Sr. R&D Program Manager

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 develo