines.
- Coordinate technology transfer activities, including manufacturing documentation, SOPs, work instructions, and operator training.
- Support manufacturing line duplication and production expansion to strengthen supply chain resilience.
- Collaborate with Manufacturing, Quality, Operations, Supply Chain, R&D, Regulatory Affairs, and external CMOs.
- Support equipment installation, qualification, and process validation (IQ/OQ/PQ).
- Execute Design Transfer activities in compliance with Design Control and Quality System requirements.
- Prepare and support Engineering Change Orders (ECOs), Change Controls, CAPAs, Deviations, and risk management documentation.
- Troubleshoot manufacturing transfer issues, identify risks, and implement mitigation strategies.
- Drive process optimization and continuous improvement initiatives.
- Track project milestones, communicate status updates, and ensure timely execution.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and internal quality standards.
Required Qualifications
- Bachelor's degree in mechanical, Manufacturing, Biomedical, Industrial Engineering, or a related engineering discipline.
- 5 years of experience in Manufacturing Engineering, Process Engineering, Manufacturing Transfer, Technology Transfer, or New Product Introduction (NPI) within the medical device industry.
- Hands-on experience supporting manufacturing transfers between manufacturing sites and/or external CMOs.
- Experience with manufacturing line duplication, production scale-up, or manufacturing expansion projects.
- Strong experience with equipment qualification and process validation (IQ/OQ/PQ).
- Working knowledge of Design Transfer, Design Controls, Engineering Change processes, CAPA, Change Control, Deviations, Risk Assessments, and FMEA.
- Excellent problem-solving, technical documentation, and cross-functional collaboration skills.
Preferred Qualifications
- Experience working with Contract Manufacturing Organizations (CMOs).
- Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and Design Control requirements.
- Experience with Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
- Familiarity with ERP systems such as SAP or Oracle and PLM systems.
- Experience supporting New Product Introduction (NPI) and manufacturing readiness activities.
Key Skills
- Manufacturing Transfer
- Technology Transfer
- Contract Manufacturing (CMO)
- Product Line Duplication
- Process Validation (IQ/OQ/PQ)
- Equipment Qualification
- Design Transfer
- Engineering Change Orders (ECO)
- Change Control
- CAPA
- FMEA & Risk Management
- FDA 21 CFR Part 820
- ISO 13485
- GMP
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- Root Cause Analysis
- Cross-Functional Collaboration