Senior Bioinformatics Quality Engineer I
Exact Sciences Corporation
- San Diego, CA
- $119,000-190,000 per year
- Permanent
- Full-time
- Be accountable for design controls for medical device software and best practices for LDT software and create and manage all applicable documentation.
- Participate in creation and management of software requirements.
- Participate in design feasibility assessments of medical device software.
- Participate in risk assessments and hazard analysis for software products, including identification of potential risk mitigations and traceability to software requirements.
- Work closely with Regulatory and Quality to provide the appropriate level of software documentation, compatible with regulatory requirements.
- Aid testers in the translation of user and software requirements into executable software verification and validation protocols.
- Mentor team members with a focus on software quality processes for regulated medical devices.
- Communicate documentation requirements to stakeholders across the organization.
- Institutionalize development best practices and evangelize test-driven development in the bioinformatics engineering team.
- Take part in audits, representing software activities and answering queries.
- Work on problems of extremely complex scope in which analysis of data requires an evaluation of intangible variables.
- Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining solutions.
- Work on assignments individually and with project team members to meet department and project objectives.
- Work within project timeframes with successful outcomes on multiple projects and key responsibilities.
- Exercise excellent team-working skills with ability to complete collaborative projects on time and within budget.
- Exercise excellent verbal and written communication skills with the ability to communicate complicated ideas and information effectively at all levels.
- Work towards challenging goals in a fast-moving environment where on-time delivery of results is a high priority.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability and means to travel 10% between local Exact Sciences locations.
- Ability to travel 5% of working time away from work location, may include overnight/weekend/international travel.
- B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties.
- 4+ years of experience spanning software quality engineering and medical device systems engineering and bioinformatics.
- Demonstrated deep understanding of and competence in the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
- Knowledge of production software development lifecycle.
- Proven capabilities in creating verification and validation documentation, including GxP Assessments, Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.
- Understanding of best practices for software development (such as Git, agile, code reviews, CI/CD).
- Ability to effectively communicate software system designs.
- Experience working within a Quality Management System.
- Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Master’s or Ph.D. degree is preferred.
- Familiar with software testing in the context of medical devices software such as bioinformatics analysis pipelines.
- Experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software.
- Experience with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc. Work experience is strongly preferred.
- Familiarity with bioinformatics analysis pipeline frameworks.
- Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc.
- Experience with PAI, ISO and MDSAP audits is a plus.
- Experience managing requirements in a validated RM tool such as JAMA, DOORS, etc.