Jason Rinehart's Location
San Marcos, California, United States, United States
Jason Rinehart's Contact Details
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About Jason Rinehart
Highly experienced in medical device research and development: - R&D staff management and core team leadership; - Proven record of delivering high performing Class II and III designs to key markets; - Extensive experience in design development, design verification, validation/performance testing, design and process specification setting, process validation, design transfer, and launch readiness; - Have collaborated closely with interventional key opinion leaders (KOL) and senior corporate leadership to ensure designs met both user needs and business targets such as cost of product; - Extensive experience traveling domestically and internationally for clinical product support, resolve supplier issues, support for product pipeline introductions, and pre-launch sales and marketing activities.Strong experience supporting biotech and pharmaceutical clients in pilot operations, lab and cGMP capital projects management. Also, experienced in supporting special OPEX projects such as biologics process development at CMOs, and a client's operational readiness for a key viral vector clinical manufacturing facility.
Jason Rinehart's Current Company Details
Highly experienced Principal Engineer and Technical Project Manager open to new opportunities.
Jason Rinehart Work Experience Details
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Principal Engineer, Biotech And Pharmaceutical IndustriesSequoia Consulting Group,Llc Jul 2020 - May 2024Solana Beach, California, United States -
Lead Consultant, Medical Device & Biotech IndustriesSequoia Consulting Group,Llc Aug 2018 - Jul 2020Solana Beach, Ca
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Technical Project Lead For Gmp And Non-Gmp Operational ReadinessA Leading Developer Of Car-T And Other Biologics Therapies Apr 2020 - Mar 2024Oceanside, California, United StatesCurrently lead several GMP and non-GMP projects supporting upstream and downstream process development through automation improvements and integrations, bioreactor and lab equipment acquisition, installation and qualifications.Co-led a large effort from Q2 2020 through to Q1 2021 to prepare a new viral vector manufacturing facility for operation readiness. Responsible for the oversight of multiple workstreams supporting readiness to execute process performance qualification runs and stability runs, including suite and QC lab qualifications, lab and process equipment CQV, test method transfer/validation, and materials acquisition and release testing.
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Senior Systems EngineerAn Industry Leader In Continuous Glucose Monitoring Jun 2019 - Jan 2020San Diego County, California, United StatesDeveloped and deployed robust equipment development and qualification processes and procedures. These efforts enabled my client to streamline the flow of new equipment from URS to a qualified, reliable production machines able to be serviced and re-qualified quickly with minimal down time.
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Senior Project LeadA Leading Dna Sequencing Corporation Aug 2018 - Apr 2019Greater San Diego AreaLed cross-functional platform operations teams, moving sequencing system consumable products from development into pilot phases and transfer phases. Products in scope: comsumable reagent and flow cell cartridges, and reagents. Oversight of high-volume manufacturing validations of integrated machinery and processing. Daily management of OPS teams and technical huddles. Support tiger team actions and RCA initiatives. Present weekly and monthly project status to cross-functional senior leadership.
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Director Of Advance Development And Program ManagementObalon Therapeutics Nov 2017 - Jun 2018Carlsbad, CaLed cross-functional activities of New Product Innovation teams including oversight of project leadership and design verification activities, clinical trial readiness, and market readiness.Chief designer of the next-generation gastric balloon catheter, focusing on cost of goods (COGs) reduction through efficient processing, Lean methodologies and Six Sigma principles. -
Senior Manager, Engineering ServicesPhilips Image Guided Therapy Aug 2016 - Jun 2017Del Mar, CaLed the Engineering Services group to support New Product Innovation (NPI) teams, providing new or improved tools and processes resulting in cost reduction/avoidance and on-time product launch.Configured and deployed a new Stage Gate process at Volcano, including new technical and business deliverables, Stage Gate procedure, gate decision forms, and a gate presentation template. Coached NPI teams through continuous improvement resulting all NPI teams demonstrating competency in using the deployed Stage Gate process.Created a highly effective document collaboration procedure and tools for use by NPI teams.Owned the deployment of established Philips engineering processes and tools, most notably Design for Reliability. Served as the owner for R&D process integration as Volcano integrated into Philips.
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Senior Program ManagerAlphatec Spine Aug 2015 - Aug 2016Led new product development programs through the phase gate design control process, delivering innovative thoracolumbar solutions into business critical market opportunities for spinal degenerative and deformity conditions.Managed efforts cross-functionally and with external business partners and suppliers to ensure milestones are met. Led efforts to establish legal and quality agreements with key suppliers. -
Senior Principal EngineerEndologix Inc May 2014 - Jun 2015Irvine, CaDeveloped Class III implants for the treatment of paravisceral aortic aneurysms.Led a cross-functional team and outside consultants utilizing computational analysis and bench testing to re-produce a Class III implant clinical failure. Successful results were the basis of a business-critical regulatory response. -
Principal EngineerNovo Engineering Feb 2013 - May 2014Vista, CaDeveloped business-critical design verification tests for NOVO Engineering clients. Trained client staff on execution of tests and interpretation of data. Authored verification test protocols and reporting of results for key clients in support of regulatory submissions. -
R&D Manager / Sr. Principal EngineerAbbott Vascular Devices Sep 2005 - 2012Southern CaliforniaManage and lead R&D teams to design, prototype and operationally qualify (OQ) processes incorporating new technologies and materials.Perform Proof-of-Concept builds and testing. Collaborate for readiness with Operations, Regulatory Affairs and Marketing for clinical builds, FIM trials and product launchs.Closely collaborate with Clinical Research group to develop test models and perform pre-clinical performance testing. Work with KOL US/OUS cardiologists and CMO in performance testing of next-generation products. Travel internationally with senior staff members to present new product pipeline to targeted markets. Present next-generation device designs to sales force at pre-launch meetings. -
Principal EngineerAbbott Vascular Nov 2003 - Sep 2005Southern CaliforniaR&D team leader for next-generation Class III drug-coated devices. Led peripheral drug-eluting self-expanding stent program from concept to FIM safety trial readiness. Managed all engineering team tasks and activities, including test protocol development and review, test execution, and testing report review. Provided weekly program updates to senior management, operations and marketing. Managed DES production line equipment qualification efforts, including in-house work by industry consultants.
