Lindy Vejar

Lindy Vejar Email and Phone Number

MBA/Program Management/NPI/Manufacturing Engineering/Continuous Improvement/Lean Six Sigma Black Belt @ CM Health Systems
Lindy Vejar's Location
Lafayette, California, United States, United States
Lindy Vejar's Contact Details
About Lindy Vejar

EXPERIENCE:A detail-oriented and results-driven program management professional with comprehensive technical expertise in medical device regulatory compliance, assay and systems engineering development, integration and product transfer. Experience through the entire life-cycle development process from early concept through technical transfer and successful commercial launch. Lead research teams and operations improvements to ensure maximum return on investments, customer satisfaction and overall financial corporate success.My focus is on people, process and projects that create sustainable business value and maintain high brand recognitionMy impact has been noted by consistently leading successful results driven cross functional and global teams to meet goals on-time and on-budget. SPECIALTIES:Collaborative Program Management supporting global Service, Marketing and Operations goalsChampion for high quality standards while improving gross marginStrategic operation’s planning and business analytic metrics developmentExpertise in FDA cGMP, GLP, design control and validationsProblem solver with data driven analytical approachesPromoter for Innovative thought and new ideas across business functionsSuccessful Business Excellence (Bex) Project implementations including: Design for Excellence (Dfx) and Design Capability Lean Six Sigma and process capability GOALS: To work with energetic and talented people in a global cross functional environment.To support products that benefits human health and advance quality of life.To make a difference in the medical device/biotech industry from idea concepts to post market improvements while maintaining high quality products and optimized global operations.

