Surgical Product Manager

Job Description

Product Strategy & Roadmap

• Own the product roadmap for assigned products and clinical applications, with an emphasis on Spine and expansion into additional surgical disciplines.

• Ensure product strategy aligns with company objectives, clinical needs, customer feedback, and market opportunities.

• Define product requirements, prioritize features, and manage trade-offs across clinical, technical, regulatory, and business constraints.

• Conduct ongoing competitive analysis, market research, and voice-of-customer activities to identify opportunities across surgical specialties. Agile Execution & Program Management

• Serve as Spine Manager for assigned projects, partnering closely with engineering, quality, clinical, and design teams.

• Manage backlogs, user stories, bugs, and sprint planning using Jira and related task management tools.

• Ensure development activities align with design controls and quality system requirements, including the use of Ketryx and other regulated software tools.

• Participate in testing processes to validate engineering outputs and ensure conformance to user and product requirements. Regulatory & Quality Collaboration

• Collaborate closely with Regulatory Affairs to support FDA clearance activities, including the generation and management of Software Requirements Specifications (SRS), user manual updates, and other required documentation.

• Contribute to regulatory strategy by providing product intent, clinical use cases, risk considerations, and competitive context across applicable surgical disciplines.

• Support the preparation and review of regulatory submissions, labeling, and responses to FDA questions.

• Ensure product requirements and changes are documented in compliance with applicable regulatory and quality standards.

Skills and Requirements

Required Qualifications

• Bachelor’s degree in engineering, life sciences, business, or a related field; advanced degree is a plus.
• 2+ years of clinical support experience.
• Experience and/or interest working with agile development processes and serving as a sprint or backlog owner.
• Familiarity with regulated software and quality systems, including Jira, Ketryx, or similar tools.
• Experience collaborating with Regulatory Affairs on FDA submissions and clearance activities.
• Comfort working in the operating room environment and engaging directly with surgeons and clinical staff across different specialties.
• Ability to understand and adapt to different surgical workflows and clinical applications.
• Strong analytical, communication, and cross-functional leadership skills.
• Willingness and ability to travel approximately 35%, including early mornings and extended OR days.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].