Responsibilities
- Lead execution of software-focused projects from initiation through delivery, including planning, timeline development, resource planning and coordination, risk management, and coordination of day-to-day activities
- Partner with a Product Owner/Manager to elicit, analyze, and document user and system requirements, partnering with laboratory operations, R&D, and other stakeholders to translate needs into clear, actionable specifications
- Hold cross-functional teams accountable to develop and maintain project and technical documentation, including requirements, user stories, workflows, and traceability artifacts in accordance with internal SOPs and regulatory standards
- Coordinate closely with software engineering, bioinformatics teams, and end user stakeholders to ensure requirements are understood, implemented correctly, and delivered on schedule
- Support development and deployment of LIMS and custom software tools, including enhancements, integrations, and new feature development
- Ensure compliance with applicable processes, including non-product software SOPs and, where applicable, product software development under IEC 62304 and design control frameworks, including documentation and traceability of requirements and deliverables
- Manage changes to software systems, including documenting updates, assessing impact, and supporting change control processes
- Track project progress and proactively identify risks, blockers, and dependencies, driving resolution to maintain timelines
- Facilitate cross-functional communication, ensuring alignment between technical and non-technical stakeholders
- Partner with software development and CLIA Laboratory stakeholders to plan and oversee testing and validation activities and management of user acceptance testing (UAT)
- Contribute to continuous improvement of software development and project management processes, tools, and documentation standards
- Adhere to formal governance processes to communicate project status, risks, and trade-offs; escalate issues as needed; and support the development of data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making
- Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution
- Cultivate, build and maintain positive and collaborative relationships with cross-functional teams
Requirements
- 2-4+ years of experience in technical project management, software project management, or equivalent combination of relevant functional experience in biotechnology, diagnostics, clinical laboratory, or life sciences industries
- Experience working on custom software development projects, preferably in life sciences, diagnostics, or regulated environments
- Strong experience gathering and documenting requirements
- Understanding of software project management methodologies (Agile, Scrum, or hybrid)
- Experience working in or exposure to regulated environments, including software documentation and traceability
- Strong organizational skills and attention to detail, with the ability to manage multiple tasks simultaneously
- Ability to work closely with engineers and translate between technical and business perspectives
- Proficiency with project management tools such as Jira, Confluence, Smartsheet, or similar
- Analytical mindset with strong attention to detail and ability to identify risks and dependencies
- Excellent communication skills, with the ability to tailor messaging across technical and non-technical audiences
- Situational awareness, coupled with facilitation, problem solving, and conflict resolution skills to drive cross-functional decision-making
Nice to Have
- Background in NGS diagnostics, including assay and software components (MRD experience preferred)
- Familiarity with laboratory software systems (strongly preferred)
- PMP, Agile Scrum, or equivalent certification is a plus
- Familiarity with IEC 62304 and/or software aspects of design controls (ISO 13485) (preferred)
Benefits
- Medical, dental, and vision
- Flexible PTO and paid holidays
- Parental leave
- 401(k) with company match
Work Arrangement
Hybrid
Team
Structure: high accountability, collaborative environment
Additional Information
- This position may be required to work across time zones as needed to support project schedules
- This role requires periodic onsite engagement to support cross-functional collaboration, program execution, and team alignment
- This position reports to the Associate Director, Program Management, with potential alignment under a Senior Program Manager as the team continues to scale
