Job description
embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com.
The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the emebcta organisation, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across operations, engineering, quality and R&D.
We are recruiting for a Senior Product Engineer to join our R&D team at our Dun Laoghaire site.
About the role
As a Senior Product Engineer, you will;
- Demonstrate technical leadership and project management capabilities, to plan and execute R&D projects which impact key R&D strategic deliverable. Projects will result in the design, development or refinement of diabetes care devices, specifications, materials, test methods and/or equipment.
- Completing design verification and validation activities, including protocols and reports and product testing.
- Lead complex problem-solving efforts and identify root causes associated with product form, fit or function.
- Capability of drawing conclusions and making recommendations based on technical design inputs and statistical analysis.
- Collaborate and act as technical expert to support quality, regulatory, commercial, and manufacturing colleagues.
- Support the global roll out and commercialization of products through regulatory submissions.
- Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape.
- Communicate, present, and escalate project achievements and risk to senior management and to cross functional stakeholders.
- Ensure compliance with international standards and internal quality, safety and regulatory, procedures.
- Utilise best practices such as test method validation, Gage R&R, and/or DOE to design and implement new test equipment.
- Manage, coach and mentor junior engineers and technicians as appropriate.
Experience & Education
- Must have a bachelor’s degree in Engineering, preferably in Mechanical, Biomedical, or Chemical Engineering.
- 6+ years’ experience in medical device design or R&D with a successful track record of delivering products to market and successfully supporting products in the market after launch.
- The stage gate processes and design controls used in medical product development.
- Project planning and management of cross-functional teams.
- Solidworks CAD experience (GD&T preferred).
- Test method development and validation.
- Strong organizational, communication, and collaborative skills.
- Fixture creation & development and test method development, implementation and validation (Gage R&R) for medical device/systems.
- Statistical concepts such as those used in MSA, DOE, and TMV’s.
- Experience with laboratory test equipment.
- Iterative design and development experience via prototyping and hands on experimentation.
- Quality management systems in a regulated environment.
- Ability to travel domestically and internationally 10 - 15%
Click on apply if this sounds like you! For more information, visit embecta.com.
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