Senior Risk Management Design Quality Engineer at Invitae (Formerly ArcherDx)

| Greater Boulder Area
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve! We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

Position summary:

As the Senior Risk Management Design Quality Engineer, you will support risk management across the product life cycle, leading safety risk management deliverables, collaborating with product development teams, manufacturing, post market monitoring, regulatory and clinical operations. You will be responsible for leading, authoring, organizing, and supporting risk management compliance to ensure goals and objectives are being met. This position will serve as an authority on Archer’s risk-based design lifecycle for software, system and assay. This position is expected to implement, collaborate, lead, interface and author risk management quality documentation.

Responsibilities:

Job performance will involve a variety of activities including:

  • As part of design & development, the person in this role will work with FTA, PHA, uFMEA, dFMEA, sFMEA, pFMEA and cybersecurity risk assessments. Risk management will also need to be performed for post market monitoring in support of complaint risk analysis, field corrective actions, design changes, maintenance efforts, non-product software risk assessments, supplier risk assessment evaluation and manufacturing non-conforming materials.
  • Longer term improvement opportunities for the organization will be to centralize and improve the risk analysis documentation and completion efficiency such as selecting, deploying and configuring risk management tools.
  • Leading and applying a consistent approach to hazardous situations, harm identification and risk estimation to ensure uniformity within each project life cycle. These may entail working with clinical professionals, external business partners, and chief medical officers.
  • Daily tasks will be based around risk management documentation, risk analysis, failure mode effects and analysis, authoring risk controls and traceability mapping for identified risk controls including their verification of effectiveness, risk based V&V methods and post market software maintenance, residual risk review and risk benefit analysis. Product DHF risk management files shall be organized in order to support successful regulatory submission while working with the regulatory teams for FDA and EU submission.
  • Partner with other functions in the organization to ensure partners requirements are addressed, provide consistent communication with multi-functional teams and encourage a spirit of risk management collaboration throughout the organization. Applies flexible and novel approach to solve problems or optimize solutions in sophisticated or multi-functional product development and manufacturing.
  • Review, understanding, and compliance with Invitae HIPAA Security policies and procedures.
  • Processing and handling of European Union personal data only as directed by Invitae for purposes of personalized molecular pathology.
Experience:
  • Minimum of 5 years in supporting risk management used in a regulated industry with desired experience in performing software risk assessment. Good technical writing skills with hands-on experience authoring, peer-reviewing and defending documentation.
  • Minimum B.A. or B.S., preferably in engineering or other technical subject area
  • Certifications, such as ASQ, in quality assurance preferred.
  • Ability to interact with multiple fields and communicate clearly and effectively verbally and in writing.
  • Ability to work independently and utilize good problem-solving skills.
  • Design quality risk management authority in the implementation and compliance with 21 CFR 820.30 ISO 14971, ISO 13485.
  • Desired experience and knowledge with IEC 62304, MDR, IVDR, TIR57, FDA cybersecurity guidance, HIPAA, GDPR.

In Colorado, our competitive compensation package includes a base salary starting Fromm $118,800.In determining the final salary offered we will evaluate a specific candidate geographic location, education, skills and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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Technology we use

  • Engineering
    • C++Languages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • RubyLanguages
    • SqlLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • ReactLibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • MongoDBDatabases
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of Invitae (Formerly ArcherDx)

What’s the vibe like in the office?

Collaborative - when I walk through the Invitae office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Invitae. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

What are Invitae (Formerly ArcherDx) Perks + Benefits

Invitae (Formerly ArcherDx) Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Volunteer in local community
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Restricted work hours
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Happy Hours
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
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