Program Manager, Informatics R&D

Alphatec Spine•Carlsbad, CA

12h•$117,000 - $125,000

About The Position

We are seeking an experienced Program Manager to support execution of cross-functional Informatics R&D programs involving software-intensive medical products, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) deployed on electro-mechanical systems or cloud platforms. This role is responsible for driving disciplined execution within defined program or project scope, ensuring that work is planned, tracked, and delivered with clarity and accountability in a regulated medical device environment. The Program Manager coordinates cross-functional teams, maintains visibility into execution status, and ensures that deliverables, risks, decisions, and action items are actively managed. To be successful the ideal candidate would be organized, collaborative, detail-oriented, and able to keep cross-functional teams aligned on priorities, commitments, execution risks, and next steps.

Requirements

Experience supporting or leading cross-functional project or program teams through product development, release planning, execution, and delivery in an R&D, engineering, technology, or product development environment.
Experience managing schedules, milestones, dependencies, risks, decisions, action items, and deliverables across multiple functions.
Experience working in a structured or regulated product development environment with formal planning, documentation, change control, decision tracking, and cross-functional coordination.
Experience supporting software-intensive products; experience with medical device software, SaMD, SiMD, embedded software, cloud-connected platforms, data platforms, imaging systems, AI/ML-enabled products, or other regulated software products is preferred.
Familiarity with medical device quality and regulatory frameworks such as ISO 13485, FDA design controls, IEC 62304, ISO 14971, cybersecurity/security risk management, or related standards and processes is preferred.
Experience with Agile, hybrid Agile/waterfall, phase-gate, design-control-based, or other structured development models.
Experience with modern project planning, development support, and collaboration tools such as Smartsheet, Jira, Jira Product Discovery, Confluence, Microsoft Project, Azure DevOps, or similar systems.
Demonstrated ability to coordinate cross-functional work, build alignment, follow up on commitments, and escalate issues appropriately.
Strong written and verbal communication skills, including the ability to prepare clear status updates, meeting summaries, action logs, and decision records.
Strong organizational and problem-solving skills, with the ability to turn plans, risks, and open issues into actionable follow-up.
Ability to manage multiple priorities in a fast-paced environment with changing business, technical, and resource constraints.
Bachelor’s degree in Engineering, Computer Science, Systems Engineering, Biomedical Engineering, Life Sciences, Business, or a related discipline with 5 years of experience required.
Prior experience in project management, program management, technical program management, product development, systems engineering, or a related role supporting complex product development required.

Nice To Haves

PMP, Agile, Scrum, Lean, Six Sigma, or similar project/program management certification preferred.

Responsibilities

Manage defined Informatics R&D projects or programs involving software, systems engineering, data platforms, cloud technologies, medical device software, and related informatics capabilities.
Build and maintain project or program plans covering scope, milestones, schedules, dependencies, deliverables, risks, decisions, and action items.
Coordinate program execution through regular status reporting, meeting cadence, action tracking, decision tracking, risk tracking, and issue escalation.
Coordinate cross-functional deliverables across software engineering, systems engineering, data and informatics, product management, regulatory, quality, verification and validation, clinical, operations, and other stakeholder groups.
Lead core team meetings and planning discussions, ensuring actions, owners, decisions, risks, and open issues are documented and followed through to closure.
Support programs involving SaMD and SiMD products deployed on electro-mechanical systems or cloud platforms, ensuring execution follows applicable design controls, quality system expectations, regulatory plans, and controlled documentation processes.
Partner with Systems Engineering, Regulatory Affairs, and Quality to coordinate development, verification, validation, risk management, and regulatory deliverables.
Track scope, schedule, risks, dependencies, and tradeoffs within assigned projects or programs.
Support roadmap, release, and portfolio planning activities by providing accurate project status, schedule, risk, and dependency information.
Use modern project planning, development support, and collaboration tools to create visibility, manage execution, track dependencies, and support decision-making.
Communicate project or program status, risks, issues, and recommendations clearly to core teams, functional managers, and program leadership.