Lindy Vejar's Current Company Details
CM Health Systems

Cm Health Systems

View
MBA/Program Management/NPI/Manufacturing Engineering/Continuous Improvement/Lean Six Sigma Black Belt
Lindy Vejar Work Experience Details
  • Cm Health Systems
    Head Of Program Management
    Cm Health Systems Jul 2023 - Present
    San Jose, Ca, Us
    Working directly with founders to develop and implement business strategies around company's core competencies. Leading project teams to source and deliver medical and pharma innovative technology and equipment to developing and emerging markets to close gaps in access to healthcare. Initiating and running business development programs to improve sustainability and medical workflows with products and equipment in U.S. hospitals, military, veteran and student health applications. Work directly with start-up founders from initial concept through commercialization strategies and market access. Develop and manage companies KPI’s.
  • Cepheid
    Director, Program Management
    Cepheid Jan 2017 - Jun 2023
    Sunnyvale, Ca, Us
    Initiated and led high profile cross-functional teams in multiple departments to accelerate improvements where needed and align with corporate strategy. MEDICAL & SCIENTIFIC AFFAIRS 2022 -2023Reported to CMO, managed product, process, and compliance improvement initiatives. ^Led Fit for Purpose initiative to integrate DBS practices and roll MedSci team into PLM^Developed and oversaw Evidence Generation committee tracking a portfolio of >100 active medical, research studies including prototype instruments and assays in >30 countries.^Collaborated with Strategy team to develop competitive intel Obeya that was used as Danaher best practice showcase. Identified gaps in products to improve market competitiveness.INNOVATION CORE, 2019-2022 Reported through CTO, facilitated Innovation Leadership meetings, and led high profile innovation programs in early concept. Developed and tracked metrics and implemented countermeasures.^Led due diligence efforts for InSilixa acquisition to create Cepheid Biochip Business and ensure design transfer into GeneXpert platform. ^Led early-stage collaboration projects such as Rutgers, Johns Hopkins, UCSF, & FIND^Initiated grants with collaborates and tracked > $6MM in funded project^Led collaboration project with Hach Company and technology transfer for the GeneXpert water monitoring tool PMO | NEW PRODUCT DEVELOPMENT 2017-2019 Lead New Product Commercialization Teams and Improvement programs in Infectious Disease Diagnostic Group. Train and mentor new program managers. ^Created and directed Program Escalation Meeting-providing senior leaders with prompt and targeted weekly information.^Created and implemented finance tracking tools to visualize budget through the development process. ^Promoted and trained more than 100 Cepheid personnel on DBS PMO and Launch Excellence practices with kaizens and 4 bootcamps^Led and launched 4 new respiratory assays and new GeneXpert 10-color technology platform to successful launches.
  • Thermo Fisher Scientific (Life Technologies)
    Senior Program Manager, Product And Portfolio Management
    Thermo Fisher Scientific (Life Technologies) Oct 2014 - Jan 2017
    Waltham, Ma, Us
    Senior Program Manager, Program/Portfolio Management Office, Life Sciences Division, Lead New Product Commercialization Teams and Process Improvement programs in Genetic Analysis group. Accountable for program from idea through post-commercialization. Coach teams through financial models and reports, voice of customer evaluations, corresponding technical assessments, specifications, validation and commercialization requirements. Report progress, metrics and investment updates to Senior and Executive management to ensure programs realize corporate goals and strategy. Member of the portfolio review boards to ensure division is focusing on most value-added programs.^Drove successful assay development from early concept through launch strategies for new cancer and infectious disease programs on molecular test platforms. ^Led project portfolio team for Open Array product line during expansion and high growth period. Team was established to ensure the product line was successful to meet aggressive metrics. ^Evaluated and implemented new tiered portfolio management boards (KPI’s) for visual weekly achievements to senior leadership.
  • Abbott Medical Optics
    Senior Program Manager In Advanced Engineering
    Abbott Medical Optics Jan 2011 - Sep 2014
    Abbott Park, Illinois, Us
    Led service and operations activities for new product introductions from idea to post-commercialization to ensure reliable results in manufacturing operations and in the field. Led refractive R&D, operations and service teams on Design for Excellence (DfX), including cost of ownership financial benefits. Coached Business Excellence green belt projects to ensure financial success. • Led operations and service teams for the new generation Excimer laser improvements, and discontinued components for improved reliability and manufacturability by more than 50%. • Managed RoHS design transfer project for femtosecond laser team, including margin improvements and performance upgrade opportunities.• Initiated and taught Design for Manufacturing Assembly (DFMA) and design capability goals for division.• Conducted CAPA improvement initiative for manufacturing site to meet corporate standards.• Steered and led remote diagnostics project for four equipment project teams. • Led improvements on PCBA reliability and optics optimizations resulting in more than $1million in COGS savings.• Directed global operations and service teams on three upgrade projects and one recall initiative.
  • Bio-Rad Laboratories
    Senior Project Manager Ii - Bex Projects
    Bio-Rad Laboratories Mar 2010 - Jan 2011
    Hercules, Ca, Us
    Responsible for initiating and leading Business Excellence opportunities in Life Science Warehouse, Operations and Distribution departments. Required cross functional consensus among stakeholders including 66 Marketing Managers and more than 40,000 catalogue SKUsHIGHLIGHTED ACCOMPLISHMENTS• Identified more than $500,000 in COGS savings by optimizing packaging work flow and configurations in high mix low volume manufacturing operations• Promoted additional business benefits of packaging changes through customer experience, green marketing, brand recognition and sustainability initiatives
  • Bio-Rad Laboratories
    Senior Manufacturing Engineering Manager Ii
    Bio-Rad Laboratories Jan 2008 - Apr 2010
    Hercules, Ca, Us
    Managed manufacturing engineering groups at Nobel Life Science Manufacturing site. Supervised teams of scientists, engineers, technicians and documentation specialists. Developed and launched operational excellence training program for engineers and scientist. Reviewed and recommended facility and process upgrades in 925 Building and coached work centers through 5S practices. Implemented and trained staff on robust validation and documentation system. HIGHLIGHTED ACCOMPLISHMENTS• Evaluated and recommended efficiency and standardized systems, such as labeling, scheduling, packaging, manufacturing procedures and routings, to serve more than 10,000 product items.• Supported product improvements for consumable lines such as manual and automated electrophoresis and blotting, Bio-Plex Multiplexing and PCR reagents, sample prep kits and Bio-Education modules.• Led new product transfers into manufacturing; projects included long shelf-life electrophoresis gels and new Bio-Plex immunoassay panels.• Nominated by executive management to join the BEAD global innovation improvement team.
  • Bio-Rad Laboratories
    Site Manager - Hematology Diagnostic Controls Facility
    Bio-Rad Laboratories Apr 2006 - Jan 2008
    Hercules, Ca, Us
    Responsible for all site Operations including personnel, budgets, P&L, production schedules, and plant maintenance for Quality Systems Division (QSD) Hematology Controls Manufacturing facility.HIGHLIGHTED ACCOMPLISHMENTS• Managed gross sales of more than $11,000,000 with 250 master items and 50 permanent and contract employees. • Developed, implemented and managed facility improvement plan, including marketing and branding positioning, quality and regulatory improvements, and new product and product improvements. • Significantly Improved customer satisfaction and employee morale.
  • Bio-Rad Laboratories
    Mfg Engineering Group Leader
    Bio-Rad Laboratories 1999 - 2006
    Hercules, Ca, Us
    Managed cross-functional teams on expansion and lean projects in clinical reagents manufacturing. Supported product quality investigations, product launches and validation assignments. Supervised engineers and scientists. Member of FDA and TUV audit teamsHIGHLIGHTED ACCOMPLISHMENTS• Initiated and validated automated FFS packaging, resulting in $300,000 savings and improved quality.• Managed $600,000 year in savings, safety and efficiency projects in formulation operations. • Implemented and validated high-speed pharmaceutical for capacity expansion, reducing defects from 2.7% to Six Sigma levels while reducing labor by 30%.• Designed and managed component specification system for more than 800 materials.

