Responsible for creating and maintaining manufacturing processes for assembly of electronic medical equipment. Develops and specifies process equipment and tooling specifications. Designs fixtures and jigs using AutoCAD and/or SolidWorks. Designs programming and functional test systems for sub-assembly and final assemblies using schematic capture. Creates process automation software using LabVIEW. Performs process validations; following IQ/OQ/PQ procedures. Trains manufacturing personal on processes. Completes disposition of materials and components; works with suppliers to reduce quality issues. Develops and execute cost reduction plans and practices continuous improvement by utilizing best practices; such as lean and six sigma methodologies. Develops and modifies processing or handling equipment requirements and specifications, and reviews processing techniques for manufacture of new products and to decrease cost, improve throughput, and improve overall quality for commercial product lines. Leads design transfer and manufacturing transfer tasks for new and existing products.
Leads/participates in process development, product transfer, and process improvement projects to improve product quality, decrease cost, and improve manufacturing efficiencies.
Develops test plans, validation IQ/OQ/PQ protocols, test protocols. Execute protocols and write reports to ensure equipment/processes meet part/assembly.
Applies statistical methods to estimate future manufacturing requirements, production and field performance data to identify issues and opportunities for improvements.
Develops and maintains project timelines and provides updates and feedback to project leadership.
Supports new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields.
Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and the Packaging Department/and or Production Department to ensure cost effective new product development and introduction into manufacturing
Accomplishes tasks while conforming to the company quality system procedures.
Works with Electrical, Mechanical, and Software Engineering to create assembly process, programming process and functional test process for Medical Instruments
Designs process and test fixtures using CAD: SolidWorks, Schematic Capture, Circuit Board layout.
Creates process automation using LabVIEW or Matlab. Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
Develops and execute Process Validation Protocols, generates manufacturing assembly and in-process acceptance procedures
Supports investigation, disposition, and corrective action of non-conforming materials
Troubleshoots equipment issues, create preventive maintenance procedures for process equipment.
Bachelors’ degree in Industrial, Chemical, Bioengineering, Mechanical Engineering or science related field with 8+ years of related experience, or a Masters’ degree in Industrial, Chemical, Bioengineering, Mechanical Engineering or science related field with 5+ years of related experience.
Equipment and process Qualification (IQ, OQ, PQ) experience
Knowledge of Good Manufacturing Practices (GMP)
Calibration knowledge and understanding
Process development experience
Packaging and plastics assembly experience highly preferred
Medical Device, FDA regulated environment
Excellent technical writing abilities
Excellent conceptual, analytical, and problem-solving abilities.
Ability to be part of a team and adept in building and leading teams.
Experience with planning and executing process validations and managing process risk assessment
Good verbal and written communication skills, and the ability to effectively interface with Research and Development, Quality Assurance, and other functional groups in the organization
Compensation On par with market salary, stock compensation and a performance based incentive
Duration 3 to 6 months (but likely to be extended FTE)
Location Phoenix, Arizona
Employer Neolight is a neonatal medical device firm located at Scottsdale, Arizona. We aim to create empathy-driven solutions to newborn care and become a thought-leader in neonatal space by 2020. We started off with a phototherapy device to eradicate Kernicterus by treating Jaundice affected babies, with multiple products pipelined under new product development team.
1. Unlimited leave policy
2. Health, Vision & Dental Insurance
3. Visa sponsorship if required
4. Stock options
Note Neolight participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
Additional Application InstructionsPlease send us an email to firstname.lastname@example.org that includes the following: A resume detailing your professional experience A cover letter (with specifics about your interest in this specific role, specifically with Neolight), A list of no more than 3 professional references (including their name, relationship to you, email address, and phone number)
Sign up for Job Alerts
Sr. Chef DevOps DeveloperRaytheonRichardson, TX, United StatesFeb 23
Android Developer, ProductShowtime Networks Inc.New York, NY, United StatesFeb 22
Manager, ProductShowtime Networks Inc.New York, NY, United StatesFeb 22
Product AnalystShowtime Networks Inc.New York, NY, United StatesFeb 22
Project Manager, ProductShowtime Networks Inc.New York, NY, United StatesFeb 22
Latest from the webjobs by
Software Integration EngineerBroetje Automation USA Inc.Chicago, IL30 Jan
Managing Broker and Contract to Close CoordinatorCatalyst RealtyAustin, TX24 Feb
Head of DesignWunderLand GroupSan Francisco, CA17 Dec
Senior Mobile Engineer in Quality - iOS/AndroidIntuitMountain View, CA 9403922 Jan
Web Developer & Tech Support position in fast growing companyLightcast.comCharlotte, NC1 Jan
Director, Validation TestTASER InternationalScottsdale, AZ, United StatesJan 30
Engineering ManagerDimagiCambridge, MAFeb 22
Software EngineerMagooshBerkeley, CA, United StatesFeb 15
Software EngineerIllinois Applied Research Institute - University of Illinois at Urbana-ChampaignChampaign, IL, United StatesFeb 07
Quality EngineerNeolightPhoenix, AZ, United StatesFeb 10