Medical Device Product Development Manager

MEDICAL DEVICE PRODUCT DEVELOPMENT MANAGER

For more than 20 years, BioTAB Healthcare, LLC has supported patients with lymphatic, wound, and circulatory disorders through proven treatment solutions. Headquartered in Missouri, we provide pneumatic compression devices and personalized service to help improve patient outcomes and quality of life. As a family-owned company, we take pride in delivering expert care with a personal touch service. 

Key Responsibilities

• Lead projects end to end: 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 on assigned work, while both continue to report to the Senior Director.
• Run projects through BioTAB's 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 across Sales, Operations, Billing, Customer Service, IT, Quality, and Regulatory so each function is fully aligned and ready at launch.
• Manage external partners on assigned projects, including software developers and contract manufacturers, against agreed deliverables and dates.
• Run intake for new project requests: assess scope, impact, and resource needs, and bring actionable recommendations to the Senior Director.
• Build and maintain the department's system of record for projects, backlogs, and status, with transparent dashboards leadership can reference seamlessly.
• Identify and address risks proactively; resolve issues within scope of 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.

Compliance

1. Ensure compliance with relevant healthcare regulations and internal policies, especially those related to external DME under ISO 13485. 
2. Assist in monitoring compliance with Medicare regulations. 
3. Adhere to all relevant regulations and agency policies regarding patient intake and data management, including but not limited to: CMS and OFCCP guidelines related to our Quality Management System, documentation and process creation and training.

Qualifications

• Communicate clearly and constructively, collaborating effectively to influence various stakeholders, including technical and non-technical teams.
• Apply strong analytical and problem-solving abilities to identify root causes of quality and delivery issues and implement corrective and preventive actions.
• Ensure accuracy across systems, records, documentation, and product requirements through meticulous attention to detail.
• Effectively organize and manage time to coordinate multiple projects/product streams and ensure timely processing of information.

Experience 

• Bachelor’s degree in Business Administration, Information Technology, Data Science, or a related field.
• Minimum of five years of experience in data management, data quality, or data governance roles.
• Strong understanding of master data management (MDM) concepts, particularly in the healthcare or insurance sector.
• Proven experience managing data governance for complex data sets, including facility, insurance, or similar master data.
• Excellent communication, interpersonal, and presentation skills.
• Proficiency in quality and/or systems planning software (SalesForce, GSuite, Tableau).

Job Requirements & Physical Demands 

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

This job description outlines essential duties but is not exhaustive. Employees may be assigned other tasks. All duties are subject to modification for disability accommodation. Successful performance requires specific skills and abilities. This document sets minimum requirements and does not imply an employment contract. The company is an equal opportunity employer, drug-free workplace, and complies with ADA regulations as applicable. BioTAB Healthcare is an equal opportunity employer and drug-free workplace. All duties are subject to modification for disability accommodation in compliance with ADA regulations. This document outlines minimum requirements and does not imply an employment contract.

BioTAB Healthcare is an Equal Opportunity Employer. We are committed to fostering, cultivating, and preserving a culture of diversity, equity, inclusion, and belonging. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.