Job details
Job type full-time
Full job description
Position summary:
Position summary:
The clinical support field systems integration engineer (fsie) position is remote/field based position where the individual will be responsible for all aspects of clinical products’ lifecycle at the start of field involvement, during clinical trials/pre-commercialization studies, initial clinical platform/product implementation support, and will be expected to provide second-level support to the front-line colleagues in the entire amr regions.
The clinical fsie partners with internal teams and external customers to provide support on new products during clinical trial/pre-commercialization studies, troubleshooting, and complaint resolutionThis position serves as an engineering expert for clinical products and will collaborate with broader commercial/internal teams to develop processes, tools and resources.
The successful applicant will be part of an award-winning customer support team that leads the industry in customer satisfaction, and participate in the support on illumina/partnered sample preparation platforms, illumina sequencers, focusing on the processes, including reagents and networking involved in the entire system setup (i.e., hardware/software/fluidic integration) workflow.
Responsibilities:
Perform installation, integration, implementation and performance monitoring of new clinical/diagnostic sequencers developed/launched in amr.
Manage, coordinate, and/or support complex, large-scale clinical customer implementation, including facility inspections and instrument validation.
Operation of instrumentation, setting up initiating runs/pq, and managing data at the systems integration level.
Assists by providing feedback/input on design for serviceability and supportability of engineering activities on clinical products
Executing system integration test protocols in collaboration with development/product testing group & supporting the design improvement by providing feedback pre and post launch.
Execute study protocols following good lab practices to align with illumina’s quality procedures to support on-market changes and product improvements as needed.
Assist with internal investigations into technical complaints on existing/new clinical platform issues.
Integration of system components, networking, test and characterization of the interaction of components.
Record instrument anomalies and provide them as feedback to the appropriate software research and development (r&d) groups on new sequencers/platforms.
Identifies, confirms and interprets interacting causes & effects behind instrument issues, discrepancies, problems or complaints in accordance with governing procedures
Perform all duties in compliance with appropriate regulations and company policies
Maintains effective communications within clinical support team, amr s&s & leadership
Listed responsibilities are an essential, but not exhaustive, list of the usual duties associated with the positionChanges to individual responsibilities may occur due to business needs.
Requirements:
6+ years biotech/medical device industry work experience preferred.
Experience working in a medical device organization and with regulated (fda approved, as well as ldt) products and requirements.
Familiar with or developed system architecture requirements and specification.
Familiar with/understand electronics and sw specifications
Experience with lab or liquid handling automation platforms/workflow is a plus and preferred.
Strong knowledge of illumina sequencing platforms and work experience on illumina methods that apply to our technology.
Proficient in operation of instruments, and repair/replacement of parts/subassemblies.
Excellent planning and organization skills
Analysis of problems and synthesis, and proven ability to resolve complex customer issues while maintaining positive customer relations.
Exceptional written, verbal communication and presentation skills preferred.
Ability to operate as an independent contributor and as a cooperative member of a team in a fast paced, rapidly changing environment.
Clear vision and commitment to providing outstanding customer service & support.
Capacity to maintain composure in stressful situations.
Good lab practice, pc skills (word, excel, powerpoint); data representation.
Presents, delivers and interprets information amongst product team members, scientists, engineers, and other systems development personnel.
Must be willing to travel up to 50%.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities
Experience/education:
B.s or m.s in bio-engineering, bio-medical engineering, engineering or related discipline preferably with background in instrumentation development with at least 5 years of work experience in the industry.
Concerns regarding covid-19 continue as positive cases are experienced in the communities in which we operatePlease be aware that, as a condition of employment, illumina requires proof of covid vaccination for all u.s.-based employees (subject to limited exceptions) beginning november 1, 2021.
At illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our missionBuilt on a strong foundation, illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomicsWe are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or raceWe also have several employee resource groups (erg) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and workWe 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 informationIf you require accommodation to complete the application or interview process, please contact accommodations@illumina.comTo learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
