Title: R&D Engineer
Location: Danvers, MA (Onsite)

Job Description:

• Design and develop test methods to support additional studies.
• Apply engineering principles for product design analysis and assessment.
• Prepare engineering reports to support domestic and international regulatory submissions.
• Conduct complaint evaluations and CAPA investigations to analyze potential device failures.
• Create and maintain technical documentation, including design history files, drawings, bills of materials, test protocols, reports, and engineering change orders.
• Coordinate and lead competitive testing and aging studies.
• Collaborate with physicians for product demonstrations.
• Optimize and refine existing products for improved performance.
• Develop expertise in endovascular procedures and integrate that knowledge into product development and risk assessments.
• Provide guidance to technicians and pilot associates.
• Identify issues and recommend practical solutions.

Qualifications:

• Experience with process improvement methodologies (e.g., Lean, Hoshin, or Six Sigma).
• Strong knowledge of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806, & 820) and medical device process requirements.
• Master's degree in science, engineering, or a related field; PMP certification preferred.