Transfer Engineer -II

Transfer Engineer I-II

The Transfer Engineer I–II plays a key role in supporting and leading the transfer of interventional and transcatheter medical devices from development into production. This position contributes to Aptyx's end-to-end solutions for Class II and III medical devices, including implants, catheters, and other disposable products.

This role spans early-career to mid-level engineering capability, with increasing responsibility for process development, validation, equipment implementation, and customer engagement. The Transfer Engineer will work cross-functionally with Operations, Quality, Supply Chain, and customers to deliver robust, scalable, and cost-effective manufacturing processes.

Quality System & Compliance

• Follow the Aptyx Quality System and all applicable SOPs within the Training Matrix.
• Ensure compliance with medical device regulations and internal validation standards.

Process Development & Manufacturing Transfer

• 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.

Validation & Risk Management

• 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.

Production Support & Continuous Improvement

• 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.

Design for Manufacturability (DFM)

• Participate in (I) and lead (II) DFM discussions with R&D.
• Recommend design improvements to enhance manufacturability, yield, and cost.

Supplier & Material Management

• Coordinate with suppliers on material specifications, validations, and quality issues.
• Support (I) or lead (II) supplier validations and material change processes.

Customer & Cross-Functional Collaboration

• 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.

Documentation & Systems

• Review and update manufacturing documentation (work instructions, BOMs, routings).
• Maintain ERP data and engineering change orders.
• Write and review test methods and validation protocols.

Project Execution

• Support (I) or lead (II) project execution, ensuring alignment to timelines, scope, and budget.
• Demonstrate increasing ownership and decision-making responsibility at Level II.

• Background in disposable medical device design, development, and manufacturing.
• Knowledge of materials, prototyping, and manufacturing processes.
• Project management experience preferred (increasing expectation at Level II).

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field required.

• Level I: 1+ years of relevant engineering experience (medical device preferred)
• Level II: 2–5 years of experience in medical device engineering or manufacturing
• Experience with Solid Works or equivalent CAD software preferred.

• Proficiency in MS Office, CAD (Solid Works), and 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
• Experience with Lean Manufacturing and Six Sigma tools (preferred for Level II)

• Level I: Applies foundational engineering principles; executes tasks with guidance
• Level II: Independently develops processes and solves complex technical problems

• Level I: Supports validation execution and documentation
• Level II: Leads validation strategy and ensures compliance and robustness

• Level I: Contributes to project tasks and meets assigned deadlines
• Level II: Owns project deliverables, timelines, and execution with minimal oversight

• Level I: Identifies inefficiencies and supports improvement initiatives
• Level II: Leads Lean projects and drives measurable operational improvements

• Level I: Communicates effectively within team; escalates issues appropriately
• Level II: Independently interfaces with customers and leads cross-functional…