We are seeking an R&D/Product Development Engineer to join our team. This role is responsible for product and process development of minimally invasive catheter shafts from feasibility through to transfer to operations and commercial release.
Job Overview
The successful candidate will work with a project team on New Product Design (NPD) opportunities taking products from concept to production. They will possess experience in process engineering, a good understanding of catheter shaft manufacturing processes, and the ability to work as part of a cross-functional team.
Responsibilities
1. Process Development: Be an integral part of the team tasked with the development of catheter shafts from concept through to process validation and transfer to operations.
2. Process Optimization: Work with Technical leaders to continuously evaluate and improve existing processes to enhance productivity, quality, and cost-effectiveness while maintaining compliance with industry standards and regulations.
3. Cross-Functional Collaboration: Work closely with PMO, Operations, Quality, and other departments to ensure smooth handoffs and successful process development and implementation.
4. Customer engagement: Build a partnership with customers and support technical content during customer calls and visits.
5. Troubleshooting: Work with a team to address technical issues during feasibility, development, validation, scale-up, and manufacturing, providing solutions to design and process challenges.
Requirements
* Qualifications: Level 8 Engineering, Science, or equivalent degree.
* Experience: 5+ years industry experience in a Medical NPD environment.
* Key Requirements:
o Demonstrated proficiency in catheter shaft manufacturing techniques including braiding, coiling, reflow, and thermal/adhesive bonding.
o Proven ability to conduct and contribute to FMEAs, verifications, and validations for medical device products and processes.
o Working knowledge of biocompatible metal and polymer materials.
What We Offer
* A competitive salary package.
* Performance-based bonus plans.
* Health and wellness incentives.
* Employee stock purchase program.
* Community outreach programs/charity events.
* Employee resource group.