Sr R&D Engineer

Responsibilities

• Ensures all Design Controls aspects.
• Develops new requirements, sources new requirements, creates and validates new test methods, creates new risk documentation, and performs all applicable testing.
• Supports manufacturing moves from one vendor to another.
• Maintains product safety, quality, and compliance of all products.
• Trains in all aspects of change management (DCA, SCIA, SCAR, and PLCP).
• Supports any applicable R&D projects planning and activities.
• Understands and complies with all the regulations governing the quality system.
• Supports additional activities required by the business.
• Designs and develops new tools and fixturing using Solidworks for use in test method development and validation.

Requirements

• Bachelor's Degree in Engineering.
• 4+ years working with design controls.
• 4+ years working within FDA Quality System Regulations and ISO 13485.
• Experience with assessing quality and compliance impact on products for design and process changes.
• Experience with design verification and validations activities.
• Experience with Test Method development.
• Experience in troubleshooting and root cause analysis.
• Working knowledge of Minitab and SolidWorks.

Preferred Qualifications

• Has led projects to drive product design changes or process changes preferred.
• Mechanical design experience.
• Has participated in new product development projects, related product transfer and scale-up activities preferred.
• SAP and Windchill experience is a plus.
• Human Factors / Usability experience is a plus.