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Mechanical Engineer

Katalyst Healthcares and LifesciencesTampa, FL🇺🇸United StatesPosted 14 Aug 2026

Quick Overview

Work Type
Hybrid
Level
Mid Senior

Job Description

Roles & Responsibilities:

  • ct as technical lead for mechanical design within electromechanical medical device programs.
  • Own the mechanical architecture and interfaces for electro-mechanical 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 stack-ups (hand calculations and FEA).
  • Provide technical input for cost reduction, design optimization, and next-generation improvements.
  • Mentor and technically guide junior and mid-level 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 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 stack-up, and DFM/DFA.
  • Knowledge of FEA and practical engineering calculations.

Skills

CAD
FEA
GD&T
Mechanical Design
SolidWorks

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