Lead Mechanical Design Engineer

About the role

The Lead Mechanical Design Engineer plays a pivotal role in the design, development, and verification of complex medical devices, encompassing both capital equipment and disposable components. This position demands a multidisciplinary engineering approach, integrating mechanical, mechatronic, electronic, and manufacturing expertise to deliver innovative, high-performance, and compliant solutions. The engineer will be responsible for translating product requirements into detailed specifications, selecting appropriate materials and processes, and conducting feasibility studies and proof-of-concept testing. A key focus will be on driving design and process improvements to enhance product quality, performance, and cost-efficiency, while ensuring manufacturability and scalability.

In addition to technical leadership, the role involves managing cross-functional project teams, applying structured project management methodologies, and leading risk assessments such as PHA, FTA, and FMEA. The engineer will oversee root cause analysis and corrective actions, support supplier and subcontractor collaboration, and provide technical guidance throughout the product lifecycle. This role also includes team leadership responsibilities such as recruitment, performance management, and daily coordination of activities to ensure timely execution. The successful candidate will be a strong communicator, capable of leading technical reviews and presentations across internal and external stakeholders, while staying abreast of emerging technologies and tools to continuously elevate engineering capabilities.

Main responsibilities will include:

• Lead and manage the design, development, and verification of complex assemblies, sub-assemblies, components, and packaging.
• Select appropriate materials, processes, tooling, automation, and equipment to meet design and manufacturing needs.
• Translate product requirements into comprehensive product specifications.
• Conduct engineering studies and proof-of-concept testing to evaluate design feasibility.
• Drive design and process improvements to enhance performance, quality, and cost-efficiency.
• Lead risk assessments including PHA, FTA, dFMEA/uFMEA for product and manufacturing processes.
• Perform root cause analysis and implement corrective actions based on failure investigations.
• Collaborate with manufacturing teams to troubleshoot issues and optimize process parameters.
• Manage projects or sub-projects, assigning tasks and guiding cross-functional teams.
• Apply structured project management methodologies and communicate effectively with internal and external stakeholders.
• Research and integrate emerging technologies and development tools.
• Oversee recruitment, performance management, and development of direct reports.
• Coordinate and prioritize daily team activities to ensure timely task completion.
• Provide technical support to suppliers and subcontract manufacturers.
• Lead technical reviews and presentations across internal teams and external partners.

About you

• Bachelor's or Master's degree in Mechanical or Biomedical Engineering (or equivalent).
• 6-9 years of experience in medical device design engineering, including at least 5 years leading mechanical design teams.
• Proven experience in developing both capital equipment and disposable medical device components.
• Strong foundation in engineering principles, root cause analysis, and documentation control.
• Proficient in GD&T and its application in design and inspection.
• Skilled in Design for Six Sigma (DFFS), statistical analysis, and DOE methodologies.
• Deep understanding of materials, manufacturing techniques, and design for manufacturability/assembly.
• Demonstrated leadership with clear ownership of deliverables and team outcomes.
• Strong analytical reasoning and ability to influence decisions through technical insight.
• Excellent communication skills and experience managing cross-functional teams.
• Familiarity with medical device quality and regulatory systems (EN ISO13485, MDR, FDA CFR 820).
• Knowledge of Stage-Gate or Product Development Life Cycle processes.
• High attention to detail and a quality-first mindset with proven documentation skills.