Offers “Roche”

Expires soon Roche

Senior Product Engineer

  • Santa Clara (Santa Clara)
  • Sales

Job description

·  Job facts

Description:

We are seeking a motivated and team-oriented individual to support development of complex consumable devices based at Roche's site in Santa Clara primarily for nanopore sequencing technology across the Roche Molecular diagnostics business. This role will be responsible for delivering a steady supply of quality materials to the prototype manufacturing line for product development of consumable devices, from feasibility through verification and into technology transfer for launch as an RUO/IVD product. The candidate will work closely with the design and process development teams, global operations and outside OEMs as a key member of the team to optimize and maintain quality materials for scale up of global commercial launch.

Responsibilities:

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Support the development of product specifications and tolerances, product and technical requirements, design and process FMEAs for the Consumable Device Bill of Materials [BOM]

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Establish and maintain control plans and inspection standards to assure critical features are controlled through the assembly / production processes

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Establish and maintain supplier quality performance metrics

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Develop continuous improvement plans (CIP) on existing manufacturing processes to increase first pass yield

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Implement industry standard process control techniques such as six sigma/lean manufacturing, value stream mapping to manage and develop production efficiency and quality

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Perform capability test on new parts through multiple manufacturing processes with the use of statistical data analysis and durability testing.

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Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.

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Establish statistical confidence by identifying sample size and acceptable error; determining levels of confidence.

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Audit suppliers for manufacturing “process of record” and supplier's “quality management systems” including change control procedures

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Conduct effective supplier visits, both domestic and international, in evaluating and managing new and existing suppliers

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Coordinate and collaborate with multidisciplinary teams to investigate and resolve issues affecting product quality.

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Lead and direct meetings with other team members

Qualifications:

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Minimum education: BS degree in Mechanical Engineering or equivalent

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3+ years experience in quality systems in a manufacturing environment or a similar role.

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Specific training and demonstrated success in applying quality problem solving methods such as fishbone diagrams, Root Cause-Corrective Action (RCCA), FMEA, process capability analysis, hypothesis testing, DOE, SPC, etc.

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Experience in lean manufacturing practices

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The ability to read engineering drawings and identifying manufacturing limits at suppliers

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Experience with broad variety of measurement and inspection techniques including precision hand tools, noncontact optical sensor systems, and vision systems

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Fundamental knowledge of overmolding technologies, optical imaging, material characterization, surface analysis, and thin film technologies.

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Ability, willingness to travel domestically and internationally (up to 25%)

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Must be detail oriented, effectively handle multiple priorities, have a strong quality mindset and have the ability to meet tight deadlines

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Excellent oral, written and presentation communication skills

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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .

·  Who we are

At Roche, 100,000 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.

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