Staff Quality Engineer, Helix
$128-194k
Expected Helix Discretionary Annual Bonus: 15% of your annual salary. Plus equity
Office located in San Mateo, CA
Population genomics and viral surveillance company
Job no longer available
Population genomics and viral surveillance company
501-1000 employees
Job no longer available
$128-194k
Expected Helix Discretionary Annual Bonus: 15% of your annual salary. Plus equity
Office located in San Mateo, CA
501-1000 employees
Company mission
To empower every person to improve their life through their DNA.
Role
Who you are
- Bachelor’s Degree in Engineering, Science or related discipline required
- Minimum of 8 years of Quality Engineering experience working directly with software development teams in a regulated environment (FDA and/or CLIA/CAP)
- Strong verbal and written communication with ability to effectively present at multiple levels in the organization
- Proficient in Quality System Regulations (e.g. 21 CFR 820, IEC 62304, ISO 14971 and CAPA processes)
- Working knowledge of Agile Software Development methodologies and associated development tools (e.g. Jira, Jama)
- Physical/Mental Demands: This role requires prolonged periods of sitting while being able to view and read text on computer screens less than a few feet away
- May periodically require lifting up to 10 pounds and occasional walking or standing
- May require repetitive motions that may include the wrists, hands, or fingers. May require meetings in person or via video conference (on or off-camera)
- Requires work in a typical office setting or may be eligible for remote work
- Role also requires the ability to reason logically and make sound decisions; ability to understand, remember, and follow verbal and written instructions; and ability to perform in situations requiring deadlines
- Ability to work as an integral part of a team
What the job involves
- The Staff Quality Engineer role will be responsible for leading software compliance activities for the Enterprise and Experience development teams
- Specifically, this role will partner with Engineering and Product teams to establish and maintain development lifecycle processes to meet customer and regulatory requirements
- Lead quality activities for software product development from requirements, risk management and test verification
- Responsible for developing and maintaining processes and procedures, and ensuring adherence to the software development lifecycle
- Coach and mentor team members on regulatory practices in verification testing and product lifecycle
- Review and approve verification protocols and test results to ensure software meets customer and regulatory requirements
- Facilitate risk management activities from product concept to commercialization
- Provide direction on CAPA activities, including scope and remediation plans
- Support change control process through creation of documentation, ensuring adequacy of verification or validation to support the change, and compliance to procedures
- Participate in the design and development process, working closely with Engineers, Product Managers, and Compliance team members
- What To Expect During Your First 90 days:
- First 30 days: you’ll spend time learning the Helix way, completing training and onboarding for your roles, and getting introduced to your team and relevant stakeholders. You’ll also gain a deeper understanding of our customers, our products, the impact we make in the lives of our communities, and how to thrive at Helix through participation in Helix U
- Day 30 - 60: you’ll spend time contributing to projects, deeply familiarizing yourself with team and company processes, and developing a deeper understanding of Helix’s products, services and capabilities
- Day 60 - 90: you’ll build your OKRs with your manager, start to take ownership of projects and initiatives on your team, and begin to demonstrate your impact on the Helix mission
Application process
- Recruiter Screen
- Manager Screen/Tech Screen
- Onsite
- Offer
- What To Expect During Your Onboarding Week:
- We want to make sure your first week is spent learning the foundations. You will be invited to live orientation sessions and spend time with your hiring manager developing your individual roadmap to success
- This experience will include sessions that cover your benefits, security & privacy training, an introduction to the OKR framework used at Helix and our communication tools and norms
Our take
Helix is a population genomics company working at the intersection of clinical care, research, and genomics. The end-to-end platform produced by Helix enables healthcare systems to achieve better outcomes, while also providing valuable information for life science companies. Understanding genetics is a valuable tool for businesses as they can deliver products and services that are designed specifically for the individual DNA of consumers, drastically increasing their safety and effectiveness.
The Helix platform delivers some incredibly complex clinical research data, which makes it possible for a variety of businesses to gain genetic insight. The company also stores data in large quantities, making it flexible and readily accessible for its clients.
Many companies are working in the space such as 23andMe, MyHeritage, Orig3n and Ancestry. They are all fighting for a share of the genetics market, predicted to be worth $55 billion by 2025.
Freddie
Company Specialist at Welcome to the Jungle
Insights
14% employee growth in 12 months
Company
Funding (last 2 of 6 rounds)
Jun 2021
$50m
SERIES C
Jul 2020
$33m
GRANT
Total funding: $411m
Company benefits
- Flexible Time Away
- 401K
- Health Benefits
- Commuter Benefits
- Paid Parental Leave
- Wellness Program
Company HQ
Downtown, San Mateo, CA
Leadership
James Lu
(CEO & Co-Founder)MD/PhD from Baylor College of Medicine. Senior Engineer at Merck, Research Fellow at Wellcome Trust. Co-founded Helix in 2015.
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