Manager Mechanical Engineering

• Lead product design and development from concept to validation and transfer to manufacturing, ensuring technical and process integrity.
• Provide technical leadership in developing mechanical subsystems that integrate seamlessly with optics, microfluidics, electronics, and software to deliver robust, compact diagnostic devices.
• Oversee the design of enclosures, mechanisms, thermal management solutions, and structural components optimized for medical device use.
• Guide material and process selection to ensure biocompatibility, durability, and cost- effectiveness.
• Ensure DFX principles are embedded throughout design and development to enhance manufacturability, assembly, serviceability, and scalability.
• Ensure mechanical simulations, including structural, dynamic, and tolerance analyses, are effectively planned, executed, and reviewed to verify integrity and mitigate early-stage risks.
• Lead investigation and resolution of mechanical and system-interface failures, ensuring timely root-cause analysis and corrective actions.
• Collaborate with suppliers, OEMs, and manufacturing partners to enable reliable, scalable, and timely production.
• Define and implement manufacturing enablers such as fixtures, automation, and inspection systems to ensure consistency, quality, and cost efficiency.
• Establish and maintain mechanical design standards, best practices, and reusable design frameworks.
• Lead design reviews, risk analyses, and verification plans with cross-functional teams.
• Ensure adherence to ISO 13485, ISO 14971, and related standards during design and verification.
• Supervise creation and maintenance of technical and regulatory documentation, including DHF, DMR, and risk files, ensuring audit readiness and compliance.

Key Requirements

• Bachelor s or Master s degree in Mechanical Engineering or a related field, with at least 12 years of experience in product design and development for medical or other safety-critical devices.
• Proven expertise in mechanical design of enclosures, mechanisms, and structural components, with proficiency in CAD modeling, tolerance analysis, and DFM/DFA principles.
• Experience in materials selection, mechanical simulations, and reliability testing (vibration, drop, thermal) to ensure manufacturability and durability.