We are seeking a Lead Mechanical Design Engineer to drive the design, development and verification of complex medical devices across both capital equipment and disposable components. This is a hands?on technical leadership role where you will guide cross?functional teams, oversee full lifecycle engineering, and deliver innovative, manufacturable and compliant solutions within a regulated environment.
What You’ll Do
Lead the end?to?end design, development and verification of complex assemblies, sub?assemblies, components and packaging.
Select materials, manufacturing processes, tooling and automation solutions to meet performance, cost and scalability needs.
Translate product requirements into detailed engineering specifications and conduct feasibility studies and proof?of?concept testing.
Drive design and process optimisation to improve quality, performance and manufacturability.
Lead risk?management activities including PHA, FTA and dFMEA/uFMEA.
Perform root?cause analysis and implement corrective actions following failure investigations.
Collaborate with manufacturing teams to troubleshoot issues and refine process parameters.
Manage projects or sub?projects, guide cross?functional teams and apply structured project?management methodologies.
Support supplier and subcontractor activities and lead technical reviews with internal and external stakeholders.
Provide team leadership including recruitment, performance oversight and daily activity coordination.
Stay current with emerging engineering tools, technologies and methods to elevate team capability.
What You Bring
5+ years’ experience in medical?device mechanical design, ideally spanning capital equipment and disposable components.
Full product?lifecycle experience: design, development, verification and optimisation.
Strong background in material selection, manufacturing processes, GD&T, DFM/DFA, DOE and root?cause analysis.
Proven experience running risk?management activities (PHA, FTA, dFMEA/uFMEA).
Demonstrated project and team leadership, with clear ownership of deliverables and cross?functional coordination.
Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering or equivalent.
Deep understanding of design for manufacturability/assembly and modern engineering practices.
Strong communication skills and ability to influence decisions through technical insight.
Familiarity with medical?device regulatory frameworks (ISO 13485, MDR, FDA 21 CFR 820).
#J-18808-Ljbffr