Transfer Engineer I-II
About The Position
The Transfer Engineer I–II supports and leads the transfer of interventional and transcatheter medical devices from development into production, contributing to Aptyx's end-to-end solutions for Class II and III medical devices, including implants, catheters, and other disposable products. This role covers early-career to mid-level engineering capabilities, with increasing responsibility for process development, validation, equipment implementation, and customer engagement. The Transfer Engineer collaborates cross-functionally with Operations, Quality, Supply Chain, and customers to deliver robust, scalable, and cost-effective manufacturing processes.
Requirements
- Background in disposable medical device design, development, and manufacturing.
- Knowledge of materials, prototyping, and manufacturing processes.
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field.
- Level I: 1+ years of relevant engineering experience (medical device preferred).
- Level II: 2–5 years of experience in medical device engineering or manufacturing.
- Proficiency in MS Office.
- Proficiency in CAD (SolidWorks).
- Proficiency in ERP systems.
- Understanding of medical device regulations and validation methodologies.
- Strong analytical and problem-solving skills.
- Effective communication and collaboration skills.
- Ability to manage multiple priorities in a fast-paced environment.
Nice To Haves
- Project management experience (increasing expectation at Level II).
- Experience with SolidWorks or equivalent CAD software.
- Experience with Lean Manufacturing and Six Sigma tools (preferred for Level II).
Responsibilities
- Follow the Aptyx Quality System and all applicable SOPs within the Training Matrix.
- Ensure compliance with medical device regulations and internal validation standards.
- Support (Level I) and lead (Level II) hands-on process development of catheters, implants, and disposable medical devices.
- Assist (I) or independently develop (II) pilot and manufacturing equipment, processes, and procedures.
- Support (I) and lead (II) equipment acquisition, setup, and installation qualification (IQ).
- Execute design changes and support product line transfers into production.
- Contribute to (I) and independently plan/execute (II) validation activities including IQ, OQ, PQ, TMV, Gage R&R, and MSA.
- Support (I) and lead (II) development and maintenance of pFMEAs and Master Validation Plans (MVPs).
- Ensure validation documentation is accurate, complete, and audit-ready.
- Support production builds, line setup, troubleshooting, and training activities.
- Lead (II) or contribute (I) to Lean and Six Sigma initiatives to reduce waste and improve efficiency.
- Conduct time studies, capacity analysis, and layout optimization to improve throughput.
- Analyze COGS and identify cost-reduction opportunities.
- Participate in (I) and lead (II) DFM discussions with R&D.
- Recommend design improvements to enhance manufacturability, yield, and cost.
- Coordinate with suppliers on material specifications, validations, and quality issues.
- Support (I) or lead (II) supplier validations and material change processes.
- Communicate project status, risks, and technical updates to customers.
- Escalate issues appropriately (I) or independently manage customer communication (II).
- Collaborate with cross-functional teams including Operations, Quality, and Supply Chain.
- Review and update manufacturing documentation (work instructions, BOMs, routings).
- Maintain ERP data and engineering change orders.
- Write and review test methods and validation protocols.
- Support (I) or lead (II) project execution, ensuring alignment to timelines, scope, and budget.
- Demonstrate increasing ownership and decision-making responsibility at Level II.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
