NPI Engineer

Employer
GenapSys
Location
94063, Redwood City
Salary
DOE with Benefits, Daily Catered Lunch, Learning opps!
Posted
Jun 25, 2018
Required Education
Bachelors Degree
Position Type
Full time

At GenapSys we are working to change the world of healthcare and diagnostics. We are developing a DNA-sequencing technology that will revolutionize the world of healthcare. Our system will enable fast, accurate, and ultra-low cost genetic tests in order to better understand (and ultimately treat) genetic diseases such as Cancer, Parkinson’s, Diabetes, and Alzheimer's, just to name a few.  GenapSys was founded by Dr. Hesaam Esfandyarpour and incubated over 6 years (2004-2010) at Stanford University.

Our team brings together an incredibly diverse and multidisciplinary set of backgrounds and skills – from electrical and mechanical engineers to physicists, chemists, microfluidic engineers, molecular biologists, bioinformaticians, mathematicians and more. Together we will advance scientific and medical knowledge and improve human health through cheaper, faster, and more accurate DNA sequencing technologies. We are working cross-functionally to make a great impact in the world – join us on that mission!

We’re looking for a talented and passionate team player to join our fast-paced startup company. The ideal candidate will be dedicated, hard-working and have a passion for building something different that can impact medical research and patient care.  If you want to help change the current paradigm of DNA sequencing, please apply! 

Responsibilities

Responsible for the introduction of new products into Manufacturing and Manufacturing processes (internal or external)

  • Serve as the liaison between Operations and design teams (reagents and hardware) on new development programs
  • Develop and manage transfer projects between GSYS and contract manufacturers (reagents and hardware)
  • Partner with Engineering to develop and execute validation protocols
  • Develop stability studies, performance, acceptance and quality criteria
  • Ensure all product BOMS are released and complete in PLM system
  • Manage internal/external prototype and pilot formulation, filling, and manufacturing
  • Develop component specifications for all items, including acceptance and inspection requirements
  • Create and qualify product packaging as needed
  • Determine lot tracing requirements for products and components
  • Create process instructions, methods and routings
  • Create Device History/Batch Record requirements and process.
  • Create process to track field issues related to manufacturing and components
  • Drive product cost improvements through process efficiencies and value engineering
  • Create and manage process to track and trend in-process failures and analysis
  • Technical point of contact with CM’s
  • Manage change issues, revisions, new releases
  • Manage in-process manufacturing performance
  • Partner with CM to resolve technical issues with suppliers
  • Partner with suppliers to understand process-oriented cost drivers and reductions

 Required Qualifications

  • Bachelor’s degree in biological sciences or related field
  • 7 years experience in reagent process development and reagent manufacturing environments
  • Prior experience in an FDA or ISO regulated environment preferred
  • Must be process oriented with a hands-on, entrepreneurial work ethic
  • Excellent technical writing skills, ability to create documentation for users of all levels
  • Ability to communicate effectively at all levels of the organization and the supply base
  • Project management capability (short and long-term) and self-direction is critical

What we offer:

  • An amazing mission: Enabling everyone to decode the living world!
  • Competitive compensation and stock options
  • Competitive benefits: medical, dental and vision benefits for employees and dependents, fully sponsored life, short and long-term disability insurance, and 401(k) retirement savings plan.
  • Free daily catered gourmet lunches and snacks
  • Weekly fancy High Tea and happy hours   
  • Free complex onsite gym membership
  • Casual, but high-performing work environment

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!

Note to Recruiters and Placement Agencies:

Genapsys does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any Genapsys employee. Genapsys will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered the property of Genapsys.