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.
