Title: R&D Engineer

Location: Danvers, MA Onsite / Minneapolis, MN Onsite

JD:

Design and develop test methods to support additional studies.

Apply engineering principles to product design analysis and assessment.

Produce engineering reports to provide technical explanation to support domestic and international regulatory submissions.

Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device failures.

Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, etc.

Coordinate and lead competitive testing and aging testing.

Interact with physicians to assist with product demonstrations.

Optimize and refine existing products.

Develop familiarity with endovascular procedures and apply the knowledge to product development and product risk assessment.

Provide guidance to technicians and pilot associates.

Identify problems and recommend solutions.

Qualification/YOE :

Experience in leading process improvement methodologies (e.g., Lean, six sigma).

Good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements

Master’s degree in science, engineering, or a related field.