Senior R&D Engineer

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Ledgent Technology, is seeking a Senior R&D Engineer to collaborate with teams on design engineering, risk management, and quality assurance, while also mentoring engineers and supporting compliance with regulatory standards.

Responsibilities:

• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance
• Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities
• Strong leadership and collaboration with other leaders in project and across the organization
• Mentor engineers in understanding of quality systems and strategies within new product development
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools
• Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures
• Train, coach, and guide lower-level employees on more complex procedures
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work

Requirements:

• Bachelor's degree in engineering required
• 5-7 Years Experience Required
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports
• Creativity, verbal and written communication skills, analytical and problem solving ability
• Team player and detail oriented
• Basic leadership and mentoring skills necessary to provide support and constructive performance feedback
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD)