Leo Cancer Care: Mechanical Engineering Lead

Position Title:

Mechanical Engineering Lead

Reports to:

Mechanical Engineering Manager

Position Summary:

As a Lead Engineer in the Mechanical Engineering team, you will create and develop innovative and robust mechanical designs and leverage your experience to solve complex engineering problems. You will regularly manage interdisciplinary work packages, coordinating with adjacent teams such as electronic, systems and software engineering. Typical job duties will include creation of 3D and 2D manufacturing data packs, Bills of Materials, and supporting documentation driven by product and system level requirements.

You will mentor and support team members in the development of project deliverables, the adherence to or refinement of team processes, and in completing tasks in accordance with the QMS. As a senior member of the design team you will influence cross-functional decisions with quality, regulatory, operations and clinical specialists to turn system and product needs into designs that are safe, compliant, manufacturable and serviceable.

This is hands‑on engineering in a regulated environment: your documents and designs form part of the technical file for equipment used in the treatment of cancer.

Relevant Knowledge and Skill requirements

Required

• Bachelor's degree in mechanical engineering or a related field; master's degree is a plus
• 12+ years' experience in engineering, preferably in the medical device or other regulated industry
• 3+ years' experience as a technical lead or project lead in an engineering role
• Significant 3D CAD design experience, preferably with Solid Works
• Significant experience of technical drawing creation and maintenance
• Strong knowledge of materials, manufacturing processes, and GD&T (Geometric Dimensioning and Tolerancing)
• Works within a design control system: design inputs and outputs, traceability, formal design review, and change control via ECR/ECO.
• Experience with FEA software (e.g., ANSYS, Abaqus) and mechanical simulation tools
• Effective time management, to include coordinating / leading small teams to deliver project deliverables and guiding team members to develop these skills
• Ability to work collaboratively in a fast-paced, cross-functional team environment.
• An analytical approach to problem solving and confidence in performing mechanical calculations
• Applies design for test, manufacture and serviceability as a design input.
• Works effectively with suppliers, contract manufacturers and external test houses.
• Explains technical reasoning and risk clearly to engineers, project managers and non-specialists.
• Strong written and verbal communication skills
• Availability to travel domestically and internationally when necessary

Desirable

• Effective knowledge of the medical regulatory environment in which the business operates
• Experience in the development of Medical devices and medical device usability development needs
• Use of Quality Management tools such as DOORS, JIRA and Confluence.
• Experience working within a Systems Engineering lifecycle.

Key responsibilities:

To create high quality technical solutions working within the project requirements. Contribute to the creation and adoption of new methods and designs. Work within a small team environment enabling knowledge sharing to improve all round competence of the team. Manage your own time to provide engineering deliverables that meet with the required specifications.

Creation and management of 3D CAD data in accordance with the defined requirements. Creation and management of 2D manufacturing drawings for prototype and production. Inspection, verification and testing of manufactured components and sub-assemblies.

Perform Engineering Calculations to verify designs, including force calculations and Finite Element Analysis where required

Manage external suppliers and design resources when required. The production and review of engineering reports, specifications and design documents in accordance with Leo Cancer Care's operating procedures and international standards. The presentation and demonstration of solutions to internal/external stakeholders.

Attend and participate in regular departmental and project meetings. Attend and participate in technical reviews (both internal and external).

Support the Mechanical Engineering Manager by providing additional technical and project leadership to guide members of the mechanical engineering team in completing their assigned tasks, to include providing technical mentorship, support in technical scope management in support of…