Manufacturing Engineer 2 at Illumina, Inc. in Hayward, California

Job Description:

Summary

Exciting opportunity for a Manufacturing Engineer working on the latest technology within Illumina’s growing and revolutionary Factory Sequencing Instrument portfolio.  The Manufacturing Engineer will seek out and resolve problems affecting the performance of the manufacturing operations organization and execute projects varying in size and complexity improving quality, manufacturing productivity and cost.  The Manufacturing Engineer will interface with internal and external partners to rapidly investigate problems, develop countermeasures, and prevent recurrence.  In addition to the criteria below, the ideal candidate must be self-motivated, be able to work independently, work on multiple tasks in parallel and communicate effectively across all site teams (Manufacturing, Supplier Quality, Engineering, Supply Chain).

Description

Responsibilities:

• Seek out and lead problem-solving efforts to improve the performance of sequencing instrument manufacturing operations (Safety, Delivery, Quality, Productivity, Cost).


• Lead investigation and resolution of complex technical problems with minimal direction.


• Identify risks and recommend risk mitigation to maximize manufacturing operations performance.


• Responsible for manufacturing sustaining efforts necessary to achieve continuous improvements, minimize manufacturing variation, and increase first pass yield.


• Create requirements, plan activities, and develop budget necessary for large projects.


• Troubleshoot system-level functional problems (supplier defects, manufacturing defects, design defects, etc.) for existing and legacy products.


• Drive collaboration with cross-functional teams (design, manufacturing, process, quality, regulatory, supply chain) to rapidly implement corrective and preventative actions.


• Lead and coordinate MRB (Material Review Board) activities such as material disposition and rework procedures.


• Maintain a collaborative environment and build relationships across disciplines, sites, and work groups.


• Develop, lead and manage engineering change requests necessary to avoid recurring defect occurrences.


• Present technical information with clarity, conviction, and confidence.


• Represent manufacturing in project teams to ensure new designs are compatible with best manufacturing practices.


• Participate in NPI transfer efforts to manufacturing.


• Support Customer and Field issues pertaining to existing and legacy products.


• Complete Non-conformance and Quality Investigation Records based upon thorough investigations and rapidly drive the release of instruments back to normal production.

Requirements:

• B.S./M.S. in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Bioengineering, Biomedical Engineering, or equivalent with 1+ years of relevant experience.

Preferred experience:

Demonstrated experience with manufacturing, testing, and troubleshooting of complex electromechanical assemblies.

• Experience in the medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods


• Demonstrated ability to use statistical tools in data analysis and problem solving.


• Demonstrated strong analytical problem solving (CAPA), team and communications/interpersonal skills


• Strong analytical skills, problem solving and troubleshooting.


• Experience in various analytical techniques such as FMEA, GR&R, DOE etc.


• Previous use and understanding of change management processes and PDM/PLM software.


• Strong written and oral communication skills


• Self-starter who prioritizes own work with minimal guidance.


• Lean Six Sigma certification a plus.


• Experienced in GAMP 5 and 21 CFR Part 11

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.  All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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