Design Quality Engineer
We believe that everyone benefits from their biological information. It is our mission to empower every person to improve their life through DNA. With our high-quality, trusted partners and state-of-the-art lab, we have created the first platform of personalized products and services powered by genetics. From inherited cancer screening to custom fitness and nutrition plans, the world of DNA learning is becoming more accessible and more valuable than ever.
So far we have raised over $300 million from investors like Illumina (the world’s leader in genetic sequencing equipment), Warburg Pincus, Sutter Hill Ventures, Kleiner Perkins Caufield & Byers and Draper Fisher Jurvetson Growth. Our app store and marketplace include partners such as National Geographic, Admera Health, Vinome and many others, with whom we have partnered to develop applications which interpret your genome.
Our big vision comes with big responsibility. That’s why we’re building a team of experts in the field of genetics, engineering, design, business development, and beyond to help bring actionable insights to our customers. We’re looking for the best and brightest minds who are passionate about our mission and are excited to work with a truly diverse team.
This role sits on the Quality Assurance team and will be responsible for the development, implementation, and maintenance of QMS Design Control processes to meet the requirements of U.S. FDA (e.g. 21 CFR Part 820), and other applicable quality and regulatory standards (e.g. ISO 13485, ISO 14971).
As a Design Quality Engineer, you would have an integral role in implementing software medical device lifecycle processes and work closely with the Bioinformatics team to support regulatory submissions and compliance activities. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment. If you are looking for the opportunity to lead and make a significant contribution, this role provides an empowering and action-oriented environment to take your career and our mission to the next level.
As a Design Quality Engineer, you will:
- Be responsible for creation and maintenance of design history file documents.
- Develop risk management plans, verification/validation plans, requirement traceability matrices, and summary reports in collaboration with Bioinformatics team members.
- Contribute to the design and process Failure Mode Effects Analysis and System Hazard Analysis activities.
- Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Provide direction on CAPA activities including scope and implementation plans.
- Support change control process through the creation of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance with procedures.
- Support internal and external audits and inspections.
- Bachelor’s Degree in engineering, science or related field required.
- 4 to 7 years of Quality Engineering experience.
- Minimum of two (2) years of experience in a design assurance role supporting medical devices that are FDA Class II or Class III.
- Working knowledge of FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.
- Working knowledge of Agile Software Development methodologies and associated development tools (Jira, Jama,) is highly desirable.
- Track record of creating design history file documents.
- ASQ (e.g. CQE, CRE, or CSQE) certifications or other software quality certificates are desirable.
- Experience with supporting regulatory audits and FDA inspections is a plus.
An Ideal candidate will have:
- Attention to detail, strong organization skills, and ability to work independently and in teams.
- Excellent interpersonal, verbal and written communication skills.
- Ability to deliver quality outputs under minimal supervision.
- Working knowledge of software configuration management.
What Helix has to offer you
Aside from working alongside brilliant, dedicated, passionate, down-to-earth, curious, warm, and thoughtful people, we also provide great benefits:
- Competitive compensation, including meaningful equity
- Health insurance, including medical, dental, and vision
- 12 weeks of Maternity or Paternity leave
- 4 weeks of paid Pregnancy Disability
- 401(k) with employer matching
- On-premise nursing room
- Corporate fitness rate
- Commuter benefits
- Catered meals
- Flexible PTO
Helix is proud to be an equal opportunity employer, and committed to providing employment opportunities regardless of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, pregnancy, childbirth and breastfeeding, age, sexual orientation, military or veteran status, or any other protected classification, in accordance with applicable federal, state, and local laws.