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