Head of Research & Development

Location

Burlington, MA | United States

Job description

Job Description

Position: Head of Research & Development

The Head of Research and Development has a deep understanding of electrophysiology and regulated medical device development. Expertise in catheter design and development is required along with a broad understanding of systems and electrical engineering. This leadership position requires close enterprise-wide collaboration. This role is based full time in our Burlington, MA office.

RESPONSIBILITIES

• Implement the Company’s development strategy
• Drive technical innovation in the design and development of products and processes
• Lead the engineering teams in the design and development process including catheter, softwarem hardware, and electrical systems
• Establish and foster strong collaborative relationships with internal and external design, development, and manufacturing partners
• Ensure design capability by means of comprehensive technical reviews, testing, and robust documentation
• Lead pre-clinical study planning and execution
• Oversee and understand project risks ensuring mitigation and contingency plans are established and activated as required
• Drive the development of statistically sound protocols and reports, design trace matrices, and risk management to support verification and validation activities
• Comply with regulatory statues and international standards for the design and development of medical products including US FDA 21 CFR Part 820 Quality System Requirements and ISO 13485 Quality Management Systems for Medical Devices
• Support regulatory submissions
• Work with the leadership team to identify and protect the Company’s intellectual property

SKILLS AND EXPERIENCE

• B.S. in Engineering (Mechanical, Biomedical, Electrical, or similar discipline) with 10+ years of experience is required
• Advanced Engineering degree is preferred
• Knowledge of cardiac EP system and all aspects of catheter development are required
• Deep technical and management leadership skills are required
• Strong problem-solving, communications, and risk assessment skills are required
• Proficiency with the creation and critical review of engineering drawings and specification documentation is required
• Ability to reject setbacks and lead teams to achieve milestones is required
• Proven ability to adapt to and rapidly learn new product and clinical domains is required
• Experience directly interacting with clinicians as customers, scientists, and during invasive procedures is required
• Experience implementing sensors and interface electronics is preferred
• Experience with FDA Design Controls and Engineering Change Management procedures for medical device development is required

Job tags

Salary