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 experience
• Proven ability to effectively lead product development team members
• Proven success in leading cross functional teams to develop and commercialize new products
• Proven ability to drive projects and motivate team members
• Demonstrated ability to design complex mechanical devices
• Strong written and verbal communication skills required
• Strong organization skills, attention to detail, precision, and accuracy required
• Strong mathematical skills with a working knowledge of statistics and statistical analysis required Previous experience with engineering design and testing required
• Previous cGMP/ISO experience in the medical device industry desired
• Previous experience in designing/maintaining cGMP/ISO-compliant Quality Systems desired
• Working knowledge of Microsoft Office software including Microsoft Project desired
• Solidworks 3D CAD experience desired
• Experience with manufacturing processes including plastic injection molding, metal part fabrication, and coating processes desired
• Familiar with the use of a variety of inspection measurement equipment desired

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