Medical Device Product Manager

BioTAB Healthcare is seeking a Medical Device Product Manager to oversee medical device product development end to end and ensure launch readiness while maintaining design controls, quality documentation, and healthcare compliance.

Responsibilities

• Lead medical device product development projects end to end across scope, requirements, schedule, budget, risks, dependencies, and launch readiness.
• Provide day-to-day direction and coaching to the department’s Product Manager and Project Manager for assigned work, with both continuing to report to the Senior Director.
• Run projects through BioTAB product development stage gates, ensuring documented criteria and approved decisions at each gate.
• Maintain project documentation needed for design controls and the quality system, collaborating closely with Quality and Regulatory.
• Coordinate cross-functionally with Sales, Operations, Billing, Customer Service, IT, Quality, and Regulatory to align teams for launch readiness.
• Manage external partners on assigned projects, including software developers and contract manufacturers, against agreed deliverables and dates.
• Run intake for new project requests by assessing scope, impact, and resource needs and bringing actionable recommendations to the Senior Director.
• Build and maintain a department system of record for projects, backlogs, and status, including transparent dashboards leadership can reference.
• Identify and address risks proactively; resolve issues within authority and escalate complex matters with viable options and data-backed recommendations.
• Leverage modern AI tools to accelerate planning, documentation, and analysis while strictly maintaining compliance and data quality standards.

Requirements

• Communicate clearly and constructively, collaborating effectively with stakeholders across technical and non-technical teams.
• Strong analytical and problem-solving ability to identify root causes of quality and delivery issues and implement corrective and preventive actions.
• Meticulous attention to detail to ensure accuracy across systems, records, documentation, and product requirements.
• Ability to organize and manage time effectively to coordinate multiple projects and product streams.
• Bachelor’s degree in Business Administration, Information Technology, Data Science, or a related field.
• Minimum 5 years of experience in data management, data quality, or data governance roles.
• Strong understanding of master data management (MDM) concepts, particularly in healthcare or insurance.
• Proven experience managing data governance for complex datasets (for example, facility, insurance, or similar master data).
• Excellent communication, interpersonal, and presentation skills.
• Proficiency in quality and/or systems planning software, including SalesForce, GSuite, and Tableau.

Technologies

• SalesForce
• GSuite
• Tableau

Compliance

• Ensure compliance with relevant healthcare regulations and internal policies, especially those related to external DME under ISO 13485.
• Assist in monitoring compliance with Medicare regulations.
• Adhere to regulations and agency policies related to patient intake and data management, including CMS and OFCCP guidelines related to the Quality Management System, documentation and process creation, and training.

Job Requirements & Physical Demands

• Must be able to lift 40 pounds; lift from the floor to waist level.
• Must be able to kneel, stoop, climb stairs, and reach with hands and arms.
• Reliable work transportation.
• Must pass an extensive background check.
• Strict adherence to HIPAA and Medicare Fraud, Waste, and Abuse privacy regulations in all patient interactions.