Job Description

Essential Duties and Responsibilities

• Develop, model, and maintain complex multi-component assemblies and detailed part drawings using SolidWorks.
• Translate engineering concepts and design inputs into accurate 3D models, 2D drawings, and specifications.
• Apply ASME Y14.5-2009 GD&T standards to ensure functional intent and manufacturability.
• Manage CAD data within SolidWorks PDM including revision control and lifecycle workflows.
• Support Engineering Change Orders (ECOs) and maintain drawing and documentation accuracy.
• Collaborate with engineering, quality, manufacturing, and regulatory teams throughout the product lifecycle.
• Ensure compliance with FDA QSR, ISO 13485, ISO 9001, and GMP requirements.
• Maintain Design History Files (DHF) and support design reviews and verification activities.
• Mentor junior designers and support CAD standards and continuous improvement initiatives.

Position Requirements

Education and Experience

• Associate degree in Engineering Technology, Mechanical Design, or related discipline with a minimum of 5 years of CAD design experience; OR
• Minimum of 10 years of CAD design experience in lieu of a post-secondary degree.
• Experience working in a regulated medical device product development environment.

Knowledge, Skills, and Abilities

• Advanced proficiency in SolidWorks (parts, assemblies, drawings, configurations).
• Experience with SolidWorks PDM or equivalent Product Data Management systems.
• Strong working knowledge of ASME Y14.5-2009 GD&T.
• Ability to design and document complex mechanical assemblies.
• Strong attention to detail and documentation accuracy.
• Effective written and verbal communication skills.
• Ability to manage multiple priorities and meet deadlines.

Preferred Qualifications

• Certified SOLIDWORKS Associate (CSWA) or higher (CSWP preferred).
• Certified GD&T Specialist or equivalent training.
• Experience with New Product Introduction (NPI) activities.

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