Lindy Vejar Skills

Cross Functional Team Leadership Quality Assurance Product Development Medical Devices Validation R&d Quality System Quality Management Biotechnology Iso 13485 Process Improvement Operational Excellence Capa Business Process Improvement Continuous Improvement Project Management Lean Manufacturing Design Control Engineering Lifesciences Program Management Leadership Commercialization Software Documentation Manufacturing Engineering Pharmaceutical Industry Product Launch Spc Root Cause Analysis Process Simulation Design Of Experiments Team Building Technology Transfer Process Engineering Quality Auditing Biopharmaceuticals Change Control 21 Cfr Part 11 Regulatory Affairs Dmaic Regulatory Submissions Logistics V&v Clinical Trials Chemistry

Lindy Vejar Education Details

  • University Of California, Berkeley
    University Of California, Berkeley
    Chemistry
  • American Community School - Athens
    American Community School - Athens
  • University Of California, Berkeley, Haas School Of Business
    University Of California, Berkeley, Haas School Of Business
    General
  • Uc San Diego
    Uc San Diego
    Lean Six Sigma Black Belt

Frequently Asked Questions about Lindy Vejar

What company does Lindy Vejar work for?

Lindy Vejar works for Cm Health Systems

What is Lindy Vejar's role at the current company?

Lindy Vejar's current role is MBA/Program Management/NPI/Manufacturing Engineering/Continuous Improvement/Lean Six Sigma Black Belt.

What is Lindy Vejar's email address?

Lindy Vejar's email address is li****@****ast.net

What schools did Lindy Vejar attend?

Lindy Vejar attended University Of California, Berkeley, American Community School - Athens, University Of California, Berkeley, Haas School Of Business, Uc San Diego.

What skills is Lindy Vejar known for?

Lindy Vejar has skills like Cross Functional Team Leadership, Quality Assurance, Product Development, Medical Devices, Validation, R&d, Quality System, Quality Management, Biotechnology, Iso 13485, Process Improvement, Operational Excellence.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.