Job Description

Job Title:

Sr. NPI Technician

Reporting to:

Manufacturing Manager

Location:

Carlsbad, California

Job Site:

On-Site

Job Description Revision Date:

May 23, 2024

About us:

We know what it takes to be a key partner in the life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.

What You’ll Do:

As a Sr. NPI Technician, you will be responsible for developing and prototyping new products or processes in the Carlsbad Consumables Manufacturing group and support the transfer into manufacturing by performing the following duties. This is a heavily hands-on position which will provide advanced commercial control and readiness activities for our manufacturing. This position specializes in developing, implementing, and executing test processes to ensure product(s) meet appropriate internal and industry standards. This position is responsible for unit build and test, failure investigation, conducting calibration, and validation of equipment and systems. This position reviews and assesses processes and procedures, makes recommendations for changes and/or improvements, and troubleshoots ultrasound transducer manufacturing processes for future improvement. This position will report to the Manufacturing Manager, with dotted line to the NPI Project Manager.

Job Responsibilities:

• Participate in the design and development of new concepts.
• Build prototypes and evaluate new design/ideas and processes.
• Perform in-vitro/bench tests and document results.
• Document relevant information (i.e., new idea, test results, build procedure, etc.) to lab notebooks according to good laboratory practices or company procedure.
• Work with minimal guidance to perform engineering unit build and test or failure investigations on samples and document technical findings
• Proactively recommends new ideas and/or improvements pertaining to equipment, fixtures, tools, and process improvements.
• Support development, implementation, and execution of the testing and validation of all phases of product development and manufacturing.
• Support test procedures to ensure product(s) meet appropriate internal and industry standards.
• Conduct calibration and validation of equipment and systems.
• Support engineering documents and manage DCOs (Document Change Orders)
• Understand various workflows and manufacturing processes to identify potential problems and propose solutions.
• Use considerable judgment, a high degree of taking initiative, creative approaches in troubleshooting, and adapt to rapidly shifting priorities in a fast-paced environment.

What You’ll Bring:

• HS diploma and a minimum of 8 years related experience; AA degree and a minimum of 5 years’ experience preferred.
• Familiar with R&D and Manufacturing equipment (hot boxes, adhesives, soldering, bonding, fuse joining), experience in Consumables and Medical Manufacturing a PLUS
• Knowledge of materials (Polymers, Metals, Chemicals) as related to medical devices.
• Testing, Familiarity with: Tensile, balloon testing, fatigue or tests related to the project.

Skills (Required)

• Perform failure analysis with minimal supervision.
• Ability to use measurement devices and inspection systems.
• Manual soldering capability for small scale device under microscope
• Assemble and prepare test samples and devices as per approved process.
• Execute engineering tests per test protocols or approved process.
• Strong verbal and written communications
• Maintain safety protocol while working with hazardous materials.
• Design and create fixtures using 3D CAD tools (nice to have)
• Maintenance of engineering inspection equipment (nice to have)

• Proficiency with MS Office (Word and PowerPoint for generating engineering documents)
• Generate reports and presentation slides
• Experience creating sketches and 3D CAD models is a plus
• Sectioning work on ceramics is a big plus

Working Conditions:

Position requires gowning procedures for a controlled environment. Typically works around high-speed machinery, hydraulics, electric, and pneumatics requiring Lockout Tag out Procedure to be followed and close attention given to safety. May require the use of eye protection, as needed and hearing protection when working in high noise level area. Additional PPE may be required, i.e. gloves, face masks, face shields, depending on the specific job being performed and company safety rules and regulations.

• Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.
• We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.

Company Benefits:

Health, Dental and Vision insurance; 401(k) and 401(k) matching; Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.