Overview
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
Qualifications
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 *****, 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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