Job Title: Senior Product Development Engineer - Medical Devices
Description:
We are seeking a highly skilled Senior Product Development Engineer to join our team at Wallace Myers International. As a key member of our R&D department, you will be responsible for leading the development of novel medical devices from concept to delivery.
Main Responsibilities:
* 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.
Key Deliverables:
* Testing, analysis, and development of design concepts for novel medical devices through:
o Building prototypes to prove concept effectiveness.
o Creating test methods to accurately and repeatably demonstrate safety and effectiveness.
o Predicting design outcomes through mathematical calculations, digital analysis, and physical design experimentation.
o Utilising user testing groups to test product designs in the real world, documenting insights and iterating on concepts.
Project Management:
* 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.
Leadership and Collaboration:
* Providing technical leadership and mentoring to less experienced team members.
Personal Attributes:
* A proactive team player who seeks to help develop your teammates.
* Outstanding in written and verbal communication and collaboration skills.
* A sense of urgency in your work, resourceful and independent, and thriving when taking responsibility for tasks.
* Able to prioritise your list of tasks independently and ensure actions are completed on time.
* A creative problem solver who is enthusiastic about new ideas.
Experience Requirements:
* At least 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.
* A 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.
Desirable Experience:
* 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 experienced in using machined prototypes. Good benchtop skills for manufacturing prototypes.
About Us:
Wallace Myers International Recruitment Agency specialises in sourcing professionals for key industries and services.