Basic Function and Scope of the Position:
You will work in a fast-paced and team-oriented environment to drive the development of genomic analysis tools that enable leading-edge research. You will be a key contributor to integrated and multidisciplinary teams, developing new, and improving existing, technology platforms. You are responsible for the mechanical & fluidic design and development of hardware consumables for Illumina’s genetic sequencing products. You are a highly motivated individual with the ability to work cross-functionally in areas of fluidics, optics, and biochemistry, and adapt quickly to changing roles throughout the product development process - from early innovation and architecture stages through manufacturing transfer and commercialization
Tasks and Responsibilities: - Drive requirements definition and architecture development for complex, high precision consumable/disposable products in conjunction with cross-disciplinary project team that includes Marketing, Instrument, Chemistry, Manufacturing, Quality and Supply Chain.
- Work with experts in microfluidic, optics, thermal, motion control, bioinformatics, chemistry and others to achieve an optimized system.
- Conceptualize, design, analyze, fabricate, test and qualify the consumables.
- Perform detailed engineering analysis, including tolerance, dFMEA, FEA and DFx.
- Identify and characterize appropriate critical parameters to achieve high reliability and robustness and lifetime performance.
- Lead technical teams to troubleshoot, developing characterization tools, identifying root cause and implementing corrective action.
- Evaluate or develop packaging solutions for sterile and non-sterile products.
- Drive selection and qualification of critical suppliers/partners for parts, tooling and manufacturing.
- Define specifications, test plans, SPC metrics and QC approaches.
- Resolve early production issues to stabilize quality and yield.
- Manage the transfer of development to Manufacturing.
- Travel to US HQ and vendor sites for training and development.
Preferred Experiential & Educational Background:
- Bachelor or Master Degree in Mechanical Engineering.
- Minimum 10 years of experience in the design and development of precision plastic containers or fluidics parts and assemblies with complex structures and shapes.
- Proficiency in CAD with a demonstrated ability to design, build, and test prototypes.
- Demonstrated broad experience in plastics materials. In-depth knowledge of precision tooling and injection molding.
- Good knowledge of packaging solutions and sterile packaging activities.
- Experienced in product development with significant human factors considerations; from requirements definition, analysis/modeling, architecture, part design, integration and testing/validation.
- Demonstrated experience with experimental design and troubleshooting, with a track record of leading root-cause investigations and driving to resolution.
- Knowledge of FDA and cGMP requirements for medical device product manufacturing a plus.
- Experienced in supplier management from selection through qualification.
- Highly collaborative and have good communication skills.
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.