POSITION SUMMARY:
The Senior Laboratory Informatics Specialist is part of our Technical Product Management team within the Software Engineering department. Laboratory Informatics Specialists work closely with multiple groups to implement and support LabVantage LIMS systems for tracking the organization’s laboratory workflows. 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. This role will perform the delivery of requirements, testing, and use of LabVantage for configuration and support.
PRIMARY RESPONSIBILITIES:
- 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.
- Act as a subject matter expert on LabVantage to provide guidance to stakeholders and create a shared understanding among business and technical teams.
- Produce deliverables that facilitate better understanding for feedback such as flow diagrams, data models, pros/cons, prototypes, wireframes and other illustrations.
- Build confidence with our business partners by adding value to discussions, being responsive, and following through on action items.
- Maintain tracking of requests from user groups and prioritize those for time allotment and release planning.
- Assist software quality assurance with testing of changes in LabVantage.
- 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.
- Suggest and drive introduction of departmental practice changes and tools that will improve quality and organization of LabVantage engineering work.
- Oversee work and delegate tasks to other engineering team members when needed Act as a mentor and help to develop more junior Laboratory Informatics Specialist team members
- 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
QUALIFICATIONS:
- Minimum of 8 years of relevant experience, which includes 5+ years of direct experience working in software application development.
- 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:
- 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:
- Comfortable with Linux command line usage
- Some programming or scripting knowledge (Java, Groovy, JavaScript) 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.