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Project Manager And Senior Design EngineerIntraluminal Therapeutics Oct 2002 - Nov 2003Designed novel, CAD-designed radio-frequency micro-ablation catheter. Device used adjunctively with company’s primary device (Safe-CrossTM) in coronary and peripheral arteries for use in crossing Chronic Total Occlusion (CTOs). Fully compatible with IntraLuminal’s existing CE Marked RF generator. Led project into Development phase in compliance with company’s design control requirements. Developed new in vitro test methods, including tissue ablation and penetration, to ensure catheter design meets or exceeds functional requirements to initiate a porcine CTO animal study. Managed program from its inception, including writing financial impact, developing an annual budget, monthly costs associated with the primary supplier, and contributing to the market needs assessment.
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Senior Design Engineer, Resorbable Polymer Stent ProgramReva Medical, Incorporated Jun 2001 - Jun 2002Original concept designer of CAD-designed, balloon-deployable, fully-resorbable Tyrosine-derived polymer stent based on slide-and-lock intellectual property. Demonstrated functional feasibility resulting in deployment reliably and radial strength exceeding minimum clinical requirements. Achievements led to a sub-acute animal study evaluating vascular response to the licensed polymer. Introduced pre-clinical bench testing concepts to REVA Medical for stent performance feedback. Device used First-In-Man in 2007 (EU).
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Senior Research & Development EngineerGuidant Corporation, Vascular Intervention Bu Aug 1998 - Jun 2001Worked directly with leading interventional cardiologists, including: Drs.Colombo, Braden, Moses, Baim, Mousa, Simonton. Worked directly with leading US and OUS cardiologists in pre-clinical development and in vivo evaluation, including design validation and operator technique development for the FlexiCut DCA system. Worked closely with histologists and pathologists in support of FDA/PMA(s) filings. Developed in vitro and ex vivo system test models to verify the performance of the cutting mechanism. Concept phase stent delivery system design engineer, Frontier Bifurcation Stent System. Developed innovative in vitro models in support of vascular device R&D teams. Conducted in-hospital Physician Preference Testing of new Atherectomy device (FlexiCut).
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Product Development EngineerMcghan Medical Corporation Nov 1996 - Jul 1998Developed implant prototypes based on performance needs and product specification requirements. Worked in the Republic of Ireland to integrate new products lines into manufacturing. Provided support for Regulatory Affairs in the submission of Pre-Market Approvals (PMA).
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Manufacturing EngineerGeneral Dynamics Corporation, Space Systems Division, San Diego, Ca. Sep 1989 - 1993Manufacturing Engineer, Atlas-Centaur and Titan-Centaur Launch Vehicle programs.
Jason Rinehart Skills
Medical Devices
Design Control
R&d
Validation
Biomedical Engineering
Engineering
Catheters
Cross Functional Team Leadership
Iso 13485
Fda
Product Development
Quality System
Design Of Experiments
Testing
Manufacturing
Capa
V&v
Regulatory Affairs
Research And Development
Gmp
Iso
Commercialization
Root Cause Analysis
Design For Manufacturing
Product Management
Iso 14971
Fmea
Product Design
Biomaterials
Drug Delivery
Clinical Development
Six Sigma
Management
Lean Manufacturing
Manufacturing Engineering
Change Control
Managerial Skills
Personnel Management
Program Management
Dmaic
Iso 10555
Iso 25539
Iso 10993
Iso 11607
Iso 11608
Iso 15223
Astm F1980
Astm F1929
Astm F2096
Autoinjectors
Jason Rinehart Education Details
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Biomaterials, Biomechanics -
Mechanical Engineering
Frequently Asked Questions about Jason Rinehart
What is Jason Rinehart's role at the current company?
Jason Rinehart's current role is Highly experienced Principal Engineer and Technical Project Manager open to new opportunities..
What is Jason Rinehart's email address?
Jason Rinehart's email address is ja****@****ott.com
What is Jason Rinehart's direct phone number?
Jason Rinehart's direct phone number is 650-474*****
What schools did Jason Rinehart attend?
Jason Rinehart attended Clemson University, California Polytechnic State University-San Luis Obispo.
What skills is Jason Rinehart known for?
Jason Rinehart has skills like Medical Devices, Design Control, R&d, Validation, Biomedical Engineering, Engineering, Catheters, Cross Functional Team Leadership, Iso 13485, Fda, Product Development, Quality System.
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Jason Rinehart
Claremore, Ok610thmagnitude.com, cox.net, pbsnow.com, bellsouth.net, avanade.com, rackspace.com10 +140553XXXXX
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Jason Rinehart
Now Seeking Full-Time Work Opportunities As An Electrical Hardware Engineer Or SimilarBoston, Ma1wit.edu -
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Jason Rinehart
Cybersecurity Risk And Compliance Engineer | External Audits | Data Analytics | Vulnerability Management | Project ManagementHolly Springs, Nc
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