Engineer 2, Product Development, R&D

Position Summary

The Project Engineer – Design Development applies core engineering principles to develop innovative vascular access products that meet clinical needs and regulatory standards. This role supports product design through modeling, testing, and documentation, while contributing to risk reduction and usability validation. The engineer collaborates cross-functionally to ensure designs translate effectively into manufacturable and high-quality solutions.

Principal Responsibilities

•    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.

Education / Experience 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.

Specialized Skills / Other Requirements

Complementary Skills for Cross-Functional Awareness:

•    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.

Behavioral Competencies:
•    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.

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