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.

Duties and Responsibilities

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.

Qualifications

• 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).

Education

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

Experience

• 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 SolidWorks or equivalent CAD software preferred.

Skills, Knowledge, and Abilities

• Proficiency in MS Office, CAD (SolidWorks), 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)

Competencies

1. Technical & Engineering Excellence

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

1. Validation & Quality Mindset

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

1. Project Ownership & Execution

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

1. Continuous Improvement & Lean Thinking

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

1. Collaboration & Communication

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

1. Business & Cost Acumen

• Level I: Understands basic cost drivers and supports cost tracking
• Level II: Analyzes COGS and implements cost reduction strategies

1. Problem Solving & Decision Making

• Level I: Uses structured problem-solving with guidance
• Level II: Leads root cause analysis and implements sustainable corrective actions

Measurement of Performance

• Execution of projects on time and within scope
• Quality and compliance of validation and engineering documentation
• Contribution to process improvements and cost savings
• Effectiveness in cross-functional collaboration and communication
• Customer satisfaction and responsiveness
• Demonstrated growth in technical capability and ownership

Physical Demands of Position

The physical demands described are representative of those required to successfully perform the essential functions of this role. Reasonable accommodations may be made.

This position requires sitting, standing, and use of hands for computer and laboratory tasks. The role operates in both laboratory and manufacturing environments with variable conditions. Effective communication (verbal and written) and standard vision/hearing capabilities are required.