Senior Systems Integration Engineer

United States of America, California, Santa Clara

de fr es ru tr it pt zh ja

Roche is seeking a motivated Senior Systems Integration Engineer who is passionate about the possibilities of next-generation sequencing. Working with cross-functional teams, you will play a key role in the successful transition of the technology into the product phase. As a Senior Systems Integration Engineer, you will become an expert in the theory of operation of the nanopore DNA sequencing and sample preparation platforms and will contribute to system development by participating in characterization, investigation, optimization, integration, and verification activities. You will also obtain a thorough understanding of the Roche Quality Management System. By drawing on your experience in product development and design controls, you will help ensure that the right processes are in place and will guide the project teams through the product development process from planning and execution to deployment. 

Responsibilities 

  • Collaborating with scientists and engineers to analyze and create technical requirements and design specifications

  • Collaborating with cross-functional teams to identify and document design and process risks

  • Becoming a subject matter expert in Roche directives, standards, and guidelines and  assure development activities conform to them.

  • Reviewing existing product development process documents, performing gap assessments, and working with Design Quality Assurance and other process experts to resolve issues.

  • Coaching teams on product development process and design controls.

  • Participating in design verification planning

  • Authoring or participating in authoring verification plans, protocols, and reports

  • Executing design verification activities

  • Leading or participating in test method development and verification

  • Contributing to system development by participating in characterization, investigation, optimization, and integration activities

  • Analyzing experimental data and presenting information results

  • Contributing to creation of system architecture documentation

Qualifications

 Come join us if you’re looking for a company where you have the opportunity to pursue your interests across functions and disciplines and grow professionally. In our team, a job title is not considered the final definition of who you are, but the starting point. We are looking for someone who has:

  • Degree in mechanical engineering, bioengineering, biomedical engineering, or systems engineering. Different degrees with relevant experience will be considered

  • Bachelor's degree with 5+ years of applicable industry experience, Master’s degree with 3+ years of applicable industry experience, or Ph.D. with relevant academic experience

  • Experience in hardware development and verification in a regulatory environment; medical device experience preferred

  • Proven ability to identify, assess, and solve problems

  • Strong soft skills for persuasion

  • Experience with failure modes and effects analysis (FMEAs)

  • Experience with test method development

  • Experience with design verification activities including writing protocols and reports, and study execution

  • Working knowledge of statistical methods and design of experiments (DOE)

  • Working knowledge of design controls and product development process

  • Working knowledge of data analysis; JMP, Python, or R preferred

  • Strong analytical skills

  • Strong written and verbal communication skills to interact with technical and non-technical audiences

  • Ability to work independently and to establish work priorities and direction Familiarity with the Standards, Regulations, and FDA Guidance documents (ISO 13485, 21 CFR Part 820, IEC 62304, TIR45)

  • Familiarity with microfluidics systems preferred

  • Experience with nucleic acid extraction techniques, DNA library preparation, and DNA sequencing preferred  

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.