Description

The Senior NPI Engineer owns the transfer of Onera's products from development into reliable, repeatable manufacturing at external partners. Sitting within the Manufacturing & Operations team, this role is the technical bridge between Onera's R&D engineers and the contract manufacturers who build the product.

Assembly of Onera’s product is generally outsourced, with a primary manufacturing partner in Asia and additional third-party suppliers. That makes this a build role rather than a maintain role: you will be setting up manufacturing capability on the supply side, defining and qualifying processes, and raising the technical capability of partners who are new to Onera's product.

This is a hands-on, data-driven engineering role for someone who reads process data, finds root cause, and anticipates the problem before it reaches the line.

About Onera Health

Onera Health is a leader in transforming sleep medicine and remote monitoring. Our breakthrough diagnostic solutions are designed to help the millions of people living with sleep-related conditions, and to support the monitoring of chronic disease — improving patient outcomes around the world.

Onera’s FDA-cleared and CE-marked home polysomnography (hPSG) platform brings clinical-grade sleep diagnostics out of the sleep lab and into the patient’s home, using wireless, patient-applied patches.

What you will do

New product introduction 

• 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

Manufacturing partners and supply-side capability 

• 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 — SMT and electronics assembly, gluing and bonding processes, screen printing, injection moulding, and final assembly

• Act as the technical point of contact for manufacturing issues, escalations and change requests

Process control and problem solving 

• Read and interpret production data to draw conclusions, identify trends and drive root cause analysis

• Anticipate emerging manufacturing risks and resolve them before they affect quality, yield or delivery

• Drive corrective and preventive actions through to closure with suppliers

• Deliver continuous improvement in yield, cycle time, cost and first-pass quality

Quality and regulatory 

• Ensure manufacturing processes meet medical device regulatory requirements and Onera's quality management systemEnsure manufacturing processes meet medical device regulatory requirements and Onera's quality management system

• Produce and maintain process validation documentation (IQ/OQ/PQ), risk assessments and change control records

• Support supplier audits and qualification activities

What you bring

Must have

• 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

Nice to have

• Hands-on experience with gluing and bonding processes, injection moulding, or other polymer and part manufacturing processes

• Experience transferring a product from prototype to volume manufacturing in Asia

• Experience with battery operated, wearable, miniaturised or sensor-based devices

• Familiarity with ISO 13485 and FDA 21 CFR Part 820

• Six Sigma, Lean or equivalent structured problem-solving training

• Experience in a scale-up or high-growth environment, where processes are built rather than inherited