Manager Medical Device Software Engineer Jobs in Temecula, CA

We are seeking an experienced Senior Program Manager to lead complex, 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 owns end-to-end program outcomes across multiple related programs, releases, product lines, or platform capabilities, driving execution, alignment, and decision-making in a regulated medical device environment. The Senior Program Manager operates at both strategic and tactical levels, managing cross-program dependencies, influencing roadmap priorities, aligning and balancing across stakeholder expectations, and ensuring predictable delivery across programs.

To be successful the ideal candidate would be able to operate across ambiguity and detail — thinking across programs and portfolios while engaging deeply enough to keep execution moving with rigor, clarity, and accountability.

The Senior Program Manager owns execution and outcomes across multiple related programs, releases, product lines, or platform capabilities. This role is accountable for delivery predictability, cross-program alignment, dependency management, and resolution of systemic execution risks.

This includes:

• Owning delivery outcomes across related programs, releases, or product areas.

• Managing cross-program dependencies, sequencing, risks, resources, and tradeoffs.

• Influencing roadmap, release, and prioritization decisions.

• Monitoring and analyzing project trends to predict future operationational risks and mitigations.

• Driving alignment across functional leaders, executive stakeholders, and cross-functional teams.

• Facilitating decisions under ambiguity where priorities, constraints, or decision criteria may differ.

• Helping mature program management standards, planning discipline, operating cadence, decision frameworks, and cross-functional accountability.

• Essential duties and responsibilities include the following. Other duties may be assigned.
• Lead complex cross-functional Informatics R&D programs involving software, systems engineering, data platforms, cloud technologies, medical device software, and related informatics capabilities.
• Build and maintain integrated program plans covering scope, milestones, schedules, dependencies, resources, risks, decisions, execution priorities, and cross-program tradeoffs.
• Drive program execution through regular operating cadence, clear status reporting, decision tracking, risk management, dependency management, and timely escalation.
• Coordinate 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, program reviews, and planning discussions, ensuring actions, owners, decisions, risks, and open issues are clearly captured and followed through to closure.
• Lead programs involving SaMD and SiMD products deployed on electro-mechanical systems or cloud platforms, ensuring execution aligns with applicable design controls, quality system expectations, regulatory strategy, and controlled documentation processes.
• Partner with Systems Engineering, Regulatory Affairs, and Quality to coordinate development, verification, validation, risk management, and regulatory deliverables.
• Manage scope, schedule, risks, dependencies, and tradeoffs across related products, releases, and platform capabilities.
• Drive timely decision-making under ambiguity, including alignment on priorities, sequencing, tradeoffs, risks, and resource constraints.
• Support and influence roadmap, release, and portfolio planning for multiple related projects or product lines.
• Help mature Informatics R&D operating practices, including program management standards, planning discipline, execution cadence, decision frameworks, and cross-functional accountability.
• Use modern project planning, development support, and collaboration tools to create visibility, manage execution, track dependencies, and support decision-making.
• Communicate program status, risks, tradeoffs, recommendations, and decisions clearly to functional leaders, executive stakeholders, and cross-functional teams.

Requirements

• The requirements listed below are representative of the knowledge, skill, and ability required for this role.
• Experience 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 leading programs involving multiple cross-functional teams, related product releases, platform capabilities, or cross-product dependencies.
• Experience managing complex schedules, milestones, dependencies, risks, decisions, and deliverables across multiple functions.
• Experience operating in ambiguous environments where scope, priorities, technical constraints, business needs, or regulatory considerations may evolve over time.
• Experience working in a structured or regulated product development environment with formal planning, documentation, change control, decision tracking, and cross-functional governance.
• 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 lead through influence, build alignment, drive accountability, and facilitate decisions in a cross-functional environment.
• Strong written and verbal communication skills, including the ability to prepare clear executive-level updates, decision summaries, program reviews, and action-oriented meeting outputs.
• Strong analytical, organizational, and problem-solving skills, with the ability to translate ambiguity into actionable plans.
• Ability to manage multiple priorities in a fast-paced environment with changing business, technical, and resource constraints.

Education and/or Experience

• Bachelor’s degree in Engineering, Computer Science, Systems Engineering, Biomedical Engineering, Life Sciences, Business, or a related discipline with minimum 8 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.
• Advanced degree in Engineering, Computer Science, Biomedical Engineering, Business, or a related field preferred.
• PMP, PgMP, Agile, Scrum, Lean, Six Sigma, or similar project/program management certification preferred.
• Experience with internationally deployed teams would be considered a plus.

Equal Employment Opportunity & Other Disclosures

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $146,000 to $155,000 Full-Time Annual Salary