Senior Product Development Engineer (M/F)
Opportunity and Challenges
We are looking to assemble a team of best-in-class, innovative and passionate people. We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write”. We offer the opportunity of joining a dynamic, international and highly skilled team in a pioneering startup. Our DNA Synthesis platform will not only have the potential to change the way the world makes and uses synthetic DNA but will also accelerate the rate of discovery by delivering upon the promise of same-day results.
DNA Script is looking for an experienced Product Development Engineer to join our team, in a role that is focused on improving and expanding the capabilities of the company’s core synthesis platform. The candidate will be responsible for managing and improving the platform’s design documentation and ensuring product requirements clearly trace through to specifications and verification & validation protocols.
The candidate is expected to lead requirement generation, development of acceptance criteria and verification test cases, risk analysis, generation of specifications and participate in efforts to design improvements to the system. Additionally, the candidate will work collaboratively with the R&D team in Paris, engineering partners and software development.
The candidate will join a global team bringing together scientists from various fields of expertise. We are looking for a person who is rigorous, well organized and detail-oriented. Pro-active, the candidate should be a problem-solver and should have a strong ability to think “out of the box”, as well as willingness to suggest and to prove out new ideas.
The position will be based in the South San Francisco, California office.
- Work closely with program management, field support, software and hardware teams to understand requirements, contribute to product improvements and new design activities, and develop associated verification and validation test criteria and procedures
- Maintain traceability for on-market products between test reports and requirements, specifications, failure modes analysis, and CAPAs, throughout design controls.
- Write and maintain design history file documentation
- Write test protocols, conduct feasibility, verification, and validation testing, and record results in a clear, concise, and compliant manner.
- Lead & perform efforts involving system robustness & stability. Conduct root cause analysis investigations; identify failure modes and resolutions.
- Conduct periodic risk management reviews, updating design, process and use FMEAs.
- Ensure all aspects of product testing and execution are performed within pre-specified program plans (including documentation such as protocols, reports, statistical analysis, deviations, root cause investigations).
- Ensure that the product meets performance requirements, intended use, and user needs by
conducting engineering tests, inspections, stability tests, and usability tests to evaluate individual components, subsystems, or the overall design.
- Establish and maintain schedules to meet critical milestones.
- Work with 3rd party vendors and cross-functionally to advance product development and testing.
- Conduct failure investigations/root cause analysis for issues identified by field support and summarize evaluations and results through written or oral presentations.
- Work cross-functionally to receive, prioritize, and implement design changes to improve quality and performance of DNA Script’s products in response to customer complaints and feedback
- BS or higher in engineering, chemistry, biochemistry, or related field
- Minimum of 5 years’ experience working in continuing engineering or new product development involving biotechnology instrumentation, operating under design controls (21 CFR 820.30)
- Experience creating and managing product requirement documentation & trace matrix
- Experience creating design and product specifications
- Experience troubleshooting/developing liquid handling automation systems, mechanical and electrical systems
- Strong documentation skills and ability to effectively communicate verbally and in writing, utilizing Word, PowerPoint and Excel
Ideal Candidate will have:
- Ability to organize and manage design documentation, respond to changes, and prioritize effectively
- Strong analytical mindset, detail oriented, and adept at communicating ideas, concepts, and presenting data
- Ability to solve complex problems and troubleshoot dynamic systems
- Versatile and adaptable to new methods, technologies and approaches
- Past experience developing systems for NGS / PCR applications is a plus
- Excellent communications skills
- Proactive, solutions-focused
- Phone interview with the hiring manager
- Day interview with manager, cofounders, HR and the rest of the team
- References check
- Timing: 2-3 weeks