jessica claire montgomery street san francisco ca 94105 555 4321000 resumesampleexamplecom profile professional programproject manager engineer product development regulated complex crossfunctional multiproject environment medical device biomedical aerospace industry pmipmbok critical chain project management waterfall dependency structure matrix technical business leadership new product development design change project implementation facilitation planning organization skills resource scope schedule budget risk management skills design control fdas 21 cfr 82030 mechanical electromechanical plasticmold cadcaefea software systems engrg crossfunctional team leadership regulatory affairs ra post market 510k quality systems corrective preventive action accomplishments oversaw directed 160 projects ranging small large sizes varying complexities span 7 years met approximately 70100 assigned completion dates completed two projects therapeutic drug monitoring tdm group six months prior scheduled due date resulting manufacturing cost savings customer satisfaction integrated several complex procedures one process flow improved efficiencies 30 principal engineering service company 12 years growing company zero 10m us patents self sprinkler cap company microspray clutch assembly medical iv professional experience project engineermechanical engineer contractor 012010 current kb homes englewood co managed multiple engineering design change new product development projects high level disinfectant capital equipment systems orchestrated execution product development phase tasks within design control process including user requirements risk reviews design input productsystemcomponent specifications critical quality ctq design development plans cost analysis design outputs 3d design drawings prototyping first article inspection testing protocols reports design verification validation design reviews dhfdmr files manufacturing feasibility bill materials traceability design transfer collaborated quality assurance external internal manufacturing regulatory materials electronics software developers reliability global technical services supply chain labeling capa review board crb industrial design tooling vendors finance document control combined project management tools new product developmentdesign change process resolved gaps disconnects achieve project results developed robust project schedules monitored workflow achieve project deliverables milestones brought transparency project priorities negotiated directed resources meet project capacity milestones consistently communicated project status stakeholders aligned business objectives projects supported management aspects rd manufacturing prepare global launch project manager 082012 052013 danaher company city state provided project management expertise rd chemistry development group managed capa projects design changes new product development tdm assays phases reported vicepresident rd manager communicated project status project stakeholders developed project plans core leaders managers built project framework work breakdown structure wbs dependency structure matrix dsm ensuring completion project timeline applied methodology critical chain project management ccpm using prochain software create fever charts predict project health created project schedules according toll gate requirements optimized dependencies prevent task delays closely reviewed monitored scope creep collaborated phds scientists clinical lab technicians efforts toward reagent characterization formulation calibration manufacturing activities meet project goals managed design control ensure compliance worked manufacturing quality control crb regulatory approval phase reagentantibody design changes held regular project reviews project teams reviewed task due dates current issues manufacturing gemba meetings prepared project reports analyses presentations leadership committee gate reviews lead process improvement initiatives achieving deliverable timelines developed combined procedures improve project efficiency program managerproject managermechanical engineer 011999 012004 northrop grumman streamtech city state designed mechanical engineering components satellite space system subsystem payload integration group performed structural volume tolerance analysis supported telescopeoptics electromechanical cabling design heat transfer materials stress analysis groups worked test flight mode development phases project supervised contract engineers regarding project workload task completion dates group leaderproject engineer 1980 1992 rain bird sprinkler mfg city state led directed structural analysis plastic mold flow projects supervised mechanical engineersstress analysts worked cross functional teams performed plastic part design plastic injection simulation finite element analysis fea performed tolerance analysis plastic material selection water power driven mechanical systems design reverse engineering complex mechanism design irrigation products sprinkler rotors solenoid valves impact sprinklers electromechanical controllers spray heads bs degree mechanical engineering technology california state polytechnic university pomona ca mechanical engineering technology degree natural science chemistry citrus college azusa ca natural science chemistry university la verne mba finance university irvine regulatory certification education training affiliations project management institute pmi society mechanical engineers society plastic engineering skills ms project msoffice excel word powerpoint access outlook visio office 365 solidworks ideas prochain ccpm dsm cognition cockpit share point matrix one team center project management capa qms gdp design control 21 cfr 82030 risk reagent calibration product life cycle plm new product development change control taguchi continuous improvement dfma gdt managing technical environment