Job Description Summary

Job Description

Responsibilities:

• * Design and develop mechanical components and assemblies for medical devices, adhering to industry standards, regulatory requirements, and internal specifications.
• * Conduct detailed engineering analysis, including stress, thermal, and kinematic analysis, using FEA and other simulation tools.
• * Create 3D CAD models, detailed drawings, and specifications using industry-standard software (e.g., SolidWorks, Creo, CATIA).
• * Participate in design reviews, providing technical expertise and feedback to ensure design integrity and manufacturability.
• * Collaborate with cross-functional teams including electrical engineers, software engineers, manufacturing, and quality assurance throughout the product development lifecycle.
• * Develop and execute test plans, analyze test data, and troubleshoot design issues to optimize product performance and reliability.
• * Identify and evaluate new materials, manufacturing processes, and technologies to improve product design and reduce costs.
• * Maintain accurate and detailed design documentation, including design history files (DHF), engineering change orders (ECOs), and technical reports.
• * Support manufacturing transfer activities and resolve production-related mechanical design challenges.

Essential Requirements:

• Strong fundamentals in mechanical engineering design and analysis
• Hands-on experience with:
  • Sheet metal, machined, fabricated components
  • Plastic parts (injection molded and thermoformed)
• Expertise in 3D CAD modeling and 2D detailing (e.g., Creo, NX, SolidWorks, CATIA)
• Proficiency in:
  • Tolerance stack-up analysis
  • FMEAs (DFMEA/PFMEA)
  • Design verification and validation
• Solid understanding of Design for Manufacturability (DFM) and Design for Assembly (DFA)
• Strong capability in mechanical BOM creation and management

2. Product Development & NPI Skills

• Experience across full product development lifecycle, including:
  • Concept and architecture development
  • Detailed design and documentation
  • Prototyping and testing
  • Manufacturing introduction and service support
• Ability to define and execute component, subsystem, and system-level verification
• Experience working with prototype vendors and production manufacturers

3. Supplier & Manufacturing Skills

• Leading DFM and drawing review discussions with suppliers
• Supplier engagement on:
  • Part design and development
  • Manufacturing processes
  • Cost optimization and packaging
• Experience in packaging design and validation
• Understanding of strategic sourcing and common technology reuse

4. Cross-Functional & Communication Skills

• Ability to work effectively with:
  • Cross-functional teams (Manufacturing, Quality, Supply Chain, Systems, Service)
  • Customers and technical leaders
• Clear communication of technical concepts to non-technical stakeholders
• Ability to “connect the dots” across technologies and platforms
• Strong documentation and presentation skills

5. Problem-Solving & Decision-Making

• Strong analytical and troubleshooting skills
• Ability to resolve moderately complex technical issues independently
• Sound engineering judgment within defined procedures and standards
• Willingness to seek guidance for issues beyond defined scope

Additional Information