Durham, NC 27709
Salary: $17.00 to $20.00 /hour
Baebies Inc. (www.baebies.com) is a well-funded growth-stage company that develops and commercializes products for testing in the newborn screening and pediatric diagnostic markets. The company’s existing FDA-cleared SEEKER product is sought by US public health labs, where the majority of biochemical newborn screening occurs. The company has shipped over 7 million SEEKER tests to date. Baebies second diagnostic platform, FINDER, is 510(k) pending and is poised for explosive growth in the near term.
The Instrument and Calibration Technician is responsible for assembly and installation of equipment and performing calibration, troubleshooting, repair, and validation of process instrumentation and controls. This role with also provide support for general facilities maintenance.
Duties and Responsibilities
· Assemble, install, calibrate, fix, repair, and modify instrumentation or systems for manufacturing applications as well as electronic, electromechanical, and pneumatic control devices for utility systems which support the manufacturing facilities. May include: temperature; pressure differential room pressures, chart recorders, freezers/refrigerators, HVAC
· Perform calibrations and scheduled preventive maintenance on analytical and other laboratory instruments per Metrology procedures as designated by supervisor.
· Test control systems/instruments and assist in validation of new and existing manufacturing facilities
· Follow all Process Instructions (MPI’s and TPI’s), SOP’s, Quality Policy and other related documents.
· Records applicable information on engineering work orders and travelers, ensuring material traceability, and compliance to good manufacturing practices and standard operating procedures.
· Writing validation and maintenance protocols.
· Work independently and make sound judgments regarding work methods and tools and provide support across functional areas and sites.
o Bachelor of Science degree, Assembly Technical School or related work experience
o Minimum of 2 years of experience in assembly and repair of instruments, or medical devices or other regulated systems.
o Proficient in MS Word and Excel.
o Attention to detail is critical, especially relating to assembly process and manufacturing paperwork.
o Experience with operating a computer and software, both instrument control and manufacturing systems.
o Ability to collect and record measurement data on paper forms, or electronic spreadsheets, and the ability to interpret such data.
Skills, Abilities & Characteristics
o Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation
- Ability to troubleshoot complex process systems
o Strong verbal and written communications skills.
o Vision abilities required by this job include excellent eyesight and good color vision.
o Demonstrates a sense of urgency, strong work ethics, and a “can do” attitude.
o Good interpersonal skills; ability to work as an effective team member.
o Embraces and leverages diversity of culture and thought.
o Requires a working knowledge of design control to support and assure completion of compliant design control deliverables. Requires a thorough working knowledge of FDA’s QSR (Quality System Regulations) and ISO 13485 standard.
o Experience in the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, and Root Cause Analysis required.
1st shift with ability for some work from home, with flexibility to work other shifts, as needed.
o Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level.
o Ability to stand, walk, lift, push or pull light weight occasionally 5 – 20 pounds and reach with hands and arms.
o Capable to bend, squat, stretch, and reach when performing assembly work.