At Genapsys we are working to transform the human condition by building an affordable, scalable genomic ecosystem that empowers research and diagnostics. Powered by semiconductor chip-based electronic sequencing technology, our platform will be a modular and accessible system that will enable highly accurate, scalable, and affordable sequencing for a variety of applications. We believe in a world where every researcher and clinician can perform their sequencing on-site, enabling easy and rapid access to actionable insights based on genomic data. Join us and let’s work together to unlock universal access to genomic sequencing.

About the Role:

This position is responsible for managing the Verification and Validation (V&V) activities for the entire product. The Senior Manager, Verification & Validation will be responsible for a risk based test strategy, test planning, authoring test procedures and test cases, and ensuring that each product requirement and specification gets verified. This role will manage the defects arising from the execution of the test cases and collaborate cross functionally to drive them to resolution. 

This role requires strong project management skills and a solid understanding/willingness to quickly learn the various components of our product (instrument, hardware, software, electrical, sequencing chemistry etc.). A strong understanding of the design and development process and various testing methodologies and familiarity with quality regulations and standards (21 CFR 820, ISO 13485, ISO 14971, IVDD/R) are needed.

Responsibilities: 

• Develop and implement testing methods and best practices that allow high quality NGS instrument and software products to be designed, developed, and released.
• Develop KPI metrics to actively measure product quality and implement quality tracking tools and methodologies to provide on-going visibility and action during product development lifecycle.
• Partner with leadership, functional and program managers to identify appropriate scope of testing, verification and validation required for a project, and managing the overall testing activities for projects.
• Manage the definition of test methods and the creation of test plans to ensure it will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions.
• Maintain effective communication with the engineering, quality & regulatory, operations, and leadership on product risks, quality status, and progress.
• Promote agile development best practices and test-driven development culture.

Qualifications: 

• Minimum 10+ years experience performing verification and validation testing, preferably in the medical device/ biotech space.
• Bachelor’s degree in a scientific or engineering discipline required; advanced degree in science, quality, and/or business strongly preferred.
• Practical experience as a leader in the use of modern development methodologies/ processes with an ability to direct the use of resources to meet department goals.
• Experience leading cross-functional, multi-site teams.

What we offer (US based-employees):

• Competitive compensation and generous stock options.
• Comprehensive, industry-leading medical, dental and vision benefits for employees and dependents.
• Pre-tax savings plans for health care, child care, elder care, public transportation and parking expenses.
• 401(k) retirement plan with matching employer contribution.
• Free daily catered gourmet lunches and snacks.
• For those emergency moments – long and short-term disability, life insurance (2x salary) and an employee assistance program.
• Work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, the opportunity to work on problems that matter in a highly collaborative environment.
• Flexible working environment

At this time, we can only consider applicants with authorization to work in the United States on a permanent, full-time basis; unfortunately, we cannot provide visa sponsorship.

A diverse and inclusive workplace where we learn from each other is an integral part of Genapsys' culture. We actively welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a great place to work. Join us and help us achieve our mission!

Genapsys has a robust COVID-19 prevention plan in order to keep our team members as safe as possible. This plan includes a requirement that all employees, contractors and visitors are fully vaccinated against COVID-19 (or receive an approved medical or religious exemption) prior to working on site at any Genapsys location. Please contact [email protected] if you have any questions.