As a leader in our Software Engineering Technical Product Management team, the Manager, Laboratory Informatics will manage a team of Laboratory Informatics Specialists (LIS) who contribute through multiple functions including requirements gathering, configuration development, testing, and support of LabVantage LIMS modules such as reagent management, equipment management, storage, biobanking, and other features.
Laboratory Informatics Specialists work closely with multiple groups to implement and support LabVantage LIMS systems for supporting the organization’s laboratory management activities. This includes understanding the business processes of the groups we work with and applying technical expertise to assist in the software development and support processes
- Manage a group of directly reporting Laboratory Informatics Specialists including hiring, developing reports, and allocating work within the team
- Own the LIS backlog and oversee project management of all LIS projects
- Align with business leadership on upcoming priorities for the team, and manage the LIS team’s development roadmap in Jira
- Understand LabVantage capabilities and pursue opportunities to leverage them for unmet needs throughout the business
- Represent Software Engineering as a leader in meetings and other communications with cross-functional teams
- Act as a subject matter expert on LabVantage to provide guidance to stakeholders and create a shared understanding among business and technical teams
- Propose, implement, and drive adoption of improved practices, processes, and tools within LIS and Engineering
- Configure LabVantage to implement features and changes for maintenance releases and new product development.
- Translate laboratory needs into clearly written technical product requirements and specifications.
- Produce deliverables that facilitate better understanding for feedback such as flow diagrams, data models, pros/cons, prototypes, wireframes and other illustrations.
- Complete software quality assurance including documentation of test cases and execution of testing for changes implemented by other LIS team members.
- Assist engineering production support with resolving LabVantage issues and investigations.
- Assist in assembly of reports needed for regulatory compliance requirements including FDA 21 CFR Part 11, GCP, CAP / CLIA, HIPAA, CE mark, GDPR, IVDR, etc.
- Will manage a staff having hiring and firing responsibility.
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
- Employee must pass post offer criminal background check
- BS in related major or equivalent industry experience.
- Minimum of 8 years of relevant experience, which includes 5+ years of direct experience working in software application development.
- Experience managing employees. Role accomplishes tasks through direct supervision of employees.
- Experience working with users to configure data management software to meet business workflow requirements.
- Experience in creating commercial software product requirements and managing a product backlog
- Experience working with relational databases and creating SQL queries (especially Oracle).
KNOWLEDGE, SKILLS, AND ABILITIES
- Skills in assessing and developing software product management, development, and quality assurance skills in team members
- Confidence in addressing escalations of issues and decisiveness in implementing resolutions
- Ability to understand and track the work of a team while completing own deliverables in parallel
- Knowledge in following areas of software development:
- Software product requirements documentation
- Data management software configuration/administration
- Software QA testing and documentation
- JIRA or similar issue tracking system
- Required domain knowledge:
- LIMS, LIS, LES, and/or ELN (especially LabVantage)
- Laboratory processes and instrumentation
- Compliance requirements for a medical device or IVD company
- Required technical skills:
- DB design understanding and SQL skills
- Comfortable with Linux command line usage
- Cloud/AWS basics
- Comfortable contributing to and leading meetings with business partners in variety of positions and domain areas to receive product requests and guide decision-making
- Ability to understand and describe technical complexities in a simplified way appropriate to different audiences
- Excellent written communication skills to produce clear, concise and correct technical documentation
- Strong ability to comprehend complex problems and apply knowledge to propose potential solutions
- Analytical skills to be able to understand the needs of customers and work out priorities.
- Be able to break down large projects into granular milestones and track progress.