Job description

The company is developing a high-resolution, real-time, 3D electroanatomical mapping system that will be used during cardiac procedures to generate novels maps of atrial fibrillation (AF) using data acquired from an ultra-high-resolution catheter. We are seeking an experienced analytical electrical engineer to join the team as Head of Systems Engineering and Technical Project Management.

This highly collaborative role requires a deep understanding of signal processing, electrical system design and medical device development. The role will be responsible for the leadership of complex product development to include software, mechanical and electrical engineering, creating a high-resolution 3D electro-anatomical mapping system. This position reports to the CEO.

Responsibilities

•Lead systems engineering activities, including driving architecture and requirements for complex systems and subsystems
•Lead all technical project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities
•Comply with regulatory statutes for the design and development of medical products per 21 CFR Part 820
•Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers
•Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs
•Participate in the design and development of mechanical, electromechanical, and disposable parts and assemblies
•Apply systems engineering techniques to effectively manage requirements, traceability and risk management
•Lead the development and execution of formal V&V testing and reports
•Establish and maintain detailed project plans, define risks and recommend contingency plans as required
•Develop tools and metrics for tracking performance of systems and components

Skills and Experience

•B.S./M.S. in Engineering (Biomedical, Electrical or similar discipline) along with 10+ years of experience, depending on degree level
•Knowledge of cardiac electrophysiology strongly preferred
•Proficient with the creation and critical review of engineering drawings and specification documentation.
•Ability to reject setbacks and enthusiastically persist until goals are achieved
•Proven ability to adapt to and rapidly learn new product and clinical domains
•Experience directly interacting with clinicians as customers, scientists, and during invasive procedures
•Well versed in the elements of intravascular catheter development including shaft design, handle design, and adhesives
•Experience implementing sensors and interface electronics
•Create strong relationships across all functions: marketing, quality, regulatory and operations
•Skilled at working with cross functional teams and achieving high performance in the face of new discoveries and challenges
•Experience with FDA Design Controls and Engineering Change Management procedures for medical device development required
•Fully vaccinated against COVID-19

Job Type: Full-time

Pay: Up to $200,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Burlington, MA: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Will you now, or in the future, require sponsorship for employment visa status (e.g., H-1B visa status)?

Experience:

• Project leadership: 2 years (Required)
• Medical device: 2 years (Preferred)
• Electrophysiology: 2 years (Required)

Work Location: In person

offroadmanagementgroup.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, offroadmanagementgroup.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, offroadmanagementgroup.com is the ideal place to find your next job.