Key Skills

Job Description

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

Core Responsibilities

Lead the transfer of new and revised products into volume manufacturing with external partners, defining and validating processes, tooling, work instructions, and training. Analyze production data, resolve manufacturing issues, improve yield and quality, and ensure supplier processes meet regulatory and quality requirements.

Requirements

Requires a bachelor's degree in engineering or a related technical field and 8+ years of NPI, manufacturing, process, or industrialization engineering experience, including work in a regulated environment. Candidates should have experience with contract manufacturers, electromechanical products, SMT and electronics assembly, production data analysis, and supplier collaboration, and be available for frequent travel including to Asia.