Technical Project Manager / Business Analyst Medical Device Software

Position:

Technical Project Manager / Business Analyst -

Medical Device Software Status:

Full-Time; W-2 (Applicants must be authorized to work in the United States without current or future sponsorship.)

Shift:

Days; Position is hybrid and does have some in-office requirements Reports to: CIO Company Overview Precision Monitoring is a leading innovator in healthcare diagnostics, offering remote monitoring and enterprise management solutions that drive better outcomes across the healthcare continuum. We specialize in Holter, Event, and Telemetry monitoring systems that simplify complex workflows for providers operating in a highly regulated environment. Our culture promotes analytical thinking, innovation, and a commitment to excellence. As we continue to expand, we're seeking passionate professionals who bring energy, integrity, and a results-driven mindset to join our growing team. We offer competitive compensation, comprehensive medical benefits, and a collaborative work environment. Position Summary The Technical Project Manager / Business Analyst - Medical Device Software serves as a senior delivery and requirements leader responsible for planning, executing, and validating software and technology initiatives within a regulated healthcare environment while ensuring predictable, on-time delivery of business-critical solutions. This role combines project management, business analysis, and validation oversight to ensure solutions are delivered in compliance with business, clinical, quality, and regulatory requirements. The ideal candidate has experience supporting healthcare software or medical device development, understands verification and validation principles, and can independently translate complex business needs into traceable, testable, and auditable requirements.

Key Responsibilities:

• Lead end-to-end delivery for technology and business initiatives from intake through release and stabilization, using Agile and hybrid delivery approaches.
• Establish and maintain delivery plans, sprint/release schedules, milestones, and status reporting aligned to scope, timeline, and business outcomes.
• Facilitate team ceremonies and working sessions (planning, standups, backlog refinement, reviews, retrospectives, stakeholder workshops) to ensure consistent cadence and transparency.
• Elicit, analyze, and document requirements using interviews, workshops, observation, and data/process analysis; translate needs into clear user stories, acceptance criteria, and supporting documentation.
• Own and maintain backlog readiness, model current- and future-state processes, identify gaps, and recommend solution options that improve efficiency, controls, and user experience.
• Manage scope, risks, assumptions, issues, and dependencies; coordinate cross-team and vendor activities to ensure integrations, cutovers, and releases are planned, tested, and communicated.
• Drive release readiness, change management, and adoption activities including communications, training coordination, and release notes; continuously improve team ways of working through retrospective action plans. Verification, Validation & Traceability
• Support software verification and validation activities by ensuring requirements are traceable, testable, and supported by appropriate evidence.
• Review validation, equivalence, and testing documentation to identify gaps, risks, inconsistencies, or unsupported conclusions.
• Partner with Quality, Product, Engineering, and Operations teams to ensure release readiness and regulatory compliance.
• Maintain end-to-end traceability between business requirements, functional requirements, testing, and deployment outcomes.
• Participate in change impact assessments and ensure validation activities remain aligned with evolving requirements.

Essential Functions:

• Support and coordinate verification, validation, UAT, and release readiness activities; ensure requirements are fully validated, defects are appropriately triaged, and testing evidence supports intended use.
• Evaluate requirement changes and determine impacts to testing, validation, documentation, and release timelines.
• Track and communicate progress, impediments, and delivery metrics (e.g., throughput, cycle time, burnup/burndown) to stakeholders with clear trade-offs and recommendations.
• Partner with business and technical stakeholders to define goals, scope, success measures, and delivery approach; drive decision-making and manage expectations.
• Generate weekly and monthly performance reports and maintain status reporting aligned to delivery goals.
• Maintain confidentiality and uphold professional standards across all project and analysis activities.
• Perform other duties as assigned to support department and company objectives. Qualifications
• 5+ years of Project Management experience leading software delivery initiatives (Agile, hybrid, and/or waterfall) with accountability for delivery outcomes.
• Experience working within healthcare, healthcare technology, medical device, SaaS healthcare, or other regulated environments
• 3+ years of experience performing business analysis activities including requirements elicitation, documentation, and stakeholder facilitation.
• 3+ years of experience in a custom application development environment where internal technical resources are accountable for all facets of build, delivery, and support.
• Experience supporting verification, validation, UAT, testing, or release readiness activities
• Experience working directly with software development teams responsible for custom application development.
• Hands-on experience facilitating Agile delivery practices with Scrum and/or Kanban teams (planning, standups, refinement, reviews, retrospectives).
• Demonstrated ability to manage scope, schedule, risks, issues, and dependencies across multiple stakeholders; budget management experience a plus.
• Experience translating business needs into clear deliverables (user stories, use cases, process flows, and/or functional specifications) with measurable acceptance criteria.
• Proficiency with common delivery and analysis tools such as Jira, Azure DevOps, Confluence, Smartsheet/MS Project, Visio/Lucidchart, and Excel. Highly Preferred Experience
• Experience with FDA-regulated healthcare software, Software as a Medical Device (SaMD), Class II medical devices, or similarly regulated healthcare technologies.
• Familiarity with Design Controls, Risk Management, Verification & Validation, Change Control, and Traceability practices.
• Experience reviewing validation reports, equivalence documentation, and release readiness assessments.
• Experience partnering with Quality, Regulatory, Clinical, or Product teams. Preferred Qualifications
• Relevant certification(s) preferred — such as PMP, PMI-ACP, CSM/PSM, SAFe, CBAP/ECBA, PMI-PBA, or CSPO.
• Experience delivering enterprise applications, systems integrations, or data/analytics initiatives preferred.
• Strong analytical, problem-solving, and communication skills; able to translate complex topics for both technical and non-technical audiences.
• Demonstrated accountability and ownership of outcomes with a commitment to upholding professional standards.

Equal Opportunity Statement Precision Monitoring is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and do not discriminate based on race, color, religion, gender, national origin, age, disability, genetics, veteran status, sexual orientation, or any other protected characteristic under applicable law. This policy applies to all employment practices including hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Pay:

$130,000.00 - $160,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Health savings account Vision insurance

Work Location:

Hybrid remote in Burleson, TX 76028