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 Development Engineer.
A leader in the product development team, the Senior Medical Product Development Engineer leads and is responsible for the definition, design, and product development of advanced wearable diagnostic sensor products. Responsible for the development and qualification of hardware and device components, manufacturing processes, safety certifications, product delivery and assist in regulatory approval of a medical device. As an SNR Engineer, you will be responsible for project execution, the 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 Development Engineer will:
- Own and deliver the development, process characterization and validation of the mechanical components and assembly process for new wearable medical product development (NPD) projects. Lead scale-up understanding from Concept 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 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 the manufacturing of unit operations enabling the transition to daily production. Ensure successful integration and start-up of manufacturing lines and tooling to yield hardware 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 the 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.
To be successful in this role you will have experience as a Senior Medical Product Development Engineer role within a similar company. You will have experience across the following:
- University degree in engineering or equivalent.
- Proven commercial experience in the product development of class IIA/IIB or class III medical devices.
- Relevant experience in the product development of regulated medical products.
- Strong Experience working to ISO 13485 Quality Management Systems and demonstrated experience in applying ISO 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 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