Lead Mechanical Design Engineer

The Lead Mechanical Design Engineer is responsible for the design, development, and verification of complex medical devices, including both capital equipment and disposable components. This role requires a multidisciplinary engineering approach, combining mechanical, mechatronic, electronic, and manufacturing expertise to deliver innovative, high-performance, and regulatory-compliant solutions. Key Responsibilities

• Lead the design, development, and verification of complex assemblies, sub-assemblies, components, and packaging solutions.
• Define and select suitable materials, manufacturing processes, tooling, automation, and equipment to support product and production requirements.
• Translate product and system requirements into detailed engineering specifications.
• Conduct engineering evaluations, feasibility studies, and proof-of-concept testing to validate design concepts.
• Identify and implement design and process improvements to optimize product performance, quality, and cost.
• Lead risk management activities including PHA, FTA, and dFMEA/uFMEA for both product design and manufacturing processes.
• Perform root cause analysis on product or process failures and implement effective corrective and preventive actions.
• Partner with manufacturing teams to troubleshoot production issues and optimize process parameters.
• Manage engineering projects or workstreams, assigning tasks and guiding cross-functional teams to meet project objectives.
• Apply structured project management and product development methodologies while maintaining clear communication with stakeholders.
• Research and evaluate emerging technologies, materials, and development tools to support innovation.
• Lead recruitment, development, and performance management of team members.
• Coordinate and prioritize daily team activities to ensure timely execution of deliverables.
• Provide technical support and guidance to suppliers and subcontract manufacturing partners.
• Lead technical design reviews and present project updates to internal and external stakeholders.

Qualifications And Experience

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• 6–9 years of experience in medical device design engineering, including a minimum of 5 years in a mechanical design leadership role.
• Demonstrated experience developing both capital equipment and disposable medical device products.
• Strong knowledge of engineering fundamentals, root cause analysis techniques, and controlled documentation practices.
• Proficiency in Geometric Dimensioning and Tolerancing (GD&T) and its application in design and inspection.
• Experience with Design for Six Sigma (DFSS), statistical analysis, and Design of Experiments (DOE).
• In-depth understanding of engineering materials, manufacturing technologies, and design for manufacturability and assembly.
• Proven leadership capability with accountability for project deliverables and team performance.
• Strong analytical and problem-solving skills with the ability to influence technical decisions.
• Excellent communication skills with experience leading cross-functional teams.
• Familiarity with medical device regulatory and quality systems, including EN ISO 13485, MDR, and FDA 21 CFR Part 820.
• Knowledge of Stage-Gate or Product Development Lifecycle processes.
• Strong attention to detail with a quality-focused approach and robust documentation practices.

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