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 associatedwithexecutingthe 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 appropriateresourcesareidentifiedandallocated.

Qualifications

Education and Training:

BS in Engineering and a minimum of 8 years’ experience in medical devicedevelopment, includingexperienceinleadership 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)infullcompliancewith thecompany'sDesignControlrequirements andconsistentwith FDA, ISO andMDDrequirements.
• Developandimproveproductlinesandstrategize newproductplansin­ conjunction with GalvanizeManagement.
• Partner with operations on initiatives related to commercial products.
• Managetechnicalpersonnelandtheiractivitiesinvolvedin thedevelopment ofnewand improvedproductsand/ormanufacturingprocesses.
• Ensurethatdevelopmentactivitiesareproperlydocumentedthroughlab notebook,historyfile,andotherrecords.
• Manageandcoordinateallcross-functionalactivitieswithin theprojectand consistentwithcompany'sPDP.
• Coordinatecross-functionalalignment andsupportforprogramsuccess.
• Manageoutsidevendorsandcontractorsthat provide productsorservicesto Galvanize.
• Createandmaintainprojecttimelineandbudgetsforinternalandoutside development projects.
• Identify issues andrecommendsolutionsfor productsindevelopment and in commercial production
• Contributeideastonewproducts,asdefinedbyproject scope.
• Identify and reviewtestmethods,acceptancecriteria, andtestequipmentforallstagesof productdevelopment.
• Coordinateand participate in events,which providefeedbacksuchas pre-clinicalstudies,physicianinterfacemeetings,andclinicalstudies.
• Ensurethatproductssatisfyacceptablequalitystandardsandcustomerneeds, withconsensusfromcrossfunctionalgroups.
• Review andapprovedocumentsasspecifiedinDesignControlSOP.
• CompiletheDesignHistory File andconductdesign reviews incompliancewith Design Controlprocedures.
• Ensurethatproductshavecapablemanufacturingprocessesandthatprocess validations arecompleted.
• Interact with cross-functional groups to ensure that products are compatible with accessoryproductsin theintendedoperating system,andhavethe necessaryshelf life,biocompatibility,packaging,regulatory,andperformancereviews.

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.