Senior R&D Engineer- startup

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• Contributing to technical reviews, interpreting data from experimental work, and influencing design direction through product brainstorms.
• Developing concepts through to manufacture-readiness using techniques such as vacuum-forming, injection moulding, dip moulding, and blow moulding, among others.
• Leading the completion of tasks and projects through a methodological and planned approach to product development.
• Exploring and vetting materials, components, and suppliers.
• Communicating design decisions, interpreting literature and test results, and influencing design direction.
• Generating new design ideas and concepts that meet the overarching design requirements.

Testing, analysis, and development of design concepts for novel medical devices through:

• Building prototypes to prove concept effectiveness.
• Creating test methods to accurately and repeatably demonstrate safety and effectiveness.
• Predicting design outcomes through mathematical calculations, digital analysis, and physical design experimentation.
• Utilising user testing groups to test product designs in the real world, documenting insights, and iterating on concepts.

Take responsibility for the delivery of project goals in a timely fashion by:

• Taking personal responsibility for critical and complex technical tasks.
• Working closely with the R&D Lead, Project Manager, and RA/QA team to maintain agreed timelines and ensure quality standards are maintained.
• Ensuring the delivery of projects in a timely fashion by working closely with, guiding, and building relationships with external suppliers and manufacturing partners, managing their time effectively and maintaining agreed timelines.
• Providing technical leadership and mentoring to less experienced team members.

Personal Attributes - The Ideal Candidate Is:

• Open: A proactive team player who seeks to help develop your teammates. You are willing to adopt, engage with, and shape company culture in a positive manner. You can give and receive candid feedback in a constructive and positive manner.
• Communicative: Outstanding in written and verbal communication and collaboration skills. You are able to articulate ideas clearly and support ideas with evidence.
• Self-Driven: You have a sense of urgency in your work, are resourceful and independent, and thrive when taking responsibility for tasks.
• Organised: You can prioritise your list of tasks independently and ensure actions are completed on time.
• Creative: A creative problem solver who is enthusiastic about new ideas.

Experience Requirements - The Ideal Candidate Must Have:

• Worked on several product design or development projects, with 6 years of experience in an R&D role and at least 4 years of experience in the medical device sector.
• Experience with directly contributing to Design History File documents such as Design Inputs, Test Method Design and Validation, and Design Verification Plans alongside experience writing formal testing protocols and test reports.
• Clear ability to create robust tests for evaluating designs, predicting outcomes, and determining iteration requirements.
• Experience working towards and carrying out Design Verification testing.
• A strong understanding of medical device regulatory requirements and applicable standards.
• An ability to demonstrate a methodological and planned approach to product development.
• Experience working within a Quality Management System to ISO13485 standards.

Experience Advantages - It Would Be Advantageous to Have:

• Demonstrable examples of design for assembly/manufacture experience.
• Knowledge of a wide variety of manufacturing processes, such as injection moulding, vacuum casting, dip moulding, joining technologies, and rapid prototyping (3D printing).
• Experience working with wearable products that involve textiles.
• CAD experience (we use CREO, but we can provide training), general modelling, and drafting 2D drawings.
• Prior experience designing and executing usability studies and incorporating human factors considerations into the product design.
• Comfortable with rapid prototyping using FDM, SLS, and SLA 3D printing. Can demonstrate understanding of the limitations of rapid prototyping and is experienced in using machined prototypes. Good benchtop skills for manufacturing prototypes.

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