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.
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 fu...
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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