My client who are a growing Medical Device start-up are looking to hire a Senior R&D Engineer.
You will be part of a team bringing a device from proof-of-concept phase through to a market - ready product.
Overview: Contributing to technical reviews, interpreting experimental data, and influencing design direction through brainstorming sessions.
Developing concepts from early prototypes to manufacturing readiness using techniques such as vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, and 3D printing.
Leading tasks and projects with a structured, methodical approach to product development.
Evaluating and sourcing materials, components, and suppliers to ensure optimal design and manufacturability.
Communicating design decisions effectively, interpreting research literature and test results to refine and improve designs.
Creating and maintaining design documentation, including drawings, specifications, technical reports, user needs, product requirements, and traceability matrices.
Collaborating with design assurance to conduct risk assessments through FMEAs.
Working with manufacturing engineers to ensure DFA throughout design Building prototypes to validate design concepts.
Developing and implementing test methods to ensure safety and effectiveness.
Predicting design outcomes through mathematical modelling, digital analysis, and experimental validation.
Utilising user testing groups to gather real-world insights and iterate on designs.
Working with the V&V engineer to validate test methods for design verification.
Requirements: 6+ years of R&D experience, including 4+ years in the medical device sector, working on multiple product design and development projects.
Expertise in Design History File (DHF) documentation, including Design Inputs, Test Method Design & Validation, and Design Verification Plans.
Hands-on experience in design for assembly/manufacturing, with knowledge of injection moulding, vacuum casting, dip moulding, joining technologies, and rapid prototyping (3D printing).
Proven ability to develop robust test methods for evaluating designs, predicting outcomes, and guiding iteration and carrying out Design Verification testing.
Strong understanding of medical device regulatory requirements, including FDA guidance, MDR, ISO 13485, and IEC 60601.
Familiarity with Quality Management Systems (ISO 13485) and compliance with industry standards, in particular FDA guidance, MDR guidance, ISO 13485 and IEC 60601.
Methodical and structured approach to product development.
It Would Be Advantageous to Have: Experience working with wearable products that involve textiles.
CREO CAD experience.
Experience in design for sterilisation.
Experience testing autoinjectors and/or vascular access devices.
Prior experience designing and executing usability studies and incorporating human factors considerations into the product design.
Experience with design for electromechanical and pneumatic devices.
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For more info see Skills: R&D Medical Device Product Development AutoCad Solidworks