Sr. R&D Program Manager

About Galvanize Therapeutics Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.

About the role The Sr. R&D Program Manager is responsible for product development, resource and project management activities associated with executing the company's goals for product commercialization and post-commercialization activities. You will also have ownership for company’s Product Development Process (PDP). You will be responsible for gaining cross functional alignment on strategic vision and goals of projects, meeting project goals and ensuring that appropriate resources are identified and allocated.

Qualifications

Education and Training:

BS in Engineering and a minimum of 8 years’ experience in medical device development, including experience in leadership roles in all phases of product development

Skills and Experience:

• PMP certification is highly desirable
• Knowledge of QSR, MDR and applicable Quality System Standards.
• Experience with medical device development of both disposable and capital equipment
• Experience taking a product from concept through clinical or commercial release.
• Ability to work in a fast-paced environment while managing multiple priorities
• Excellent communication skills both verbal and written

Key Responsibilities

• Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements.
• Develop and improve product lines and strategize new product plans in­ conjunction with Galvanize Management.
• Partner with operations on initiatives related to commercial products.
• Manage technical personnel and their activities involved in the development of new and improved products and/or manufacturing processes.
• Ensure that development activities are properly documented through lab notebook, history file, and other records.
• Manage and coordinate all cross-functional activities within the project and consistent with company's PDP.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors that provide products or services to Galvanize.
• Create and maintain project timeline and budgets for internal and outside development projects.
• Identify issues and recommend solutions for products in development and in commercial production
• Contribute ideas to new products, as defined by project scope.
• Identify and review test methods, acceptance criteria, and test equipment for all stages of product development.
• Coordinate and participate in events, which provide feedback such as pre-clinical studies, physician interface meetings, and clinical studies.
• Ensure that products satisfy acceptable quality standards and customer needs, with consensus from cross functional groups.
• Review and approve documents as specified in Design Control SOP.
• Compile the Design History File and conduct design reviews in compliance with Design Control procedures.
• Ensure that products have capable manufacturing processes and that process validations are completed.
• Interact with cross-functional groups to ensure that products are compatible with accessory products in the intended operating system, and have the necessary shelf life, biocompatibility, packaging, regulatory, and performance reviews.

This role pays between $160,000 and $175,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.

Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.