NPI Design Transfer Engineer

NeuWave Medical Inc.; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

NeuWave Medical Inc. seeks a Development Engineer to move released designs from R&D into production, ensuring outputs are complete, manufacturable, and verifiable for manufacturing.

You will partner with design engineers early to provide manufacturability input and own the transfer documentation package through completion. You will lead design transfer activities, confirm drawings, BOMs, specifications, and work instructions are production ready, and coordinate handoffs to Operations and

Qualifications

• BS in Mechanical, Biomedical, Manufacturing, or related engineering field.
• 3–7 years of engineering experience in medical devices or regulated industry.
• Knowledge of design controls and quality system requirements (ISO 13485, FDA QMSR).
• Experience with engineering drawings, GD&T, BOMs, and change control.
• Familiarity with process or test method validation concepts.
• Experience writing and executing verification or validation test protocols, and familiarity with requirements management and traceability.
• Clear written communication and the ability to manage several workstreams.

Responsibilities

• Lead design transfer for assigned projects, including creating and maintaining transfer plans, checklists, and transfer reports.
• Confirm design outputs (drawings, BOMs, specifications, work instructions, inspection and test methods) are complete and suitable for manufacturing before they become production specifications.
• Coordinate handoffs to Operations, Quality, Supply Chain, and external suppliers, and close open transfer items.
• Support pilot and first production builds, documenting issues and driving them to resolution.
• Participate in design reviews and provide independent DFM/DFA feedback on design inputs and outputs, before freeze where possible.
• Develop and execute design verification test protocols and reports, including test method development and fixture design.
• Maintain traceability between requirements, design outputs, and verification evidence in the design history file.

Skills

Written communication

Multitasking

Design transfer experience

Education

BS in Mechanical/Biomedical/Manufacturing engineering

Tools

CAD

PLM

eQMS

Job description

NeuWave Medical Inc. seeks a Development Engineer to move released designs from R&D into production, ensuring outputs are complete, manufacturable, and verifiable for manufacturing.

You will partner with design engineers early to provide manufacturability input and own the transfer documentation package through completion. You will lead design transfer activities, confirm drawings, BOMs, specifications, and work instructions are production ready, and coordinate handoffs to Operations and