Lead NPI Engineer - Medical Device Manufacturing & Transfer

Onera Health Inc.; Eindhoven; On-site; EUR 90,000 - 120,000; Full time

Job summary

Onera Health Inc. seeks a Senior NPI Engineer to transfer products from development into reliable, repeatable manufacturing with external partners. You will bridge R&D and contract manufacturers, set up manufacturing capability, and drive process qualification and supplier collaboration.

This hands-on, data-driven role requires strong root-cause analysis, cross‑functional teamwork, and willingness to travel to Asia as needed to scale manufacturing.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 8+ years' experience in an NPI, manufacturing, process or industrialisation engineering role.
• Experience in medical devices or another regulated environment with working knowledge of medical device manufacturing regulatory requirements.
• Proven experience working with third-party manufacturers, contract manufacturers or EMS providers.
• Experience setting up manufacturing capability for electromechanical devices or products.
• Working knowledge of SMT and electronics assembly processes, final assembly and part manufacturing processes.
• Strong analytical capability: able to read production data, draw conclusions and lead structured root cause analysis.
• Able to work independently across time zones and cultures, and to influence supplier teams you do not manage.
• Willing and available to travel frequently, including to Asia.

Responsibilities

• Lead the transfer of new and revised products from development into volume manufacturing at external partners.
• Define, validate and document manufacturing and assembly processes, including process capability, test coverage and yield targets.
• Support design for manufacturability, working with R&D so that products are designed to be built at scale.
• Set up manufacturing capability at the supply side: process definition, tooling, line layout, work instructions and operator training.
• Work day to day with Onera's primary manufacturing partner in Asia, and with additional third-party manufacturers and EMS providers.
• Mentor and guide partner engineering teams on process technology.

Skills

Root cause analysis

Data-driven

Process capability

SMT

Electronics assembly

Education

Bachelor's degree in Engineering

Tools

ISO 13485

FDA 21 CFR Part 820

Job description

Onera Health Inc. seeks a Senior NPI Engineer to transfer products from development into reliable, repeatable manufacturing with external partners. You will bridge R&D and contract manufacturers, set up manufacturing capability, and drive process qualification and supplier collaboration.

This hands-on, data-driven role requires strong root-cause analysis, cross‑functional teamwork, and willingness to travel to Asia as needed to scale manufacturing.