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:
We are looking for a Quality Assurance Design Control Engineer. This person will have overall responsibility for leading design controls and risk management activities within Genpsys. In this hands-on role, this person will work with the product development, operations, support and marketing teams.
- Create and implement Design Control procedures and templates.
- Review and Approve Design Control documentation.
- Provide QA support for Assay Product development from feasibility through Commercialization phase.
- Provide QA support for Software Product Development.
- Work closely with product development and Operations to ensure product is transferred properly.
- Drive Risk Management activities based on ISO 14971 and ensure compliance to standards and regulations
- Lead Risk Management activities such as FMEAs, Hazard Analysis and other risk assessment processes and documentation (as required).
- Ensure design control documentation and requirements are met.
- Create and maintain Design History File (DHF).
- Provide coaching to key personnel on Design Control requirements.
- Minimum of a Bachelor of Science Degree in Engineering or scientific field with at least 5 years in the medical device or combination products industry.
- Must have Assay and Software product experience.
- Expert knowledge and understanding of design, development, verification and validation processes.
- Working knowledge and understanding of Medical Device regulations and standards such as 21CFR 820, ISO 13485 and Risk Management (ISO 14971).
- Excellent verbal, written, communication and proficient computer skills.
Bonus points if:
- Are adaptable to fast-paced, dynamic work environments and shifting demands.
- Are highly collaborative, team-oriented, and an effective communicator
- Are scrappy, willing to pitch in where needed.
- Have a passion for making a difference in the world
- Have the ability to work effectively in a matrix organization.
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.
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!