Job Overview:
As a key member of the product development team, you will work closely with engineers and cross-functional teams to design, develop, and deliver innovative medical devices.
You will be responsible for providing technical support to ensure safety, compliance, and manufacturing continuity of our product portfolio, which includes Balloon Catheters, Stent Delivery Systems, Cutting Balloons, and Drug Coated devices.
A key part of your role will be to establish/verify performance standards for products, processes, materials, and create/maintain design-related technical documentation and design history.
Key Responsibilities:
1. Collaborate with project teams to contribute to product design and development, product design changes & troubleshooting, test method development & validation, testing & characterization of materials, development & assessment of specifications, research investigations, data analysis, report preparation, etc.
2. Responsible for design-related documentation, including prints and specifications.
3. Demonstrate knowledge of design control & PLCP through generation of high-quality deliverables.
4. Use systematic change process to ensure proposed changes are thoroughly analysed before beginning the change process.
5. Maintain product performance through Quality Investigations and ensuring rigorous support for design changes.
6. Design and coordinate product testing and experiments.
7. Summarize, analyze, and draw conclusions from test results.
8. Perform troubleshooting on products/process problems related to design, material, or process.
9. Prepare reports/documentation to communicate results to the technical community.
10. Interpret evolving global regulatory requirements and assess impact to product design.
11. Work cross-functionally and cross-site with project management, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
12. Collaborate with manufacturing to reduce product costs through design improvements.
13. Interface with vendors and physicians where projects require.
14. Work independently to plan and schedule own activities necessary to meet timelines.
15. Work under minimal direction regarding the progress of projects and special assignments.
16. May seek guidance in resolving problems, interpreting established policies, procedures, and practices.
17. May train and/or provide work direction to technicians and interns.
18. Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary organisation.
19. Demonstrate a primary commitment to patient safety and product quality.