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Senior Staff Engineer - Embedded Electronics

Senior Staff Engineer - Embedded Electronics

OrthofixLewisville
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SUMMARY :

Lead the development of embedded medical devices by providing technical guidance and leadership to a team of multidisciplinary engineers. Help to identify new technologies that can improve or expand the company’s product pipeline related to the use of different energies / stimulations to enhance / accelerate the body’s healing process. Therapies may include for example bone growth therapy, reduction in pain / inflammation, tendon repair, cartilage preservation, etc. Therapies may be based on the delivery of specific stimulation / energies, for example ultrasound, light, electrical stimulation, etc.

DUTIES AND RESPONSIBILITIES (essential functions of position) :

  • Responsible for the development of electronics and, on a limited basis, firmware, for use in medical devices.
  • Lead team in helping to resolve complex development issues, roadblocks, or challenges.
  • Facilitate needed cross-functional communication and problem resolution.
  • Develop or lead the development of complex product and component specifications.
  • Develop protocols for verification testing and perform or supervise verification testing.
  • Optimize or develop new processes to improve and increase innovation speed and capacity.
  • Lead the activities of, or participate on, one or more inter-disciplinary product development teams.
  • Key contributor to Risk Management activities : characterize critical hazards, develop or lead development of risk analyses (FMEAs, FTAs, Hazard Analyses, etc.)
  • Assess emerging technologies and advise management of their potential applications to improve existing products ( Bone Growth Therapy) or can lead to additional product offerings.
  • Participate in due diligence efforts in the acquisition process of new technologies.
  • Participate leading engineering, product development and integration efforts at acquired companies when necessary.
  • Specify and design test equipment and fixtures, develop testing procedures and specifications to support product and project objectives.
  • Act as technical liaison between Engineering, QA, Manufacturing and Marketing for internal as well as external efforts. The later may be necessary because of acquisitions, license agreements or outsourced projects.
  • Follow Design Control procedures under FDA and ISO regulations.
  • Lead internal / external efforts to develop and support organization’s clinical research projects.
  • Regular attendance required.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS :

  • Analog and digital electronic circuit design experience preferably in portable low power applications.
  • Schematic capture experience.
  • PCB layout experience.
  • Strong working knowledge of electronics, software, and firmware.
  • Ability to use Spectrum Analyzers, Oscilloscopes, etc.
  • Ability to prototype electronic breadboards.
  • Electrical Engineering Degree or equivalent.
  • Minimum of ten (10+) years Electronics Engineering experience.
  • NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred) :

  • Familiar with QSR and MDD / MDR as it applies to the design of Electronic Devices.
  • SUPERVISORY RESPONSIBILITIES :

  • Providing technical supervision and leadership to multidisciplinary development teams including electrical, software / firmware, and mechanical engineers focused on designing embedded medical devices. Teams may be company internal or external
  • Leading and assisting new team members with obtaining necessary tools, familiarization with Orthofix policies and processes, and providing assistance as needed to reduce ramp up time.
  • Focus, coordinate, and facilitate regular team communication. Summarize team status to management and the project team.
  • Key contributor providing input on scope, team scheduling, and project planning for new projects.
  • Participate in identifying team resource gaps, interviewing, and identification of potential new team members or resources.
  • DISCLAIMER

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    Staff Engineer • Lewisville