Senior Medical Device R&D Program Lead

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

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

Short- and long-term disability

401(k)

Flexible paid time off

Job summary

Galvanize Therapeutics is seeking a Senior R&D Program Manager to lead product development and manage resources for commercialization and post-commercialization activities. You will own the Product Development Process (PDP) and align cross-functional goals to meet project objectives.

Required BS in Engineering with 8+ years in medical device development, including leadership across all product development phases.

Qualifications

• PMP certification is 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 manage multiple priorities in a fast-paced environment.
• Excellent verbal and written communication skills.

Responsibilities

• Design and develop products in compliance with Design Control, FDA, ISO and MDD requirements.
• Develop and improve product lines and strategize new product plans with Galvanize Management.
• Partner with operations on initiatives related to commercial products.
• Manage technical personnel and their activities in development and manufacturing.
• Ensure development activities are documented in lab notebooks and history files.
• Coordinate cross-functional activities within the PDP and project timelines.
• Coordinate alignment and support for program success across functions.
• Manage outside vendors and contractors for products or services.
• Create and maintain project timelines and budgets for development projects.
• Identify issues and propose solutions for development and production.
• Contribute ideas for new products within project scope.
• Review test methods, acceptance criteria, and equipment for all stages.
• Coordinate and participate in pre-clinical, physician interface, and clinical studies.
• Ensure products meet quality standards and customer needs with cross-functional consensus.
• Review and approve documents per Design Control SOP.
• Assemble the Design History File and conduct design reviews.
• Ensure manufacturability and process validations for products.
• Interface with cross-functional groups to ensure compatibility with accessory products and regulatory reviews.

Skills

PMP certification

QSR, MDR knowledge

Medical device development experience

Clinical or commercial release

Strong communication skills

Fast-paced environment management

Education

BS in Engineering

Job description

Galvanize Therapeutics is seeking a Senior R&D Program Manager to lead product development and manage resources for commercialization and post-commercialization activities. You will own the Product Development Process (PDP) and align cross-functional goals to meet project objectives.

Required BS in Engineering with 8+ years in medical device development, including leadership across all product development phases.