Job Description
Job Summary :
This position is responsible for supporting the development of new products, product improvements and line extensions of existing products. This includes but is not limited to : CAD design of components and systems, support of design documentation, engineering testing / analysis for new and existing products, and support of ongoing production, marketing, quality assurance and regulatory affairs activities.
Essential Job Duties and Responsibilities :
- Design parts and / or systems using 3D CAD software
- Responsibility for risk management for products and processes
- Contribute to the development of user needs and design inputs
- Research, analyze, and create intellectual property
- Provide engineering support for regulatory submissions
- Provide engineering support for production and quality assurance
- Design, document, approve, and conduct testing related to new product development and testing required in support of existing products
- Creation and review of change orders for documents related to engineering (drawings, procedures, etc.)
- Provide materials and support for clinical studies
- Suggest and implement internal process improvements
- Create graphics as needed for documentation.
- Some project management including :
Coordination of core team activities
Responsibility for following design control processes
Create and maintain the design history file during new product development
Management of project timelines
Responsibility for overall project success
Supervise and mentor lower level Design Engineers and R&D staff
Education, Experience, Skills, & Abilities :
Engineering degree with a minimum of 4 years of relevant experienceProven ability to effectively lead product development team membersProven success in leading cross functional teams to develop and commercialize new productsProven ability to drive projects and motivate team membersDemonstrated ability to design complex mechanical devicesStrong written and verbal communication skills requiredStrong organization skills, attention to detail, precision, and accuracy requiredStrong mathematical skills with a working knowledge of statistics and statistical analysis required Previous experience with engineering design and testing requiredPrevious cGMP / ISO experience in the medical device industry desiredPrevious experience in designing / maintaining cGMP / ISO-compliant Quality Systems desiredWorking knowledge of Microsoft Office software including Microsoft Project desiredSolidworks 3D CAD experience desiredExperience with manufacturing processes including plastic injection molding, metal part fabrication, and coating processes desiredFamiliar with the use of a variety of inspection measurement equipment desired