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
- Lead the design, development, and verification of complex assemblies, sub-assemblies, components, and packaging
- Translate user and product requirements into detailed technical specifications and design outputs
- Select materials, manufacturing processes, tooling, automation, and equipment aligned with performance and scalability needs
- Conduct feasibility assessments, engineering analyses, and proof-of-concept testing
- Drive continuous improvement initiatives focused on quality, performance, robustness, and cost
- Lead product and process risk assessments including PHA, FTA, dFMEA, and uFMEA
- Perform root cause analysis and define corrective and preventive actions
- Partner with manufacturing teams to resolve technical issues and optimise process capability
- Manage projects and sub-projects using structured project management methodologies
- Provide technical leadership to cross-functional teams and external suppliers
- Lead technical design reviews, presentations, and decision-making forums
- Oversee recruitment, performance management, and development of direct reports
- Coordinate and prioritise daily team activities to meet programme timelines
- Stay current with emerging technologies, tools, and engineering best practices
Requirements
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or equivalent
- 6–9 years’ experience in medical device design engineering, including 5+ years in a leadership role
- Experience designing both capital equipment and disposable medical devices
- Strong grounding in mechanical engineering principles and failure investigation techniques
- Advanced application of GD&T for design and inspection
- Experience with Design for Six Sigma, statistical analysis, and DOE
- Strong understanding of materials, manufacturing processes, and DFM/DFA
- Proven technical leadership with ownership of deliverables and outcomes
- Excellent analytical, problem-solving, and communication skills
- Working knowledge of ISO 13485, MDR, FDA CFR 820, and regulated design controls
- Experience with Stage-Gate or Product Development Lifecycle processes
- High attention to detail and strong documentation discipline
Benefits
- Comprehensive healthcare coverage, including options for family members
- Competitive pension scheme with employer contribution
- Performance-related incentive bonus
- Opportunity to participate in a company share investment or savings programme
- Life assurance cover
- Generous annual leave entitlement plus public holidays
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