Lead Mechanical Design Engineer
Summary
Lead Mechanical Design Engineer responsible for the design, development, and verification of complex medical devices including capital equipment and disposable components. This role combines deep technical leadership with project and people management to deliver compliant, manufacturable, and high-performance solutions.
Responsibilities
1. Lead the design, development, and verification of complex assemblies, sub-assemblies, components, and packaging
2. Translate user and product requirements into detailed technical specifications and design outputs
3. Select materials, manufacturing processes, tooling, automation, and equipment aligned with performance and scalability needs
4. Conduct feasibility assessments, engineering analyses, and proof-of-concept testing
5. Drive continuous improvement initiatives focused on quality, performance, robustness, and cost
6. Lead product and process risk assessments including PHA, FTA, dFMEA, and uFMEA
7. Perform root cause analysis and define corrective and preventive actions
8. Partner with manufacturing teams to resolve technical issues and optimise process capability
9. Manage projects and sub-projects using structured project management methodologies
10. Provide technical leadership to cross-functional teams and external suppliers
11. Lead technical design reviews, presentations, and decision-making forums
12. Oversee recruitment, performance management, and development of direct reports
13. Coordinate and prioritise daily team activities to meet programme timelines
14. Stay current with emerging technologies, tools, and engineering best practices
Requirements
15. Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or equivalent
16. 6–9 years' experience in medical device design engineering, including 5+ years in a leadership role
17. Experience designing both capital equipment and disposable medical devices
18. Strong grounding in mechanical engineering principles and failure investigation techniques
19. Advanced application of GD&T for design and inspection
20. Experience with Design for Six Sigma, statistical analysis, and DOE
21. Strong understanding of materials, manufacturing processes, and DFM/DFA
22. Proven technical leadership with ownership of deliverables and outcomes
23. Excellent analytical, problem-solving, and communication skills
24. Working knowledge of ISO, MDR, FDA CFR, and regulated design controls
25. Experience with Stage-Gate or Product Development Lifecycle processes
26. High attention to detail and strong documentation discipline
Benefits
27. Comprehensive healthcare coverage, including options for family members
28. Competitive pension scheme with employer contribution
29. Performance-related incentive bonus
30. Opportunity to participate in a company share investment or savings programme
31. Life assurance cover
32. Generous annual leave entitlement plus public holidays
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