Senior Manufacturing Engineer (Location: Galway, Ireland)
As senior manufacturing engineer at WhiteSwell, you will transform concept into reality by leading set-up, verification, validation and scaling of manufacturing of a leading-edge device therapy for patients with acute decompensated heart failure. You communicate well with multi-disciplinary teams, maintaining a commitment to delivering high quality devices within the targeted timeframe.
Join WhiteSwell, a dynamic, rapidly growing organisation, as we seek to fundamentally shift treatment of acute decompensated heart failure by harnessing the vital role of the lymphatic system in restoring fluid balance.
What you’ll do:
- Provide broad technical leadership and guidance to the business in the fields of process technology, assembly, manufacturing, and scaling operations. Drive the execution of the technical operations strategy in the business. Build capabilities, develop technical core competencies and ensure adherence to world class principles in the development and scaling processes of the business (Design for Manufacture & Assembly, LEAN etc).
- Identify, evaluate, manage, and provide technical guidance to suppliers, including establishing tolerances and defining acceptance criteria related to materials, manufacturing processes, and design.
- Manage external relationships with technology and component providers. Evaluate, with the R&D team, the design and supply chain risks in the project and develop strategies to highlight, monitor, manage and mitigate these risks.
- Lead design to manufacturing transfer activities. Identify and enhance product and process variables to maximize performance at prototype, pilot, and production stages.
- Oversee and implement component, process, test, and design validation methodologies, protocols and reports.
- Ensure that high quality product is delivered, and that the supply chain runs smoothly and efficiently.
What you bring:
- A BSc or MSc in biomedical, mechanical, materials or industrial engineering.
- 5+ years engineering experience working with a breadth of catheter technologies and processes. Proven track record managing a MedTech R&D project from concept to the clinic
- Experience in the development and production of medical devices that require complex processes and assembly techniques and a proven ability to deliver results in this setting.
- Excellent written, interpersonal communication and presentation skills.
- High level of self-motivation, proactive attitude, and sense of ownership and personal responsibility
- Lead by example to build a positive, supportive, respectful culture that motivates and enables the team to accomplish strategic objectives.