Senior R&D / Product Development Engineer
We are seeking a highly skilled Senior R&D/Product Development Engineer with expertise in product and process design, process optimization and scale-up.
Salary:
$120,000 - $180,000 per year (estimated)
About the Role
Job Responsibilities:
* Lead and be an integral part of the team tasked with the development of catheter shafts from concept through to process validation and transfer to operations
* Continuously evaluate and improve existing processes to enhance productivity, quality, and cost-effectiveness while maintaining compliance with industry standards and regulations
* Work closely with PMO, Operations, Quality, and other departments to ensure smooth handoffs and successful process development and implementation
* Build a partnership with, and lead technical content during customer calls and visits
* Address technical issues during feasibility, development, validation, scale-up and manufacturing, providing solutions to design and process challenges
* Prepare detailed documentation in line with project needs, regulatory requirements and industry standards
* Drive continuous improvement initiatives, contributing to the development of new technologies, methodologies, and solutions to meet business goals
* Provide guidance and mentorship to junior engineers and cross-functional teams, fostering a culture of innovation and collaboration
Requirements:
* Qualifications Level 8 Engineering, Science or equivalent degree
* 5+ years industry experience in a Medical NPD environment
* Experience with Lean Six Sigma, Design of Experiments (DOE), or other process optimization methodologies
* Proven expertise in key catheter shaft manufacturing techniques Braiding, coiling, reflow, thermal and adhesive bonding at minimum
* Excellent problem-solving and troubleshooting skills
* Proven experience in leading teams performing FMEAs, verifications and validations for medical device products and processes
* Experience with engineering tools such as DOE, SPC, and using Minitab
* Working knowledge of biocompatible metal and/or polymer materials
* Strong interpersonal and communication skills, both written and verbal, with the ability to steer cross-functional teams
* Ability to lead a team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities
* Ability to present technical information clearly to both technical and non-technical stakeholders
About Us
The position will be based in our Medical HQ in Galway. Our NPD Engineering Teams are responsible for product and process development of minimally invasive catheter shafts from feasibility through to transfer to operations and commercial release;
The NPD team engage with customers to understand the user needs and requirements and work with customer to deliver the solution.