Project Management Director - ZipRecruiter : Job Details

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 Prevo 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 Operations teams.

Execution and Cross-Functional Alignment

• Coordinate cross-functional team activities to bring projects to completion on time and within budget.
• Develop integrated timelines, project charters, and resource plans to ensure timely delivery of product and clinical milestones.
• Coordinate the 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.
• Lead the preparation of project status reports, stage-gate reviews, and executive updates.

Skills

• Strategic problem solver with operational discipline.
• Clear, confident communicator with the 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 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 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 without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. We are committed to providing reasonable accommodations for candidates with disabilities. If you need assistance or accommodation during the recruitment process, please let us know.

Compensation

We offer a competitive salary and benefits, including 100% coverage of healthcare, dental, and vision premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $165,000 - $185,000 annually, plus bonus potential. Compensation may vary based on skills, experience, and attributes.