Mechanical Engineer

Katalyst CRO; Dublin (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO, based in Dublin, CA, is seeking a seasoned Mechanical Engineer to lead mechanical design for electromechanical medical devices. The role requires substantial experience in medical device new product development.

The ideal candidate will have over eight years of mechanical design experience, a Bachelor's or Master's in Mechanical Engineering, and proficiency with CAD tools like SolidWorks or Creo. The position includes responsibilities such as managing design activities from concept to production, ensuring compliance with relevant standards, and collaboration with cross-functional teams.

Qualifications

• 8+ years of experience in mechanical design and development for medical devices.
• Proven experience leading product lifecycle in regulated environments.

Responsibilities

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own mechanical architecture and interfaces for electromechanical subsystems.
• Lead mechanical design activities from concept to production release.
• Translate user needs into robust mechanical designs.

Skills

Mechanical design experience

CAD tools (SolidWorks, Creo)

Electromechanical integration

GD&T expertise

Manufacturing processes

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Creo

Job description

Responsibilities

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own the mechanical architecture and interfaces for electromechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
• Lead end‑to‑end mechanical design activities from concept, feasibility, and prototyping to design freeze and production release.
• Translate user needs, system requirements, and electrical/software constraints into robust mechanical designs.
• Develop and review 3D CAD models, detailed drawings, GD&T, and BOMs.
• Ensure proper integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.
• Execute development activities in compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.
• Ensure completeness and quality of Design History File (DHF) documentation.
• Lead and participate in risk management activities (dFMEA, pFMEA, hazard analysis) with cross‑functional teams.
• Support design changes through formal ECO/ECN processes.
• Define mechanical verification strategies and support DVT, EVT, and V&V testing.
• Investigate and resolve failures observed during testing, manufacturing, or field feedback.
• Lead application of DFM/DFA principles for manufacturing processes.
• Work closely with suppliers and contract manufacturers on tooling, materials, processes, and yield improvement.
• Support FAI, PPAP, pilot builds, and design transfer to manufacturing.
• Drive resolution of manufacturing issues, NCRs, and deviations related to mechanical design.
• Collaborate with electronics, software, systems, quality, regulatory, and supply chain teams.
• Lead and participate in design reviews, technical discussions, and customer walkthroughs.
• Guide and perform engineering analyses including tolerance stackups (hand calculations and FEA).
• Provide technical input for cost reduction, design optimization, and next‑generation improvements.
• Mentor and technically guide junior and midlevel engineers.

Requirements

• 8+ years of experience in mechanical design and development, with significant experience in medical device NPD.
• Proven experience leading mechanical development of electromechanical products through the full product lifecycle in regulated environments.
• Bachelor's or Master's degree in Mechanical Engineering.

Required Technical Skills

• Strong proficiency in CAD tools such as SolidWorks or Creo.
• In‑depth knowledge of materials and manufacturing processes for medical devices.
• Strong understanding of electromechanical integration, thermal considerations, EMI/EMC‑aware mechanical design, and reliability.
• Expertise in GD&T (ASME Y14.5), tolerance stackup, and DFM/DFA.
• Knowledge of FEA and practical engineering calculations.