Sr R&D Engineer

Purpose of Position
Responsible for design and reliability improvements to existing products, development of new products, processes and technologies based on company's core technology, to meet market needs and corporate objectives. Contributes to new concepts/technology in the area Gastroenterology protection.

Job Description

• Research, evaluate and test materials, assembly, and manufacturing processes to design and develop reliable and cost-effective products. Identifies appropriate design inputs defining product performance and reliability requirements.
• Develop design concepts that address product performance and reliability requirements through research, experiments, and internal and external design input.
• Support the product development effort for new product concepts. Direct internal and external resources to design and test product concepts.
• Use experimental design techniques to develop robust designs and manufacturing processes.
• Develop detailed procedures for new processes and work; prepare appropriate specifications for materials, components and product testing.
• Perform design verification and validation testing in conjunction with internal and external resources.
• Support contract manufactures, component suppliers and project teams in the design, development, optimization, validation and transfer of products to manufacturing.
• Collaborate with Quality to review and analyze complaints, conduct root cause failure mode analysis and maintain Risk Management documentation related to the product design.
• Maintain detailed documentation throughout all phases of research and development. Prepares comprehensive development reports detailing procedures, test methods, results and conclusions of all work.

  Responsibilities

• Generate design concepts and produce prototypes for evaluation.
• Develop clinically relevant bench-top tests and pre-clinical tests.
• Develop tooling and processes for manufacturing and product qualification.
• Support outsourced vendor relationships for labor-intensive components and assemblies.
• Support pre-clinical and regulatory strategy to facilitate product development and launch.
• Support procedures with clinical advisors.
• Develop products with adherence to quality systems and internal design control requirements.
• Support Intellectual Property portfolio development in conjunction with internal and external resources.
• Assist in managing timelines and allocating internal and external resources to achieve milestones and deliverables.
• Support external resources to accelerate product development.
• Assist in obtaining and assessing clinical feedback and translating into design input and product specification.
• Communicate project status to Senior Management.

Position Requirements
Minimum: B.A./B.S. in mechanical, materials, biomedical engineering or equivalent with 3-6 years of experience. SolidWorks proficiency.
Additional comments: Working knowledge of principles, concepts, and techniques in a specialty field plus general knowledge of related disciplines. Keeps abreast of current practices in the field. Works efficiently with other departments and outside professional contacts.