Job Description

ESSENTIAL DUTIES

• Design, develop, prototype, and test all aspects of electrical components, systems, and products, including the assembly and part drawings, as well as other required documentation, from design concept to manufacturing release.
• Engineering analysis, design, design assurance, and sustaining responsibilities for medical device electronic hardware, principally in the area of analog, digital, embedded controls, interfacing, and power systems integration of Class II and III active medical devices
• Develop concepts for next-generation medical devices, and demonstrate these concepts through prototype design, laboratory testing, and pre-clinical tests.
• Lead the identification and execution of medical device engineering projects, including the planning (task, schedule, and budget), execution, and reporting of the associated activities and milestones.
• Perform or lead bench testing, design verification, and validation activities, including associated documentation and records of new medical devices and expansion of existing products.
• Participate in all aspects of medical device product design, including specifications development, architecture design, schematic capture and layout, hardware selection processes, PCB assembly, risk analysis, test method development, and design reviews as project leader, participant, and independent reviewer, as applicable.
• Develop, evaluate, and/or select new design methodologies and technologies that drive the development of a new generation of medical devices as well as support current ones.
• Develop engineering changes and engineering drawings with minimal design requirements and instructions.
• Create document packages that specify the complete design intent of a product, including drawings, Bill of Materials, and Engineering Change Orders.
• Interface with program management; provide oral and written high-quality status updates and meet commitments
• Serve as client liaison and/or team leader to provide support and direction to an assigned team, including facilitating team and client communications, as well as project budget adherence, including planned corrective actions as needed.
• Manage and support improvement activities in accordance with established programs and objectives as outlined in the Quality Management System.
• Responsible for the performance appraisal, development, and training of engineers

OTHER DUTIES AND RESPONSIBILITIES

• Assist with business development activities, such as defining project scope, timeline, and budget for proposals and quotes. Review project budgets for accuracy and sensibility.
• Maintain and expand job knowledge by staying current with state-of-the-art research in the field, participating in educational opportunities, reading professional publications, maintaining personal networks, and engaging with professional organizations.

MINIMUM EDUCATION, SKILLS, AND EXPERIENCE REQUIRED

• BS in Electrical Engineering (MS preferred).
• Minimum of 8 years of professional, scientific, and/or biotechnology project management experience with mandatory experience in device development. Experience with device approval process preferred (e.g., 510K application, De Novo application).
• Strong computer skills, including the MS Office suite and MS Project.
• Proven track record of system engineering on complex hardware systems. Demonstrated ability to interpret technical drawings, blueprints, specifications, illustrations, and written documents.
• Experience designing and building low-power miniaturized analog and digital systems.
• Experience managing noise and maintaining signal integrity.
• Prior experience integrating Bluetooth, Bluetooth LE, WiFi, and NFC for data communication.
• Expert at schematic capture, layout (Altium Designer preferred), and Design for Assembly/Manufacturing.
• Experience designing PCB assembly test fixtures, test methods, and design verification plans.
• Experience with programming languages such as C, MATLAB, and LabVIEW
• Demonstrated experience as a self-starter and a fast learner; must work efficiently responding to changing priorities with minimal disruption, able to work independently and within a team; must have excellent problem-solving skills, analytical skills, research skills, and attention to detail.
• Must be able to consistently meet deadlines, manage projects across several collaborators, and handle multiple projects simultaneously.
• Excellent written and verbal communication skills are required, and the ability to write clear reports, proposals, and other documents, as well as efficiently discuss them with other scientists, engineers, and customers, is essential.

ADDITIONAL DESIRABLE SKILLS

• Prior experience with flex circuits preferred
• Experience working with OEMs, contract manufacturers, and contract designers
• A successful track record in implementing medical devices, leading to FDA or CE product clearance.
• Experience with biometric and physiological sensors
• Experience with medical product development under ISO 13485, ISO 14971, ISO 62304, ISO 60601, and FDA QSR
• Experience with Jira, Bitbucket, and/or Confluence

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