We are seeking a highly skilled Lead Mechanical Design Engineer to drive the design, development, and verification of complex medical devices — including both capital equipment and disposable components. This is a senior technical role requiring strong multidisciplinary engineering capability across mechanical, mechatronic, electronic, and manufacturing engineering domains.
The ideal candidate will be responsible for translating product requirements into robust design specifications, leading feasibility studies, guiding design verification, and ensuring manufacturability and compliance with medical device standards. This role also includes cross-functional project leadership, structured risk analysis, and contributing to continuous improvement across the engineering function.
Key Responsibilities
Design & Development
* Lead the design and development of complex assemblies, sub‑assemblies, and components for medical devices.
* Select materials, manufacturing processes, tooling, and equipment to meet performance and regulatory needs.
* Translate product and user requirements into detailed engineering specifications.
* Conduct feasibility studies, proof‑of‑concept work, and engineering evaluations.
* Drive product and process improvements to enhance performance, quality, and cost‑efficiency.
Verification & Risk Management
* Lead design verification activities, ensuring compliance with engineering standards and regulatory expectations.
* Conduct structured risk assessments, including PHA, FTA, and FMEA (dFMEA/uFMEA).
* Perform root‑cause analysis and implement corrective/preventive actions for failures or non‑conformances.
Cross‑Functional Collaboration
* Work closely with manufacturing engineering to resolve build issues and optimize processes.
* Provide technical support and guidance to suppliers and subcontract manufacturers.
* Partner with teams across quality, regulatory affairs, electronics, systems, and operations.
* Lead technical design reviews and present conclusions to internal and external stakeholders.
Project Leadership
* Manage projects or sub‑projects, define work packages, assign tasks, and ensure timely execution.
* Apply structured project management methodologies.
* Coordinate daily activities for the engineering team and support recruitment, onboarding, and development of team members.
* Stay up to date with emerging technologies, tools, and engineering best practices.
About You
Education & Experience
* Bachelors or Masters degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
* 6–9 years experience in medical device design engineering, including at least five years leading mechanical design teams or projects.
* Proven track record developing both capital equipment and disposable medical device components.
Technical Skills
* Strong understanding of mechanical engineering principles, manufacturing processes, and design for manufacturability/assembly (DFM/DFA).
* Proficiency in GD&T and application in design and inspection.
* Experience with Design for Six Sigma (DFSS), statistical analysis, and DOE methodologies.
* Expertise with risk analysis tools (PHA, FTA, FMEA).
* Deep knowledge of root‑cause investigation and CAPA processes.
* Familiarity with regulated product development environments and quality systems, ideally EN ISO 13485, MDR, and FDA 21 CFR 820.
* Understanding of Stage‑Gate or Product Development Life Cycle methodologies.
Soft Skills
* Strong leadership capability with clear ownership of deliverables.
* Excellent communication skills and ability to collaborate across functions.
* High attention to detail and a quality‑first mindset.
* Strong analytical and problem‑solving skills.