Lead Mechanical Design Engineer

2 weeks ago

Bray, Wicklow, Ireland Jabil Full time
Jabil Lead Mechanical Design Engineer in Bray, Ireland

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

The Lead Design Engineer is responsible for leading the design, development and verification of complex medical devices. Apply knowledge from mechanical, mechatronic, electronic and manufacturing background to develop medical devices, prepare product specifications, develop product assembly solutions and develop testing requirements to meet regulatory submissions. Lead and manage cross-organizational effort to design, develop and implement robust designs with proper verification, and design for manufacturability for seamless product introduction. Systematic analysis of complex technical data to understand device function and root cause device failures.

Key Responsibilities
  1. Leads and manages design, development and verifies complex assemblies and sub-assemblies, components, and packaging as assigned. Identifies material, process, tooling, automation and equipment selection.
  2. Manages Definition of Product Requirements into Product Specifications.
  3. Leads evaluation of product specifications through engineering study and proof of concept testing.
  4. Develops and implements changes to existing product design and/or the manufacturing process to achieve performance, quality, and cost improvements.
  5. Leads product and manufacturing Risk Assessment / Analysis documentation (PHA, FTA, dFMEA / uFMEA).
  6. Analyses data and conducts failure investigations in order to determine causes of problems and develop & implement solutions.
  7. Works with manufacturing to trouble-shoot problems, upgrades, retrofits, set-ups, methods development and the development of process parameters.
  8. Leads projects/sub-sections of large projects and cross functional teams. Assigns and manages task of other engineers or technicians assigned to the project.
  9. Applies a structured project management approach to all deliverables, involving key stakeholders with ability to communicate effectively both internally and externally.
  10. Researches new technology or development tools to remain informed of current technology.
  11. Responsible for the employment cycle, performance and compensation management, and training and development for assigned direct reports.
  12. Coordinate, lead and supervise the daily activities of the team.
  13. Set priorities to ensure tasks are completed.
  14. Provides technical support to key vendors / sub-contract manufacturers.
  15. Leads technical meetings and presentations both internally and with external customers.
  16. Provides guidance and input with developing new customer proposals.
  17. Input to Q Lock Reviews.
  18. Ensures projects are compliant with all local, regional, and national regulatory requirements, codes and controls.
  19. 100% Compliance on Monthly Safety Procedures Training.
  20. Ensures compliance with all company policies and practices in areas such as safety and all regulatory compliance.
  21. Role model and promote the organisations Values and Behaviours.
  22. Supports all company quality programs and initiatives.
  23. Timeliness in addressing Quality System Requirements.
  24. Principles of data integrity must be strictly adhered to.
  25. All activities to be performed in strict accordance with the Quality Management System.
  26. Constantly seeks to improve work processes; Has a quality-first mentality; Learns from internal and external best practices to apply to her/his work.
  27. Supports all company Lean Manufacturing principles.
  28. Role models and promotes the organizations Values & Behaviours.
  29. Comply with all corporate safety, environmental and quality policies.
  30. Must take personal accountability for own safety whilst supporting a culture of safety management through compliance with all safety policies, safety observation reporting, and proactive involvement in Jabil programs.
  31. Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department / position.
Job Specifications
  1. Engineering Degree and/or Master's in Mechanical or Biomedical Engineering or equivalent.
  2. Minimum 6-9 years design engineering experience in medical device design from initial concept generation, feasibility through to transfer to manufacturing.
  3. Understands root cause analysis, engineering theories, design principles, evaluation techniques and documentation control. Knowledge of materials and manufacturing techniques.
  4. Strong analytical reasoning with an ability to influence key decisions based on technical judgement.
  5. Knowledge of statistical techniques and DOE. Design for Lean Sigma and Design for Manufacture/Assembly highly desirable.
  6. Demonstrated leadership ability with clear ownership of all deliverables and responsibilities.
  7. Strong communication skills with an ability to successfully manage cross functional teams.
  8. Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDR and FDA CFR 820). Knowledge of Stage-Gate process and/or Product Development life cycle.
  9. Attention to detail and Quality focus. Proven documentation writing skills; clear and concise using objective evidence and language.
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