Biomedical Engineering, Calibration, Communication Skills, Continuous Improvement, Cost Effectiveness Analysis, Cross-Functional, Data Analysis, Detail Oriented, Documentation, Implants, Manufacturing, Manufacturing Operations, Manufacturing Process Engineering, Manufacturing/Industrial Processes, Medical Equipment, Network Routers, Operational Support, Orthopedics, Problem Solving Skills, Process Development, Process Flow, Process Validation, Product Support, Project Engineering, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Risk Management, Systems Maintenance, Team Player, Technical Support
Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Manufacturing Transfer Project Engineer for a 12-month+ contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.
This position supports the Operations Engineering Instrument Services Department (ISC) in executing a product transfer project. The role is responsible for supporting site readiness activities, maintaining and updating engineering documentation (e.g., process flows, risk assessments, and work instructions), and enabling inspection readiness through measurement system development, data analysis, and training. Additional responsibilities include coordinating gage and fixture management (including enrollment and calibration), supporting system and router updates, and assisting with process and labeling changes. The position requires strong cross-functional collaboration to ensure alignment with project timelines and deliverables. This role works in partnership with technical subject matter experts, supporting execution, driving task completion, and ensuring consistency and accuracy across all engineering activities.
Responsibilities:
- Supporting Operations Engineering through coordinating and executing product transfer and process implementation activities within manufacturing and service operations.
- Assisting in the planning, developing, and executing of engineering deliverables associated with product transfers, including process validation, inspection readiness, and documentation updates.
- Ensuring that quality standards, regulatory requirements, and internal procedures are met or improved throughout the transfer and implementation process.
- Participating in evaluating manufacturing and inspection processes to ensure efficiency, cost-effectiveness, and compliance with established standards.
- Collaborating cross-functionally with Engineering, Quality, Operations, and external suppliers to support successful execution of project timelines and deliverables.
- Providing technical support for process development, equipment readiness, and inspection methods while identifying opportunities for improvement and risk mitigation.
- Supporting the Operations Engineering Instrument Services Department (ISC) in executing a product transfer project.
- Supporting site readiness activities, including maintaining and updating engineering documentation such as process flows, risk assessments, and work instructions.
- Enabling inspection readiness through measurement system development, data analysis, and training.
- Coordinating gage and fixture management, including enrollment and calibration.
- Supporting system and router updates, as well as assisting with process and labeling changes.
- Working in partnership with technical subject matter experts to support execution, drive task completion, and ensure consistency and accuracy across all engineering activities.
Preferred Qualifications:
- Bachelor's or higher degree in Mechanical, Industrial, or Biomedical Engineering or related field.
- Prior experience within orthopedics, medical devices, or similar regulated industries.
- Strong understanding of manufacturing processes and engineering principles.
- Experience supporting product transfer and process validation activities.
- Ability to develop and update engineering documentation, including process flows, risk assessments, and work instructions.
- Proficiency in measurement system development, data analysis, and inspection readiness.
- Excellent cross-functional collaboration and communication skills.
- Attention to detail with sound judgment and problem-solving abilities.
- Experience with equipment readiness, gage management, and fixture calibration.
- Knowledge of quality systems, regulatory standards, and continuous improvement methodologies.
- Familiarity with medical device manufacturing or orthopedic implant processes.
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iMPact Business Group, Inc.