Job Summary:
The Director, Systems & Hardware Engineering will hire, develop and lead a team of system and hardware (Electrical/Mechanical) engineers focused Class 3 medical devices. As a functional leader, the Director will lead and own delivery of all deliverables associated with Systems and Hardware teams including supporting field complaint investigations, as well as product reliability and performance improvements. This is a key role, working in close collaboration with other functions and stakeholders including customers, commercial, regulatory, medical, etc.
Duties and Responsibilities include, but are not limited to:
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Develop system project plans and provide feedback on development strategy, development cost, product cost, project risks and timelines for each project
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Provide expertise on engineering systems; plan, advise, analyze, design, test and manage group which will manage highly complex engineering systems
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Develop, maintain, and apply a variety of system (patient/sensor/hardware/software) models through the use of clinically derived data
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Responsible for design and development of systems that include, electrical, mechanical and software sub-components.
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Provide broad technical leadership in area of expertise helping company set technical direction and course for future programs.
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Provide direction and recommend design options and perform experiments to determine potential design feasibility or application.
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Responsible for ensuring that design activities are coordinated per the development procedure. Establish and maintain project schedules
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Strong mentor to other engineers and technicians
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Exercises wide latitude in determining objectives and approaches to critical assignments
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Possess good personal communication skills, both written and verbal – for internal and external stakeholders
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Responsible for design/development activities which may including leading, participating, or supporting Concept, planning, design and execution stages, including:
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Risk assessment
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Prototyping
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Concept validation
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Implementation
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Verification testing
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Desk reviews
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Product validation
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Pre-production
- Participate in the all phases of development across multiple projects; investigate interchangeability, replacement, cost factors, and ease of manufacture. Coordinate with project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs applicable standards and procedures. Work with all Project team members throughout the development in order to ensure that products are produced in a safe, efficacious and quality manner while keeping within established time frames
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Own or assist in generation of technical reports including Design of Experiments (DOE), external interfaces, internal interfaces, component qualification, product testing, FMEA, statistical analysis
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Present information on projects, initiatives or other subjects to peers, teams and upper management.
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Ensure coverage of all areas of expertise necessary to support and grow the business within the functional areas of responsibility; support the current and future work demands and project deliverables.
Knowledge, Skills, Abilities, and Requirements:
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BS in Engineering (EE, CS, BME, ME)
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MS/Ph.D. in technical field preferred
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15+ years’ experience encompassing
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engineering project/program management of hardware based systems
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Experience in developing and testing electrical hardware, such as custom ASIC, stacked microchip platforms, PC board level development and proficiency in state-of-the-art electrical hardware development techniques.
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5+ years of experience in people management
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Good understanding of Class 3 product development with knowledge of documentation and process needs to meet FDA and CE regulatory requirements
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Experience in developing and testing electrical hardware, such as custom ASIC, stacked microchip platforms, PC board level development and proficiency in state-of-the-art electrical hardware development techniques
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Technical expertise and experience in one or more of the following areas: digital signal processing, electrical circuit design, sensor design, wireless technology.
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Deep understanding of all diagnostics engineering instrumentation
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Excellent written and oral communication skills
