OrthoAccel® Technologies, Inc. is a privately owned medical device company engaged in the creation, manufacturing, marketing and sales of innovative solutions that enhance dental care and orthodontic treatment. Among the company’s innovations is AcceleDent, an FDA-cleared, Class II medical device that speeds up orthodontic treatment by as much as 50 percent. OrthoAccel, the LEADER IN ACCELERATED ORTHODONTICSTM, has received positive feedback from patients and leading orthodontists from around the world who recommend the award-winning AcceleDent as the fast, safe and gentle solution to accelerate orthodontic treatment. Ranked on Deloitte’s Technology Fast 500 as one of the fastest growing companies in North America, OrthoAccel is based in Houston, Texas and operates globally in over 40. To learn more about OrthoAccel’s focus on improving the journey to healthy, beautiful smiles, visit AcceleDent.com.
The Electronics Engineer position will serve in the Engineering and Operations department. The position will support existing product sustaining, manufacturing and production operations, new product development, and troubleshooting potential technical issues that might impact the quality of OrthoAccel products. In addition this role will drive Closed Loop Corrective Action on any issues found up to & including design changes for hardware and/or firmware.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Contribute to product development and manufacturing process of OrthoAccel products. Conduct cross functional design reviews for sustaining product changes, design transfer meetings, and design change documentation per design and document control procedures. Diagnose and troubleshoot technical issues in mechanical, electrical, firmware or software of the current in-production product and manufacturing equipment. Diagnoses shall be driven to root cause and furnished with recommendations and implementations for revision to product designs, specifications, manufacturing procedures, test procedures, quality processes and documentation. Ensure all tasks comply with 21CFR820, (FDA Quality Systems Regulations), 21CFR801 (FDA Labeling Requirements) and other applicable Federal and International standards.
MINIMUM REQUIREMENTS AND QUALIFICATIONS
- BS in EE, CS, or related discipline.
- 2- 5 years’ work experience (may include internships) with electronic or electro-mechanical products.
- Experience with programming languages: C/C++, Java or Python.
- Excellent reasoning and problem solving skills.
- Effective organization, prioritization and communication skills.
- Proficient in Microsoft Office: Word, Excel, Visio, Outlook.
- Completes projects in a timely manner.
- Team player with a results-oriented and self-starter attitude.
- Proficient in at least one CAD system for developing PCBs, PCB Assemblies, schematic capture, BOM management, and their assemblies.
- Familiarity with common laboratory test and measurement equipment such as oscilloscopes.
- Experience with embedded mixed-signal applications incorporating at least some of the following: microprocessors, DC-converting power supplies, RF communications, analog sub-systems, motors, human interfaces (LEDs, buttons, etc.), serial buses (SPI, I2C, etc.), and controlled impedances.
DESIRED SKILLS AND QUALIFICATIONS
- Experience with programming languages: C#, Java, or Python.
- Experience developing electrical assemblies in Cadence OrCAD.
- Bug tracking and bug fix experience on software.
- Proficient in understanding, trending and identifying process data to track and identify the need for corrective actions and effectivity of implemented corrective actions.
- Rechargeable Battery Chemistry (e.g. Li-Ion, NiMH, etc.) experience.
- DC Motors or other electromechanical actuators and drives.
- Experience or working design knowledge of microwave RF communications such as Wi-Fi or Bluetooth.
- Experience or working design knowledge of methods of wireless charging of devices.
- Simulation experience using Spice/LTSpice or MATLAB.
- Experience working in FDA regulated or medical device industry with knowledge of applicable standards such as IEC 60601, IEC 62304, IEC 62366, ISO 14971.
- Familiarity with lab or equipment automation languages and tools such as LabVIEW or National Instruments.
- Understanding of Quality Management System and CAPA System.
- Mobile / Portable Consumer electronics experience.
Typically 10% or less over the year.
Competitive salary, bonus eligibility comprehensive insurance benefits package, 401K and participation in OrthoAccel’s SOIP (Stock Option Incentive Plan). Compensation package will be commensurate with qualifications, expertise, and experience.
For more information: email@example.com