Manufacturing Engineer

Position Summary:

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.

Responsibilities:

 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.

Qualifications

 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.

Benefits

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