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Head of Research Development

Burlington, MA, United States

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

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