High growth, pre-IPO company in stealth mode
Join a rapidly growing company that is developing ground-breaking genomics technologies that will push the boundaries in the clinical, life sciences research and therapeutic fields. We are well-funded by global top-tier investors, including venture capital firms and growth equity investors. Our team brings together unique and diverse expertise across multiple disciplines, from healthcare and life sciences, to engineering, to technology and software and beyond. We are a collaborative group of more than 200 employees, including successful entrepreneurs, hardware and software engineers, genomics and biotechnology experts, molecular and computational biologists, software and algorithm experts, and operations and commercial leaders. Play an important role in the development and commercialization of technology and products that will accelerate our understanding of life, biology and disease and transform large industries.
We are looking for an exceptional Senior Systems Integration Scientist, Platform Development to join our team!
The Platform Development organization is responsible for developing an integrated platform & workflow, establish performance metrics and processes for each system within the end-to-end high throughput genomics workflow decomposed from high level customer and application requirements. As well as to characterize and mitigate how each system affects upstream and downstream steps to ensure a robust platform, and ultimately crafting the verification and validation strategy of that platform in support of commercialization.
You are a creative and curious systems integration scientist that seeks to understand and resolve any interdependencies and interfaces within a high throughput system comprised of hardware, software, reagent and consumable components to produce a reliable and optimally performing system. Spending time digging into the data analysis of system and manufacturing metadata against functional performance and designing experiments to understand how the system components impact the downstream and upstream workflow steps to maximize the performance of our system is exciting and motivating to you!
Using these skills, with a specialty in sample preparation and amplification, you will partner with the reagent, kit development and systems engineering teams to develop, troubleshoot and release new reagent formulations and protocols, with a special focus on ensuring the integrated system of reagent, hardware, software and consumables are optimized, as well as developing and mitigating risk analyses for genomic applications and workflows across an end to end platform.
How You'll Contribute
- Lead the development of which metrics should be used, as well as the nominal and tolerances for new reagent formulations, enzyme variants and process recipes to be released to baseline
- Support the design and systems engineering teams in the discovery of CtQ’s (Critical-to-Quality) parameters that correlate with functional performance
- Partner with the design and systems engineering teams to document and establish how new formulations, enzyme variants and recipes are to be released to platform baseline, with particular focus on testing and de-risking schemas to ensure interdependencies/interfaces are mitigated
- Develop data visualization tools and KPI’s through extensive characterization with support from the System Analytics organization to assist in rapid decision making
- Present data visualization charts to ensure over time and with new releases that critical to quality (CtQ) and functional metrics are improving
- Involvement in the day to day troubleshooting and integration efforts, with a focus on broader system and platform impacts on key customer requirements
- Lead the team in the development of a verification strategy for each component as well as for the complete system of reagents, hardware, software and consumables
- Responsible for leading the design and systems team in the decomposition of customer requirements into system and component specific product and technical requirements
- Drive risk assessment activities such as the development of dFMEA and pFMEA activities
- Development of verification test protocols and methods, as well as requesting software elements needed in support of all verification and validation testing
- Tracking of test cases against requirements and specifications to ensure full test coverage
- Execution of verification test protocols and associated reports
- Work independently on multiple projects and effectively communicate to project stakeholders
Qualifications, Skills, Knowledge & Abilities
- BS, MS or PhD in Biochemistry, Molecular Biology or similar are most relevant.
- Preferred if the applicant has experience in molecular diagnostics, genomics technology, molecular device company or similar
- 8+ Years experience in reagent development, sample preparation and/or amplification process development
- Demonstrated ability to thrive in multi-disciplinary and cross-functional teams
- Experience developing a medical device is preferred
- Demonstrated mastery of risk assessment and root cause analysis tools (FMEAs, 5-Why’s, Fishbones, etc)
- Experience with design verification activities including test method development, writing protocols and reports, and study execution
- Working knowledge of design controls and product development process
- Experience in characterization, implementing and leveraging metrics
- Working knowledge of data analysis; JMP, Python, or R preferred
- Familiarity with the Standards, Regulations, and FDA Guidance documents (ISO 13485, 21 CFR Part 820, IEC 62304, TIR45) is preferred, but not required
- Adaptable to fast-paced, dynamic work environment and shifting demands
- Extremely strong communication, interpersonal skills and customer focus
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