At GenapSys we are working to power the world of healthcare and diagnostics with advanced DNA sequencing technology. Our sequencing instrument platform leverages a proprietary electrical microfluidic sequencing chip with a scalable number of detectors, enabling a wide range of applications including targeted sequencing in oncology, pharmacogenomics and genome-wide sequencing in microbiology and others. We believe in a world where every researcher has a compact, scalable, and affordable sequencer in their own lab, empowering the democratization of genetic sequencing. Our novel sequencing method is revolutionizing genomics discovery, biomedical research, healthcare, diagnostics, agriculture, and a variety of other fields.
Our team brings together an incredibly diverse and multidisciplinary set of backgrounds and skills – from electrical and mechanical engineers, physicists, chemists, microfluidic engineers, molecular biologists, bioinformaticians, mathematicians and more. It is a super exciting time to join GenapSys as we recently launched our first product which is generating a tremendous amount of interest.
About the Role:
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.
Bonus Points If:
- 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 (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.
*Eligible international employees’ benefits are specific to their location and dependent on their employer of record
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 absent a formal agreement.
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!