Senior Project Engineer – Dublin
This is an excellent opportunity to join a leading medical device multinational. If you are experienced in leading the design and development of medical device products through to full life cycle.
- Ensure relevant and innovative product development solutions.
- Responsible for successful and timely completion of designated tasks.
- Application of Design for Manufacturing/Assembly (DFM).
- Define tolerance stack-up analysis for complex mechanical assemblies.
- Investigate mechanical errors in device performance.
- Provide guidance for FEA analysis.
- Lead development of appropriate test plans to fully characterize devices under development.
- Conduct design reviews, FMEA’s and design verification programs.
- Prepare technical documentation.
- Manage and assess external vendors/supplier work and capabilities
- Support design validation and process validation programs.
- Maintain DHF with mechanical design deliverables and lead device design transfer and manage post approval device changes.
- Define control strategy for the finished product.
- Support regulatory submissions and approvals.
- Support post approval regulatory submission.
- Lead technical aspects for managing marketed product changes.
- Collaborate with multidisciplinary team to develop pipeline products and to support launch market support globally.
- BSc. in Mechanical Engineering, Biomedical Engineering, Engineering Technology or relevant.
- 8+ years’ experience in the development and registration of medical devices.
- Experience of working with GMP, international device regulations and design controls.
- Understanding of product development considerations for tightly controlled, high-volume manufacturing processes.
- Experienced driving the design of plastic components.
- Excellent problem solving methodology, using industry accepted concepts and tools.
Ability to develop relationships and collaborate across the team.
- Some international travel required.
- Must be authorised to work in Ireland.
- Knowledge Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
- Strong materials background.
- Extensive experience with Solidworks or other CAD software.
- Experience in project management.
Please contact Mary-Ann Keena to learn more
+353 (0) 83 0220666