Senior Process Engineer, Assay NPI
Location: San Diego
Posted on: September 14, 2020
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.
- 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
- 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
- Experience in transferring clinical diagnostic products from
Development to Operations in a highly cross-functional environment
- 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
- 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
- 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.
- 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 email@example.com. To learn more,
Keywords: Illumina, San Diego , Senior Process Engineer, Assay NPI, Engineering , San Diego, California
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