Head of Research - Burlington, United States - Gilder Search Group

Gilder Search Group Burlington, United States

1 month ago

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Description

Precision Life Sciences - 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
Head of Research & Development

Precision Life Sciences - 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

Posted On:
Monday, May 13, 2024

Compensation:

265,000

Tagged:
ISO 13485

Medical Devices

R&D

CFR Part 820

Are you legally eligible to work in the United States without sponsorship?

Are you within reasonable commuting distance to this position? (Choose 'Yes' if position is 100% remote.)

Please describe the number of years experience you have for the requirements of this position.
This is a contract role. Are you open to working long term contract roles?

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