Company Overview
Auxogyn is a privately held company and leader in reproductive health. We provide novel scientific and clinically validated solutions to IVF clinicians and their patients by translating scientific discoveries in early embryo development into clinical tools that improve patient outcome. The company’s flagship product, the Eeva Test, delivers objective information regarding embryo development that IVF clinicians and patients can use to make important treatment decisions.
Auxogyn’s Eeva System is the first and only non-invasive device FDA has cleared to date to aid in embryo selection. Auxogyn received FDA clearance for the Eeva System in June, 2014. The Eeva System also received the CE mark in July 2012, and it is currently available for use in selected countries in the EU and Canada.
Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech. Follow the company on Twitter @Auxogyn.
Position Summary
Responsible for ensuring software quality for medical device products through participating in the development and execution of software test plans by way of verification procedures based upon software and system specifications. Plan, provide guidance and assist in system, regression and acceptance testing for safety, new features, and compatibility with other software components. Support quality assurance functions, including, but not limited to, complaint investigation, CAPA, software quality assessment, software risk/hazard analysis. Ensure deployment of a best in class software development, verification and validation environment.
Major Duties and Responsibilities
- For Design Assurance:
- Provide expertise and guidance in interpreting regulations to ensure compliance. Establish methods for monitoring the compliance of software system processes, standards and procedures, including IEC 62304 and FDA guidance.
- Partner with internal colleagues to influence or plan and execute strategies for continuous improvement in processes, standards and procedures that accommodate software quality, systems and/or compliance needs
- Proactively identify problems, drive to root cause and develop preventative problem solving solutions
- Review and challenge software documentation (including requirements, design, verification, validation, test procedures) to ensure that requirements stated are correct, unambiguous, and verifiable
- Consult with product development to evaluate system interfaces, operational requirements, and performance requirements of overall system
- For Software Test Engineering / Verification and Validation:
- In collaboration with the R&D software team, create, conduct and lead a manual and automated software test program in direct support of software product development for a Class II medical device. The program will consist of supporting software development initial test and debugging effort leading up to a comprehensive and complete Verification and Validation program in support of regulatory submissions and product release.
- Provide guidance to the Software Test Team
- Acts as lead project team member who provides independent review on deliverables used to develop, implement and maintain clinical/manufacturing/device/Quality software.
- Lead the software risk management process throughout entire product lifecycle
- QA representative on software code reviews
- Active collaborator with the software team on finding, logging and tracking software issues through to closure
- Support the Software testing group on initial software test and debug eventually leading up to Software Verification and Validation
- Responsible for conducting or QA approving software Complaint Investigations
- Provide quality assurance support to software related CAPAs and Non conformities
- Provide quality engineering interface between Quality and R&D Software teams
Preferred Qualifications
Education and/or Job Experience
- BS of Science Degree in Computer Science or related field
- 7 – 10 years hands on experience in software quality assurance associated with time embedded software systems in regulated industry
- Medical Device or Regulated Industry Software Development experience a must
- Experience Leading SQA Teams in a regulated software development environment
- Experience supporting software development project teams in a regulated environment
- Experience conducting and leading Software V&V in a regulated environment
- Experience with Software Design Control Elements in a regulated environment
- Experience with Software Requirement and Defect Tracking Systems a must
- Experience with Software Test Automation a must
Special Skills, Abilities, and Requirements
- Must have strong analytical, statistical, problem solving, communication, and interpersonal skills
- Effective root-cause defect analysis skills
- Detail oriented with excellent team oriented organizational skills
- Prior software quality assurance experience in a product development environment in the medical device industry
- Working knowledge in software standards and regulations i.e. IEC 62304, IEC 62366, ISO 14971 & FDA related guidance
- Strong knowledge of CFR820, Part 11, ISO 13485, ISO 14971, IEC 60601
- Expert with concepts of design input, design output, traceability, and software verification and validation
- Knowledge of C++ and C# programming languages strongly preferred
- Experience with Windows Operating Systems
- Strong skills in test plan development & execution, problem isolation, writing clear & complete defect reports
- Experience with writing and executing various testing strategies (white box, black box, ad hoc, stress, etc) to help ensure high quality test output.
- Experience with Agile Development Methodologies in a regulated environment a strong plus.
- Experience with the application of risk management tools
- Understanding of software configuration management principles
- Must be able to work with minimal supervision
- Experience with class II medical devices. Experience with Software Design, Software Debugging, Software Documentation, Software Functional, Unit and Automated Testing, Software Development Fundamentals, Software Development Process, Software Requirements
Demonstrated Personal Characteristics
Candidate must be driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others. Essential attributes of the successful candidate is one who:
- Is Action Oriented:
- Motivated by results
- Full of energy when faced with challenges
- Able to make and implement tough decisions
- “Proactive” as opposed to “reactive”
- Deals with Ambiguity:
- Can be flexible and adaptable in a complex, changing environment
- Can comfortably handle risk and uncertainty
- Works Collaboratively:
- Practices attentive and active listening
- Has the patience to hear people out and to search for constructive input
- Exemplifies Interpersonal Savvy and Integrity:
- Relates well to all kinds of people—both inside and outside the company
- Builds constructive and effective relationships
- Uses diplomacy and tact
- Adheres to an appropriate set of core values and beliefs
- Always acts with uncompromising integrity
- Is Respected as a Leader:
- Leads and influences constituents with possible divergent interests to complete a common goal
- Is recognized within the Quality/Software Engineering community or related industry peers
We offer a competitive compensation package including health insurance, stock options and a challenging work environment. We are an equal opportunity employer.
Qualified candidates please send your resume to [email protected].