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 responsibleforproductdevelopment,resourceandprojectmanagementactivities associatedwithexecuting the company'sgoalsforproduct commercialization and post-commercialization activities. You will also have ownership for company’s Product Development Process (PDP). You will be responsible forgaining cross functional alignment onstrategicvisionandgoalsofprojects, meetingprojectgoalsandensuringthat appropriateresourcesare identifiedandallocated.

Qualifications

Education and Training:

BS in Engineering and a minimum of 8 years’ experience in medical devicedevelopment, includingexperiencein leadership rolesinallphasesofproductdevelopment

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 anddevelopproduct(s)infullcompliance with thecompany's Design Control requirements andconsistentwith FDA, ISO andMDD requirements.
• Developandimproveproductlinesandstrategize newproductplansin­ conjunction with GalvanizeManagement.
• Partner with operations on initiatives related to commercial products.
• Managetechnicalpersonnelandtheiractivities involvedin thedevelopment ofnewand improvedproductsand/or manufacturingprocesses.
• Ensurethatdevelopmentactivitiesareproperlydocumentedthroughlab notebook,historyfile,andotherrecords.
• Manageandcoordinateallcross-functionalactivitieswithin theprojectand consistentwith company's PDP.
• Coordinatecross-functional alignment andsupportforprogramsuccess.
• Manageoutsidevendorsandcontractors that provide productsorservicesto Galvanize.
• Createandmaintainprojecttimelineandbudgetsforinternalandoutside development projects.
• Identify issues andrecommendsolutionsfor productsindevelopment and in commercial production
• Contribute ideastonewproducts,asdefinedbyproject scope.
• Identify and reviewtestmethods,acceptance criteria, andtest equipmentforallstagesof productdevelopment.
• Coordinateand participate in events, which providefeedbacksuchas pre-clinicalstudies,physician interfacemeetings,andclinicalstudies.
• Ensurethatproductssatisfyacceptablequalitystandardsandcustomerneeds, withconsensusfromcrossfunctionalgroups.
• Review andapprovedocumentsasspecifiedinDesignControlSOP.
• CompiletheDesign History File andconductdesign reviews incompliancewith Design Control procedures.
• Ensurethatproductshavecapablemanufacturingprocessesandthatprocess validations are completed.
• Interact with cross-functional groups to ensure that products are compatible with accessoryproducts in theintended operating system,andhavethe necessaryshelf life,biocompatibility,packaging,regulatory,andperformance 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.