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 externalLeading 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