Principal Consumables Design Engineer

Job description

·  Job facts

Join the genomic revolution! Roche Sequencing Solutions is unifying next-generation sequencing with the goal of making it routine: Sample in, result out. Sequencing using nanopores, tiny apertures on the cell membrane, offer several advantages over existing technologies that use sensitive optics or complex preparation methods to detect DNA sequences. Help us deliver a disruptive technology for Next-Gen Sequencing.

As a Principal Consumables Design Engineer, you will lead product development efforts on microfluidic & plastic injection components design, (e.g. flow cell, rubber, plastic, and final microfluidic device assembly and packaging), including development deliverables such as technology transfer, deriving specifications from formal product requirements and supporting verification development and other formal Quality Management System studies and documentation. The ideal candidate will have expertise in multiple areas – mechanical design using SolidWorks, consumables product development, documentation in a regulated environment (preferred), product transfer, and a natural curiosity to understand how mechanical/material properties of a device can impact product performance.

Responsibilities:

·  Design and lead design iterations related to consumables part design (plastic injection molded components, microfluidics, molded elastomers transfer, and sputtered substrates) to ensure repeatable/reproducible high volume product development.
·  Collaborate with Research Design Engineers to generate product configuration documentation such as specification and assembly drawings, BOMs with special focus on DFM/A, and GD&T analyses.
·  Design, fabricate, and implement new or improved MFG tools/fixtures for suppliers and for prototype manufacturing lines.
·  Generate technical documents, including IQ/OQ/PQ, SOPs, User Requirements Specifications, Design and Functional Specification, executed FAT and Site Acceptance Testing (SAT) verification, incoming inspections, COA/COC, test plans as well as final reports with deviations, as required
·  Develop novel inspection and verification procedures to verify custom assembly and process equipment are meeting design specifications.
·  Support quality compliance, MFG system test, and process improvement projects.
·  Execute failure analysis investigations, risk impact assessment, and root cause investigations.
·  Drive effective coordination between internal and external resources for product transfer.
·  Support the development and documentation of new methods and procedures for production processes such as automated inspection procedures.
·  Provide consumable device development expertise in support of yield, reliability, efficiency and quality improvements.
·  Support field and internal investigations.

Requirements:

·  Bachelor in Mechanical Engineering or related technical disciplines with a minimum 8 years of experience; or a Master with 6 years or PhD with 4 years.
·  Consumables design or product development experience with a preference for strong injection molded plastics, microfluidics, and transfer molding with elastomers experience.
·  Experience using and programming automated inspection instruments such as Micro-Vu, OGP, Keyence, Nikon, etc., is a plus.
·  Statistical data analysis using JMP, Minitab or other similar tools.
·  Experience with industry applied GD&T analyses for assemblies.
·  Medical device/biotechnology industry experience is highly preferred.
·  SolidWorks proficiency.
·  Excellent communication skills with a knack for creative problem solving while collaborating cross-functionally.
·  Some local/international traveling required up to 10%.

Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Operational Excellence

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.