Independently create and refine CAD models for product and fixture design using standard modeling tools
Conduct simulations and calculations to support design performance and heat transfer assessments
Apply DFM and tolerance analysis to ensure part fit and ergonomic product interaction
Design simple test fixtures and tooling using HFUE principles
Execute patent searches to identify conflicts and guide unique product solutions
Utilize DFMEA to identify and mitigate design risks early in development
Draft comprehensive and traceable design documentation and test rationales
Translate user needs into clear, testable design inputs using UFMEA and task analysis
Participate in formative evaluations and plan for design validation activities
Develop test methods aligned with design verification strategies
Perform design verification activities and analyze test outcomes for conformance
Prepare phase-specific development plans and maintain updated D&D documentation
Generate and manage essential design outputs, including drawings and assembly instructions
Ensure compliance with ISO and FDA design control standards during development
Provide support during design reviews to align design work with regulatory requirements

Bachelor’s degree in Mechanical, Biomedical, or related Engineering field
2–4 years of experience in medical device product development, preferably in vascular access
Candidates without a technical degree require 6+ years of equivalent industry experience in medical device development

Engineer 2, Product Development, R&D

Key skills