Hybrid Technical Program Manager

at Biora Therapeutics

• Job title: Technical Program Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $150,000 - $190,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, San Diego, United States

About the role

• Technical Program Manager overseeing cross-functional teams for complex projects in medical device development. Leading project management discipline at Biora Therapeutics specializing in ingestible drug-device combinations.

Responsibilities

• Develop comprehensive project plans, including timelines, milestones, and deliverables, aligned with corporate objectives.
• Facilitate detailed planning sessions and ensure all project activities are tracked and managed to completion.
• Integrate design controls and risk management processes into project plans, ensuring compliance with regulatory standards.
• Lead and coordinate cross-functional project team meetings, document decisions, and assign clear ownership for action items.
• Define and communicate roles and responsibilities for all team members.
• Foster accountability and collaboration across internal and external stakeholders.
• Oversee the completion of design control documentation, including requirements flow-down, capabilities flow-up, and critical-to-quality (CTQ) specifications.
• Ensure product and system-level requirements are established, integrated, verified, and validated throughout the project lifecycle.
• Collaborate with Quality Assurance to maintain compliance for project documentation and design history files.
• Drive resource allocation and task management, resolving conflicts and prioritizing activities with department managers.
• Proactively identify project risks, develop mitigation strategies, and maintain unified cadence to meet milestones.
• Establish and publish project dashboards and key performance indicators (KPIs) to monitor progress and highlight risks.
• Implement new standards for requirements and specifications development, management, and traceability.
• Continuously improve project management processes to enhance efficiency and compliance.

Requirements

• Bachelor’s degree in engineering or equivalent training.
• Minimum 3 years’ experience in medical device product development (Class II or III devices; combination products preferred).
• Experience in the implementation and integration of FDA 21 CFR 820, including practical application in device development.
• Demonstrated expertise in design controls, risk management, and product realization.
• Familiarity with IND regulatory and commercialization pathway; knowledge of medical device regulatory requirements preferred.

Benefits

• Health Insurance: Fully company-paid premiums for employees’ medical, dental, and vision plans.
• Retirement Savings: Employer match up to 6% of annual salary to employees’ 401(k) plan when they save for retirement.
• Spending Accounts: FSA plans offered for both healthcare and dependent care; HSA available with high-deductible health plans.
• Income Protection: Fully paid basic life, AD&D, short-term disability, and long-term disability insurance for employees.
• Paid Time Off: Paid holidays and paid time off.
• Flexible Work Hours: Core hours 9:30 AM to 3:00 PM with flexibility to set your own schedule, depending on role.
• Parental Leave: Fully paid parent & child bonding leave for employees with one year of service.
• Workplace Perks: Complimentary beverages and snacks.