SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Senior Process Engineer, Assay NPI

Company: Illumina
Location: San Diego
Posted on: September 14, 2020

Job Description:

We are looking for a technical expert for our Consumables Process Development and Transfer (cPDT) group. The cPDT group works as an integral part of our Consumables Manufacturing process and is tasked with new product introduction and increasing quality and yield within our high-volume production environments.

This individual will be primarily accountable for representing cPDT on cross functional teams, focused on design transfers to Operations of new RUO and IVD library preparation, sequencing, and micro-array products. The role ensures best-in-class product quality and optimized cost of goods through proactive integration of risk-based design requirements, performance testing controls, and manufacturing strategies into the product development process. Additionally, this person will lead as appropriate enhancement of on-market products and enhance/develop risk-based design and transfer processes within cPDT.

This position on the Operation's team will enable the development of Illumina's core technologies and applications in one of the most technically innovative spaces in industry. The ideal candidate will have experience in representing Operations on cross functional project teams to ensure and enable the risk-based transfer, launch, and on market support of complex clinical diagnostics. The technical areas of expertise are broad including assay design, manufacturing process development, and QC testing.

Responsibilities:


  • Accountable for the operation's deliverables for new product introduction projects, ensuring best-in-class product quality and optimized cost of goods through proactive integration of risk-based design requirements, performance testing controls, and manufacturing strategies into the product development process.
  • Technical leader for ensuring risk-based product design, specifications, manufacturing process design, and post-launch metrics to create effective and reliable products
  • Ensure the projects meet the required design history deliverables as needed for clinical and RUO products
  • Collaborate closely across all of Global Operations to ensure a unified voice to the NPI core teams
  • With manager's oversight, provide operational support and content for Regulatory submissions and product instructions for use.
  • Assists with the resolution of non-conformances and complaints generated within the early launch period, and ensures lessons learned are incorporated into future product development programs

    Requirements:

    • Experience in transferring clinical diagnostic products from Development to Operations in a highly cross-functional environment preferred.
    • Experience with manufacturing process development, production, and QC testing of clinical diagnostics is preferred.
    • Experience with application of ISO13485, QSR, GMP/GLP, and FMEA/PFMEAs to product design, testing, and manufacturing is required.
    • System-level experience in integrating across multiple disciplines and new technologies.
    • Experience in leading resolution of multi-disciplinary, cross-departmental technical problems.
    • Demonstrated ability in collaborating with and mentoring technical staff.
    • Experience in high-volume production in a high-tech consumables industry is a plus.
    • Experience with statistics, Statistical Process Control and DOE techniques is preferred.
    • Problem solving, and reasoning skills required.
    • Excellent interdepartmental communication, influence and documentation skills are required.
    • Demonstrated ability to accomplish goals while working across departments is required.
    • Experience with manufacturing and testing process validation procedures is a plus.

      Education:

      • BSc/MS: 5+ years of experience
      • PhD: 0-3 years of experience


        Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

Keywords: Illumina, San Diego , Senior Process Engineer, Assay NPI, Engineering , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Structural Project Engineer
Description: If you are a Structural Project Engineer with experience, please read on Top Reasons to Work with UsWe provide a wide range of structural engineering consulting services to architects, owners, developers (more...)
Company: Optello
Location: Pasadena
Posted on: 09/18/2020

Engineer, IT Solutions
Description: WHO WE ARE: br br At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we (more...)
Company: Neurocrine Biosciences
Location: San Diego
Posted on: 09/18/2020

IAM Engineer
Description: JOB DESCRIPTION:Responsibilities--- Provide solution overview to the IAM leadership team, architectural guidance and hands-on implementation to the Identity and Access Governance team--- Demonstrate ability (more...)
Company: OSI Engineering
Location: Irvine
Posted on: 09/18/2020


Mechanic
Description: COMPANY OVERVIEW br Cadence Kitchen is a food technology company that combines culinary expertise, high-quality ingredients, and innovative technology to transform the way people access and prepare (more...)
Company: Cadence Gourmet LLC
Location: Corona
Posted on: 09/18/2020

Associate RF-Microwave Communications Subsystem Engineer
Description: Position Overview:Boeing Defense Space Security seeks Associate RF-Microwave Communications Subsystem Engineer to support the Satellite Capabilities organization and multiple satellite product lines (more...)
Company: Boeing
Location: Pasadena
Posted on: 09/18/2020

Adjunct Faculty - Bachelor of Science in Manufacturing Design Engineering
Description: Our mission is to deliver an exceptional student experience by providing superior programs and services that are relevant and result in meaningful learning. National University is San Diego's largest (more...)
Company: National University
Location: San Diego
Posted on: 09/18/2020

GCP Engineer
Description: Hello Hope you're doing great. We are currently looking for SCALA GCP Consultant for an immediate need.
Company: Ztek Consulting
Location: Irvine
Posted on: 09/18/2020

Mechanical Project Engineer
Description: TRC Companies, Inc., a pioneer in groundbreaking scientific and engineering developments since the 1960's, is a national engineering and environmental consulting firm that provides integrated services (more...)
Company: TRC Companies, Inc.
Location: San Bernardino
Posted on: 09/18/2020

Principal Design Engineer - Space Components
Description: Engineering Qualifications: At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to (more...)
Company: Northrop Grumman
Location: San Diego
Posted on: 09/18/2020

Senior React Engineer
Description: Job DescriptionA company based in Costa Mesa is looking for a Senior Front End Developer to take part in building their next application so people can purchase their products and services. As one of the (more...)
Company: Jobspring Partners
Location: Irvine
Posted on: 09/18/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds