Senior R&D Engineer
About the Role:
Our Client, a cutting-edge medical device company based in Galway, is hiring a Senior R&D Engineer to lead product development from concept through to manufacturing readiness.
Responsibilities:
* Product Development and Design:
o Lead product development ensuring products are safe, effective, and user-focused.
o Contribute to technical reviews, interpret experimental data, and influence design direction.
o Develop prototypes and refine designs using various techniques such as vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, and 3D printing.
o Evaluate and source materials, components, and suppliers to optimize design and manufacturability.
o Communicate design decisions clearly and interpret research literature and test results to enhance product designs.
o Create and maintain comprehensive design documentation, including drawings, specifications, technical reports, user needs, product requirements, and traceability matrices.
* Testing, Analysis, and Development:
o Build prototypes to validate design concepts and ensure safety and effectiveness.
o Develop and implement test methods for product safety and performance validation.
o Predict design outcomes through mathematical modelling, digital analysis, and experimental validation.
o Utilize user testing groups to gather real-world insights and iterate on designs.
o Collaborate with the Verification & Validation (V&V) engineer to validate test methods for design verification.
* Quality Assurance and Compliance:
o Collaborate with design assurance teams to conduct risk assessments using Failure Mode and Effects Analysis (FMEA).
o Ensure all product designs comply with relevant regulatory standards, including FDA guidance, MDR, ISO 13485, and IEC 60601.
o Maintain Design History File (DHF) documentation, including Design Inputs, Test Method Design & Validation, and Design Verification Plans.
* Project Leadership and Execution:
o Take ownership of critical and complex technical tasks, driving project success and maintaining timelines.
o Collaborate with the R&D Lead, Project Manager, and RA/QA teams to ensure project alignment and uphold quality standards.
o Manage external suppliers and manufacturing partners, ensuring timely delivery and alignment with project goals.
o Provide technical leadership and mentorship to junior team members, fostering growth and expertise within the team.
Requirements:
* Experience and Expertise:
o Minimum of 6+ years of R&D experience, with at least 4+ years in the medical device sector.
o Proven track record in product design and development, including design for assembly/manufacturing.
o Expertise in Design History File (DHF) documentation and Design Verification Plans.
o Hands-on experience with manufacturing processes such as injection moulding, vacuum casting, dip moulding, and rapid prototyping (3D printing).
o Strong understanding of medical device regulatory requirements, including FDA guidance, MDR, ISO 13485, and IEC 60601.
* Technical Skills:
o Proficiency in developing robust test methods for evaluating designs and guiding iterations.
o Familiarity with Quality Management Systems (ISO 13485) and compliance with industry standards.
o Experience with risk assessments using Failure Mode and Effects Analysis (FMEA).
* Leadership and Collaboration:
o Proven ability to lead cross-functional teams and collaborate effectively across departments.
o Experience in managing external suppliers and manufacturing partners.
o Strong communication and collaboration skills, with the ability to convey complex technical concepts clearly.
* Personal Attributes:
o Creative: Problem solver with enthusiasm for exploring innovative solutions.
o Open and Collaborative: Team player who actively contributes to a positive company culture.
o Communicative: Proficient in written and verbal communication, able to articulate ideas effectively.
o Self-Driven and Organized: Highly motivated with a sense of urgency and the ability to manage multiple tasks.
o Methodical Approach: Structured and analytical in problem-solving and product development.
Preferred Qualifications:
* Experience working with wearable products involving textiles.
* Proficiency in CREO CAD software.
* Experience in design for sterilization.
* Familiarity with testing autoinjectors and/or vascular access devices.
* Prior experience designing and executing usability studies, incorporating human factors into product design.
* Experience with electromechanical and pneumatic device design
Note:
By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.