Roche is seeking a motivated Senior System 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.
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.
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
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.
Job Level:Individual contributor