V&V Manager (Verification & Validation)
NuProbe USA is hiring an Assay V&V Manager for its Houston (TX) location. NuProbe USA is a startup devoted to the development of affordable, accurate, and non-invasive DNA diagnostic assays for cancer and other diseases.
PRIMARY PURPOSE OF POSITION
The successful candidate will contribute to the development of Next Generation Sequencing (NGS) panels for detecting rare oncogenic mutations. Work is focused on the development of verification and validation (V&V) activities for multiple systems comprised of assays, reagents, consumables, instruments, and software. The role requires a strong detail-focused skill set to execute tests of products exiting development and to further support and improve products.
Essential Job Duties and Responsibilities:
Essential responsibilities and duties include, but are not limited to the following:
- V&V assays, reagents, and consumables.
- Works with V&V Manager to execute V&V studies.
- Executes ad-hoc testing to support pre-V&V activities.
- Executes testing protocols and generates reports.
- Supports product improvement and manufacturing optimization.
- Executes experiments and validation protocols, supports problem-solving and troubleshooting activities with guidance from Team Lead & Manager.
- Maintains detailed and organized notebooks and records.
- Participates in team environments and interacts with team members professionally; trains others as needed.
- Maintains good communication with supervisor and peers.
- Maintains safe working environment; Carries out duties.
- Manages, leads, and provides strong ownership of medical device software requirements and a rigorous process of verification, validation, change control, and release management.
- Works cross-functionally to develop and manage software requirements specifications.
- Develops and manages the software verification process and a library of test protocols.
- Develops and manages software validation activities.
- Provides systems engineering discipline and expertise to the development and troubleshooting of complex IVD medical systems comprising instruments, consumables, assays, and embedded software.
Job Qualifications and Education:
- Master’s degree in Biology, Chemistry, Biochemistry, Biochemical Engineering, or related discipline.
- 5+ years leading and managing requirements and V&V for bio-assay and bio-reagents, and for on-market products.
- Expertise in Design Controls and ISO 14971 Risk Management.
- Expert working knowledge of the product development cycle, risk management, systems integration, verification, validation, regulatory, and quality systems.
- Excellent verbal and written communication skills.
- Excellent interpersonal and collaborative skills.
- Highly proficient in systems integration principles, engineering tests, algorithm development test, requirements definition, use-case development, V&V, technical troubleshooting, and problem resolution.
- Strong experience as a systems engineer collaborating with assay development and software teams to develop high quality products.
- Strong experience with high quality software development and release processes.
- Strong organizational skills and attention to detail.
- Excels at multitasking while meeting challenging deadlines with a high level of attention to detail.
- Varied sitting, standing, walking.
- Ability to lift or carry up to 20 lbs
- Company benefits (medical, dental, vision, PTO, 401k and more).
- Professional growth: We believe in people, and we foster professional growth.
- Starting compensation will be based on experience.
NuProbe is willing to sponsor H1-b work visa for the successful candidate.
This job description describes the major responsibilities of the job. It does not include all aspects of the position, such as the potential additional duties assigned by management, and the requirement for flexibility in assisting others for the company’s overall benefit.
About NuProbe USA:
NuProbe is a genomics company with proprietary technology to reduce the cost and improve the sensitivity of NGS by 100-fold. NuProbe's technologies have been featured in journals such as Nature Biomedical Engineering, Nature Chemistry, Cancer Discovery, and Nature Communications, in collaboration with collaborators from MD Anderson, Baylor College of Medicine, Thermo Fisher, Oxford Nanopore, and Microsoft Research. To date, NuProbe has raised more than $60M, and its US office based in Houston, TX has over 50 full-time employees. NuProbe's senior management team includes industry veterans from Adaptive Biotechnologies, Thermo Fisher, Nanostring, Roche, and Allergan.