Project Management Director

Position Description

We are seeking an experienced and strategic Director of Project Management to lead the execution and delivery of Carlsmed’s cross-functional initiatives. This role is critical in scaling our operations, ensuring regulatory compliance, and driving the commercialization of groundbreaking surgical solutions. The ideal candidate will have a strong background in medical device development, software project management, excellent leadership skills, and a deep understanding of regulated environments.

Responsibilities

Program & Portfolio Leadership

• Manage a portfolio of programs supporting Carlsmed’s product roadmap, including aprevo® system enhancements, product development (device and software), and customer engagement platforms


• Establish and continuously improve project management standards, processes, and toolkits tailored for a high-growth MedTech environment


•  Oversee strategic initiatives across Development, Medical, Technology, and Operation steams

Execution and Cross-Functional Alignment

• Coordinate cross-functional teams activity to bring projects to completion both on time and within budget.

• Develop integrated timelines, project charters, and resource plans to ensure timely and efficient delivery of product and clinical milestones


• Coordinate cross-functional execution of product development, design control activities, clinical study operations, and regulatory submissions


• Track project KPIs and proactively manage risks

Stakeholder Engagement

• Communicate regularly with executive leadership to provide project updates, identify bottlenecks, and propose course corrections


• Serve as a key liaison between product, technology, operations, quality, regulatory, and commercial teams to ensure alignment and clarity of objectives


• Lead the preparation of project status reports, stage-gate reviews, and executive-level updates

Skills

• Strategic problem solver with operational discipline


• Clear, confident communicator with ability to influence at all levels


• Passion for innovation in healthcare and making a meaningful clinical impact


• Comfortable navigating ambiguity in a fast-paced, entrepreneurial environment

• Proven ability to align diverse teams—including Product, Engineering, Operations, Medical Affairs, and Marketing—around complex program goals.


• Expertise in planning, executing, and delivering large-scale initiatives


• Exceptional verbal and written skills to influence, align, and update stakeholders from engineering teams to executive leadership.

• Cultivate a culture of accountability, collaboration, and transparency across program teams

Qualifications

• Bachelor’s degree in engineering, computer science, biomedical sciences, or related technical discipline


• 10+ years of progressive experience in program or project management within a regulated medical device or digital health environment


• 5+ years of leadership experience managing teams and cross-functional programs


• PMP, or equivalent certification


• Knowledge of medical device lifecycles, design control processes, and FDA regulatory requirements.


• Expertise in project management, design control, risk management, and compliance under FDA 21 CFR and ISO 13485


• Familiarity with product lifecycle tools like MS Project, Smartsheet, Jira, Confluence, or equivalent

Equal Opportunity Employer

Carlsmed is an equal-opportunity employer.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need any assistance or accommodation due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is: $165,000 - $185,000 annually plus a bonus opportunity. Compensation may vary based on related skills, experience, and relevant key attributes.