Sr. R&D Program Manager

Galvanize•Redwood City, CA

1d•$160,000 - $175,000

About The Position

The Sr. R&D Program Manager is responsible for product development, resource and project management activities that support the company’s product commercialization goals and post-commercialization activities. The role owns the company’s Product Development Process (PDP), builds cross-functional alignment around project vision and goals, and ensures projects meet their goals with appropriate resources identified and allocated. The position works with Galvanize Management and Operations to develop and improve product lines, plan new products, and support commercial products. It manages technical personnel, cross-functional project activities, outside vendors and contractors, project timelines, and budgets. The role also ensures design-control compliance, complete documentation and design history files, product quality, capable manufacturing processes, and appropriate testing, validation, regulatory, packaging, biocompatibility, performance, and shelf-life reviews. The role pays $160,000 to $175,000 per year. Actual base pay depends on location, skills, qualifications, and experience. Galvanize offers full-time employees medical, dental, and vision coverage, life insurance, short- and long-term disability protection, a 401(k), and flexible paid time off.

Requirements

Bachelor of Science in Engineering.
At least 8 years of experience in medical device development, including leadership roles in all phases of product development.
Knowledge of QSR, MDR, and applicable Quality System Standards.
Experience with medical device development involving both disposable products 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 verbal and written communication skills.

Nice To Haves

PMP certification is highly desirable.

Responsibilities

Design and develop products in compliance with company Design Control requirements and applicable 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 activities involved in developing new and improved products and manufacturing processes.
Ensure development activities are properly documented in lab notebooks, history files, and other records.
Manage and coordinate cross-functional project activities in accordance with the company’s PDP.
Coordinate cross-functional alignment and support for program success.
Manage outside vendors and contractors providing products or services to Galvanize.
Create and maintain timelines and budgets for internal and external development projects.
Identify issues and recommend solutions for products in development and commercial production.
Contribute ideas for new products within the project scope.
Identify and review test methods, acceptance criteria, and test equipment for all stages of product development.
Coordinate and participate in feedback-gathering events, including pre-clinical studies, physician interface meetings, and clinical studies.
Ensure products meet acceptable quality standards and customer needs, with cross-functional consensus.
Review and approve documents as specified in the 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.
Work with cross-functional groups to ensure product compatibility with accessory products in the intended operating system and completion of necessary shelf-life, biocompatibility, packaging, regulatory, and performance reviews.