The Principal Electrical Engineer will technically lead engineering teams through innovative design, development and deployment of the company’s medical device products that meet customer specifications and quality standards. Responsible for ensuring alignment of product development strategy to business strategy in order to accelerate the development and commercialization of products to the market. Promote and drive innovation and excellence through cross-functional collaboration and decision making while representing product development engineering interests.

Company Profile

Client is a small to mid-sized medical device company focused on interventional and diagnostic technology.

Primary Duties & Responsibilities:

• Apply solid electrical design skills to develop medical devices to meet specific performance requirements and deliver on goals according to product development quality system. This includes the full life cycle from requirements to market release.
• As a team member, be responsible for the completion of various project activities, from definition, identifying electrical functional requirements, component selection, schematic design, PCB layout, DVT, and production functional test development for PCBAs.
• Create and implement the electrical test plans/protocols and generate test reports to ensure designs meet the specifications and quality system requirements.
• Work closely with cross-function team, including design reviews with QA, RA, test engineers,
  software engineers to ensure the hardware designs meet the product requirements, including safety, reliability and serviceability.
• Provide thought leadership to the team by being creative and innovative in the product development process.
• Make, recommend, or justify critical technical decisions in product design. The decision should be based on broad investigation and testing.
• Document and transfer developed solutions to manufacturing team for mass production and
  provide technical support and sustaining development in launch phase.

Qualifications (Knowledge, Skills & Abilities):

Minimum:

• B.S. or M.S (Preferred) in Electrical Engineering
• Minimum of 5 years of experience in a similar role (prefer federally regulated hardware development)
• 10+ years of electrical engineering design
• 5+ years of new product development
• Solid history and reputation as an influencer and problem solver
• 2-3 years providing technical leadership and mentorship
• Medical device development experience and IEC60601-1, IEC62304 and related IEC standard familiarity preferred.
• An understanding of requirements for, and experience in medical device development.
• Excellent documentation skills (highly regulated development environment).
• Experience designing power supply, embedded microcontroller, and microprocessor-based systems.
• Experience designing interfaces for Ethernet, USB, Wireless (WiFi, BLE)
• Experience bringing products/systems through agency certifications: UL, FDA, CE covering safety, EMI/EMC, and medical aspects
• Analog power electronics design for servo-amplifiers and small power supplies.
• Motion control and interface circuit design.
• Experience designing FPGA interfaces using Verilog.
• Hardware development through full product life-cycle.
• Experience developing hardware design specifications, schematics, and PCB layout of multilayer high-speed assemblies.
• Demonstrated negotiating skills in a collaborative, team environment
• Documented history of high-performance results in previous positions.

Preferred:

• 4+ years of experience leading and mentoring others in a similar capacity, and/or demonstrated experience working cross-functionally in the engineering / test environment.
• Extensive experience with Altium Schematic Entry and PCB Layout tools.