OrthoAccel Technologies, Inc. (OA), founded in 2007 and located in Houston, TX, is a venture‐backed medical device company. It is engaged in the development and commercialization of a product‐line of dental appliances. Its technology accelerates bone‐remodeling to reduce the duration required to complete orthodontic treatment.
The Electrical Engineer position will serve in the Sustaining Quality department. The Electrical Engineer is an entry‐level to junior‐career position & will be responsible for production and field support of technical & quality issues on OrthoAccel
products, including driving Closed Loop Corrective Action on any issues found up to & including design changes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Act as technical expert on product hardware and software, provide diagnosis & troubleshooting backup to technician staff, drive issues to root cause, recommend &/or implement new designs to correct issues including specifications, manufacturing procedures, test procedures, quality processes and/or documentation changes to eliminate issue recurrence. Conduct cross functional design reviews for sustaining product changes, design transfer meetings, and design change documentation per design and document control requirements. Ensure or train technical competency of technician & customer support staff as appropriate, drive factory and field failures below 0.5% annually through effective development of quality plans, quality & reliability tests, manufacturing procedures, and new product technical specifications. Ensure all tasks comply with 21CFR820, (FDA Quality Systems Regulations, 21CFR801 (FDA Labeling Requirements) and other applicable Federal and International standards. It is expected this position would also contribute to the new product design effort as available.
MINIMUM REQUIREMENTS AND QUALIFICATIONS
- BSEE or BSCS plus internship(s) or work experience with electronic or electro‐mechanical products
- Hands‐on debug & diagnostic experience on electrical or electronic products
- Experience programming in C
- Electrical Analysis skills
- Good reasoning and problem solving skills
- Analog & Digital circuit experience
- Ability to review product design/engineering documents in support of design changes
- Must be self‐motivated and a self‐starter
- Effective organization, prioritization, interpersonal skills
- Excellent verbal and written skills
- Understands and uses continuous improvement tools
- Proficient in Microsoft Office and should be able to navigate 3‐D modeling software such as Solidworks
- Completes projects in a timely manner
- Ability to work in a team based environment
- Proficient in understanding, trending and identifying process data to track and identify the need for corrective actions and effectiveness of implemented corrective actions
DESIRED SKILLS AND QUALIFICATIONS
- Quality Systems Experience
- FPGA &/or μP programming experience
- Li‐Ion battery experience
- Mobile / Portable Consumer electronics experience
- Firmware programming experience
- Understands design and manufacturing guidelines for PCBA manufacturing
- Experience with IEC, ISO, ASTM, AAMI standards
- Medical Device experience
- Understanding CAPA System
Low travel requirement – typically 15% or less over the year.
Commensurate with Experience.
Please submit resume and cover letter to firstname.lastname@example.org