WearOptimo is a biotechnology ‘skunkworks’ with the mission of advancing wearable healthcare sensing toward clinical outcomes. Our minimally-invasive and pain-free devices are applied to the skin, accessing key signals/information in the body. Our high-performance, interdisciplinary team comes from around the world, with expertise in technology, science and commercial sectors. We are united in our passion and commitment to help tackle important healthcare challenges with practical solutions.
WearOptimo is now at a critical stage of growth and essential to continued evolution and success is the appointment of an exceptional Senior Medical Product Electrical Engineer.
A leader in the medical product development team, the Senior Medical Product Electrical Engineer leads and is responsible for the definition, design, and development of advanced electrical wearable diagnostic sensor products. Responsible for the development and qualification of electronics and electrical components, manufacturing processes, safety certifications, product delivery and assist in the regulatory approval of a medical device. As a Senior engineer you will be responsible for project execution, leadership of engineers within the project and documentation to support regulatory approval of a medical device under an ISO-13485 quality management system.
From an operational and delivery perspective, the Senior Medical Product Electrical Engineer will:
- Own and deliver the development, process characterization and validation of the electrical components and assembly process for new wearable medical product development (NPD) projects. Lead scale-up understanding from the Concept Stage to Proof of Principle of engineering unit operations.
- Own test, development, error proofing and qualification, create process flow charts, FMEAs and control plans for a new electrical medical product and participate in technical design reviews. Create system and sub-system product requirements, hazard analysis and risk mitigation of a regulated class II medical product.
- Own the inputs for related activities on scaling up to manufacturing (prototypes, build, tooling and validation) within the NPD project plan and successfully transfer knowledge to manufacturing of unit operations enabling transition to production. Ensure successful integration and start-up of manufacturing lines and tooling to yield electrical components, sub-assemblies and products that meet design specifications.
- Collaborate with the design team to provide DfX (manufacturing, assembly, cost, testing etc.) input and enable translation of product design inputs to product and process outputs, supplier selection, project and product risk management and design & process transfer to manufacturing.
- Work with cross-functional teams including R&D, Product Development, Manufacturing, Quality and Regulatory Affairs to ensure project success and product commercial launch.
- University degree in electrical engineering or equivalent.
- Proven commercial experience in the electrical development of class IIA/IIB or class III medical devices.
- Relevant experience in the electrical development of regulated medical products
- Strong Experience working to ISO 13485 Quality Management Systems and demonstrated experience of applying IEC standards and technical regulations to medical products for testing and certification.
- Demonstratable medical product trial planning, implementation and analysis.
- Strong Experience with preparing validation and verification reports and associated engineering documents and design documents.
- Demonstratable technical leadership, driving complex electrical medical products to manufacturing and to market under accelerated timeframes.
- Ability to successfully collaborate with technical and non-technical staff
- A team player that can also ensure individual workload is successfully delivered
- Proven problem-solving ability and enjoys learning and applying new skills
- Strong autonomous background and ability to self-manage time and tasks
- Ability to work under pressure and time constraints
- Commercial acumen, resilience and a flexible approach to dealing with changing priorities and demands