Senior Medical Device R&D Program Manager

Galvanize Therapeutics; Redwood City (CA); On-site; USD 160,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Short- & long-term disability

401(k)

Flexible paid time off

Job summary

Galvanize Therapeutics is a biomedical platform company focused on Pulsed Electric Field Systems to improve patient outcomes. The Sr. R&D Program Manager leads product development, PDP ownership, and cross-functional alignment to meet strategic goals for product commercialization and post-commercialization activities.

The role requires a BS in Engineering with 8+ years in medical device development, leadership experience, and strong communication skills. PMP is desirable.

Qualifications

• BS in Engineering and at least 8 years in medical device development.
• PMP certification is highly desirable.
• Knowledge of QSR, MDR and applicable Quality System Standards.
• Experience with development of disposable and capital equipment.
• Experience taking a product from concept through clinical or commercial release.
• Excellent communication skills both verbal and written.

Responsibilities

• Design and develop product(s) in full compliance with the company's Design Control requirements and 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 development of new and improved products and/or manufacturing processes.
• Ensure development activities are properly documented through lab notebooks, history files, and other records.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors providing products or services to Galvanize.
• 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 providing feedback such as pre-clinical studies and clinical studies.
• Ensure products satisfy acceptable quality standards and customer needs with cross-functional consensus.
• 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 products have capable manufacturing processes and that process validations are completed.
• Interact with cross-functional groups to ensure compatibility with accessory products and regulatory, packaging, and performance reviews.

Skills

PMP certification

Quality systems

Medical device development

Concept to release

Communication

Multitasking

Leadership

Education

BS in Engineering

Job description

Galvanize Therapeutics is a biomedical platform company focused on Pulsed Electric Field Systems to improve patient outcomes. The Sr. R&D Program Manager leads product development, PDP ownership, and cross-functional alignment to meet strategic goals for product commercialization and post-commercialization activities.

The role requires a BS in Engineering with 8+ years in medical device development, leadership experience, and strong communication skills. PMP is desirable.