Senior Medical Device Program Lead

BioTissue, Inc.; Miami (FL); On-site; USD 124,000 - 156,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) Retirement Savings Plan

Paid Time Off and Holidays

Equity or Stock Programs

Tuition Reimbursement and Development

Performance-Based Incentives

Job summary

BioTissue, Inc. in Miami, FL seeks a Senior Technical Program Manager – Product Development to lead cross-functional medical device programs from concept through commercialization, using stage-gate processes.

You will partner with Regulatory, Quality, R&D, Manufacturing and Clinical teams to drive strategy, budgets, risk management, and timely delivery of milestones, ensuring alignment with IND/BLA strategies and QBD principles.

Qualifications

• Bachelor's degree in a technical field; advanced degree preferred.
• 8+ years in regulated product development or life sciences.
• 5+ years leading cross-functional product development projects.
• Experience with IND/BLA submissions; device/combination product a plus.
• Knowledge of FDA regulations and ISO 13485, ISO 14971, design controls.

Responsibilities

• Lead programs through feasibility, development, validation, regulatory submission, transfer and launch readiness.
• Develop integrated plans, schedules, budgets, resources, and milestones.
• Translate strategies into cross-functional work plans; manage risks and decisions.
• Coordinate laboratories, CROs, CMOs, and other partners.
• Ensure alignment with business cases and portfolio priorities.

Skills

Cross-functional leadership

Regulated product development

Risk management

Executive communication

Project scheduling

Education

Bachelor's degree in Engineering/technical field

Advanced degree preferred

Job description

BioTissue, Inc. in Miami, FL seeks a Senior Technical Program Manager – Product Development to lead cross-functional medical device programs from concept through commercialization, using stage-gate processes.

You will partner with Regulatory, Quality, R&D, Manufacturing and Clinical teams to drive strategy, budgets, risk management, and timely delivery of milestones, ensuring alignment with IND/BLA strategies and QBD principles.