Mechanical Engineer
Description
Onera is hiring a Mechanical Engineer responsible for the mechanical design and development of our medical devices, from early concepts through verification, industrialization and transfer to manufacturing. You will work closely with Electronics, Firmware, Systems, Clinical, Quality and Product teams to create robust, manufacturable and clinically suitable products. You will also work with external suppliers and manufacturing partners to ensure that designs can be reliably produced at scale.
A key part of the role is design transfer to manufacturing: translating engineering designs into production-ready products, working with manufacturing partners on DFM/DFA, resolving production issues and ensuring that changes are properly controlled within our medical device development processes.
About Onera Health
Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring a variety of chronic conditions, ultimately improving the health and quality of life for patients around the world. The company’s innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimise patient care and reduce healthcare costs.
What you will do
Lead mechanical design and development of medical device components, assemblies and enclosures from concept to production.
Create and maintain 3D CAD models, drawings, specifications and mechanical design documentation.
Design for manufacturability and assembly (DFM/DFA), considering scalability, cost, quality and reliability.
Work with suppliers and contract manufacturers on prototypes, tooling, production processes and design transfer.
Support verification and validation activities, including defining and executing mechanical tests.
Drive resolution of mechanical design and manufacturing issues through root-cause analysis and engineering problem solving.
Support production ramp-up and continuous improvement of existing products.
Collaborate with Systems Engineering and other disciplines to ensure mechanical designs meet system-level requirements.
Contribute to risk management, design reviews and technical documentation within our medical device design control process.
Manage mechanical engineering deliverables, timelines and technical decisions within multidisciplinary development projects.
Support supplier selection, technical discussions and qualification of components and manufacturing processes.
Contribute to design changes and product improvements throughout the product lifecycle.
What you bring
Must have
Bachelor's or Master's degree in Mechanical Engineering or a related engineering discipline.
5+ years of relevant experience in mechanical product development, preferably in medical devices, consumer electronics, wearables or another highly regulated/high-volume product environment.
Strong experience with mechanical design and 3D CAD.
Solid understanding of materials, manufacturing processes, tolerances and mechanical testing.
Practical experience with design for manufacturing and assembly (DFM/DFA).
Experience taking products from engineering development into manufacturing and production.
Experience working directly with suppliers and contract manufacturers.
Strong problem-solving skills and a hands-on engineering mindset.
Experience working in multidisciplinary development teams.
Good understanding of product development processes and configuration/change management.
Nice to have
Experience with medical device development and design controls, preferably within an ISO 13485 environment.
Experience with design transfer, production ramp-up and manufacturing process qualification.
Experience with injection moulding, overmoulding, CNC machining, adhesives, textiles or other relevant manufacturing technologies.
Experience designing wearable or skin-contacting products.
Experience with tolerance analysis and GD&T.
Experience with reliability engineering and environmental/mechanical testing.
Familiarity with risk management according to ISO 14971.
Experience working with external manufacturing partners in Europe or Asia.
How you work
You are an engineer who enjoys turning ideas into real products. You are comfortable moving between detailed technical work and broader system-level discussions.
You take ownership, challenge designs when necessary and work pragmatically towards solutions. You are equally comfortable developing a prototype yourself, discussing manufacturability with a supplier, and presenting a technical decision to a multidisciplinary team.
You thrive in a scale-up environment where priorities can move quickly and where your work has a visible impact on the product.