Helix is a rapidly growing population genomics company working at the intersection of clinical care, research, and genomics. Founded in 2015 with a mission to “empower every person to improve their life through their DNA”, our end-to-end population genomics platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into routine clinical care. Powered by one of the world’s largest CLIA / CAP next-generation sequencing labs and our proprietary Exome+® assay, we support all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. We help our partners use genomics to improve health outcomes, increase patient engagement, lower costs, and drive cutting edge translational and clinical research. For the individual, we store and protect their DNA information so that they control their data and can use it throughout their lifetime in a variety of settings.
Leading health systems, including Renown Health, AdventHealth, and Mayo Clinic, use our population genomics platform to power some of the world’s largest and fastest-growing population genomics initiatives. We also collaborate with our health system partners to combine longitudinal EHR data with genomic data to optimize care across the health system. This proprietary clinico-genomic dataset, with recontactable individuals and actively enrolling programs, powers our life sciences segment and helps our life sciences partners bring innovative therapies to patients faster and more efficiently.
In response to the COVID-19 public health crisis, Helix is leveraging its expertise and infrastructure to develop and deploy more scalable and sensitive COVID-19 testing as well as accelerate research on the influence of genetics on COVID-19 infection and severity.
This role resides 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 the U.S. FDA (e.g. 21 CFR Part 820), and other applicable quality and regulatory standards (e.g. ISO 13485, ISO 14971).
As a Senior 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.
Continue to advance your career as you:
- Lead and participate in Risk Management (FMEA, Hazard Analysis), Design Verification, Design Reviews, and Cybersecurity activities.
- Develop risk management plans, requirement traceability matrices, and summary reports in collaboration with Bioinformatics team members.
- Be responsible for creation and maintenance of design history file documents.
- 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 the adequacy of verification or validation to support the change, good documentation practices, and compliance with procedures.
- Support internal and external audits and inspections.
We will be looking for you to have:
- Bachelor’s Degree in Biomedical, Chemical, or other relevant engineering discipline is required.
- 5 to 7 years of Quality Engineering experience.
- Minimum of three (3) years of experience in a design assurance role supporting medical devices that are FDA Class II or Class III.
- Working knowledge of FDA design control deliverables (21 CFR 820), IEC 62304, AAMI TIR45, ISO 14971, and Cybersecurity.
- Working knowledge of Agile Software Development methodologies and associated development tools (e.g. Jira, Jama).
- Familiarity with the role of Human Factors/Usability in the software development lifecycle.
- 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.
- Excellent interpersonal, verbal, and written communication skills.
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.