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.
The Systems Engineer will serve as a subject matter expert on Invitae’s design control project core teams. This position is expected to help translate Invitae’s vision for IVD products into high quality, safe, effective and cost effective products while maintaining a high degree of compliance with world wide safety, cybersecurity, data privacy regulations. The Systems Engineer will develop requirements from user needs and intended use and allocate them to other teams. They will define the overall verification and validation plans in coordination with cross functional teams. They will develop processes, author quality documentation, and disseminate expertise via training, mentoring and core team collaboration.
- Responsible for system level design elements across a product, specifically marrying assay and software elements of a platform. Includes:
- System design and requirements definition in consideration of the technical, operational, and commercial constraints
- Risk Management
- System-Level Validation
- Facilitate project team in identifying impacts to design, risk, and process when change is required
- Act as a facilitator of risk management (ISO14971:2012) as it applies to the creation of a risk management file for the product under development. Utilizing the results of the risk assessment as inputs into the design verification protocols, design validation protocols, supplier stratification and process validations.
- Support core teams in the planning, verification & validation, transfer and product launch.
- Support as an SME for the Design History File during internal and external audits.
- Where appropriate, manage external resources, such as consultants, on key initiatives by demonstrating accountability to management on timelines, costs and execution.
- Assess project and infrastructure needs to create and execute and organizational plan to ensure proper support for all of Archer’s product and infrastructure obligations.
- Support diligence audits, as a subject matter expert, by pharmaceutical partners (potential and current) as well as quality and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues in a timely manner.
- Perform other duties as assigned by supervisor
- Follow company policies for producing CDx/IVD software in the planning and development stages of a regulatory submission
- Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures
- Safeguarding the privacy and security of protected health information and European Union personal data
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology
- 5+ years in Product Development/Quality/Engineering with 2+ years in the design or development of regulated class II and/or class III IVD/medical devices.
- Preferred companion diagnostic design control experience for demonstrable experience in medical device risk management, process validation, supplier development.
- Preferred familiarity with systems engineering, especially in complex multi discipline systems.
- Preferred Technical knowledge/familiarity -in NGS chemistry, NGS bioinformatics, Software Development, Cybersecurity
- Preferred experience with requirements analysis, use case analysis.
- Nice to have: familiarity with human factors engineering, configuration management.
- Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in
- Ability to work independently and utilize good problem-solving skills.
- Ability to multitask and work within a fast-paced dynamic team environment. Archer is interested in a
- subject matter expert who will build collaboration among key departments rather than define functional boundaries.
- BS/MS/PhD preferred with relevant training in Engineering, Chemistry, Manufacturing, and/or Biological Sciences or equivalent experience.
- Insatiable curiosity
- Introspective and self-aware
- Healthy dose of insecurity that leads to data driven decisions
- Relies on data more than gut instinct
- Puts the team harmony over their own self-interest
- Disciplined to follow process
- Proven managerial skills to bring teams together to achieve common goals
- Strong communication and presentation skills
- Proven ability to thrive in a change-oriented environment
- Self Starter
- Self-directed: needs little explicit direction and no hand-holding
- Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
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.