At GenapSys we are developing a DNA-sequencing technology that will revolutionize the world of healthcare and diagnostics. 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!
This is an exciting opportunity for a Manufacturing/NPI Engineer to receive new sequencing and automated workflow instrument products from R&D, develop assembly, test methods, and documentation for Manufacturing, and transfer the products to an external Manufacturing CM.
- Collaborate with R&D Engineers to receive and evolve instrument assembly methods, work instructions, assembly drawings, BOMs, test methods, and test fixtures.
- Conduct internal pilot manufacturing builds of instrument products and test methods; this will be hands on work, but will likely include training and supervision of technicians
- Influence instrument designs toward low cost manufacturability by providing feedback to Design Engineers through all phases of development
- Analyze failures, derive and report statistical analysis such as Mean Time Between Failure (MTBF), work with mechanical, electrical, and/or software design engineers to identify the root cause, and recommend and verify corrective actions.
- Create ECOs to release and update designs through our PLM to the CMs
- Train external CMs in product assembly, test, and troubleshooting methods; this will likely require travel to local and global CM sites for up to a few weeks at a time.
- Support CMs in final validation of Mfg process
- Perform final integration and test of initial instruments produced by external CMs
- Track, summarize, and regularly publish metrics, such as yield and pareto of defects and failures
- Drive to maximize throughput and yield and minimize failures.
- May include quality inspection of parts and development of inspection processes
- May include conducting or supervising subassembly builds and kitting of parts for CMs
- Maintain organization of internal Pilot Manufacturing area.
- B.S. in Engineering, preferably Mechanical
- At least 5 years of post academic, pertinent experience, driving successful introduction of reliable Life Science laboratory instrumentation products to the market as a Mfg or NPI Engineer.
- A demonstrated track record of successful, on-time execution of relevant responsibilities.
Relevant Skills and Experience:
- Experience building systems including small and microfluidic components and systems (e.g. complex manifolds and chips), fluid, pressure, and mechanical sensors, small liquid isolation and selector valves, electromechanical components, mechanisms, and assemblies, liquid and air pumps, heaters, cooling systems, stepper motors, and electronic/firmware controls through custom PCBAs.
- Experience with small, fragile parts, including tubing and fittings, wire crimps, and soldering PCBA components
- Ability to analyze and apply understanding of mechanical and electrical designs, software and firmware code, algorithms, and interfaces, to efficiently troubleshoot and resolve issues. This includes the ability to use software tools to open and review mechanical CAD, fluidic schematics, electrical schematics and layouts, firmware and software code, and algorithms.
- Solid Works for creating assembly drawings
- Data collection tools, such as LabView.
- Experience with SOPs, Travelers, Device History Files, Deviations, ECOs, and GMP.
- Sound analytical reasoning, judgement, and problem-solving skills.
- Innovative, independent, driven, results-oriented, accountable, with a sense of ownership.
- Methodical, data driven, and comprehensive, yet flexible and able to easily adjust to evolving requirements and navigate in a fast-paced environment to meet tight schedules.
- Effective and proactive written and verbal communication skills.
- Ability to effectively and efficiently collaborate within a cross-functional array of engineers, technicians, scientists, users, suppliers, service, and manufacturing CMs.
Preferred Additional Experience:
- DNA Sequencers, related automated workflow instrumentation, and applications.
- Quality Control principles and methodology, bringing medical device instrument products to market in under an ISO 13486 compliant Quality System
- Data analysis tools.
- Mechanical and electrical design.
- Firmware and/or software design and coding, programming in Matlab, Python, and C++.
- Risk management tools (such as FMEA)
- DOE and Six Sigma methodology
- Advanced root cause analysis tools (such as Fishbone and 5 Whys).
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.