Product Development, Project Manager, Operations Manager, Manufacturing Supervisor and Consulting Engineer with more than 10 years of experience in a variety of industries, including Medical Device, Pharmaceutical and Telecommunication. Diverse, comprehensive Operational background, including Manufacturing, Quality, Engineering, Supply Chain/Sourcing, Logistics, Strategic Planning, and Marketing.
Project planning and development
Lean manufacturing and design
Advanced problem solving
Dedicated team player
In-depth OSHA knowledge
Exceptional organizational skills
Microsoft applications skills
Budgeting and finance
Strong verbal communication
Client assessment and analysis
Risk management processes and analysis
Product Development Manager01/2004
to 05/2013 Stryker Medical Device – Arroyo,
Led two Manufacturing Transfer project in parallel (Disposable Cuff Capacity Increase, Dual Bladder Cuff and Reusable Cuff Manufacturing Transfer implementation.
Directed all phases of Reusable Tourniquet Cuff project, from Planning to Close-out Phase.
Developed weekly executive presentations and reports to facilitate project evaluation and process improvement.
Directed planning, budgeting, vendor selection and quality assurance efforts.
Supervised the work of 4 team members, offering constructive feedback on their work performance.
Defined clear targets and objectives and communicated them to other team members.
Monitored timelines and flagged potential issues to be addressed.
Coordinated design meetings and decisions across 7 internal departments and teams.
Reviewed sales, customer concerns and new opportunities to drive business strategy at weekly planning sessions.
Implemented a set of comprehensive tracking processes to monitor Dual Bladder and Reusable Tourniquet Cuff Project performance.
Directed quality assurance efforts to maximize product quality and minimize complaints.
Assessed vendor products and maintained positive vendor relations.
Collaborated with the Manufacturing business unit department to achieve zero backorder goal.
Implementation of New Manufacturing Transfer Corporate procedures on March 2012. Backorder reduction of 592K.
Successful implementation of Reusable Tourniquet Cuff Manufacturing Transfer Project on December 2012. Project ended within budget (+42K).
Implementation of Tourniquet Cuff Accessories CAPA.
42 % of complaint reduction.
Associate Unit Manager01/2008
to 09/2011 Stryker Medical Device
Managed 2 Manufacturing Business Unit with annual COGS of $56M employing 240 operators.
Supervised a team of 12 direct reports.
Conducted Capacity Analysis needed to reduce 14M of backorder.
Established control plan to reduced overtime, labor variance, accident rate, complaints and scrap.
Established and maintained more than 10 vendor partnerships.
Led initiatives such Value Stream Mapping, Kaizen Events to improve the efficiencies of the business units.
Established operational objectives and work plans and delegated assignments to subordinate direct reports.
Completed 12 performance reviews each year, offering praise and recommendations for improvement.
Completed and offered Business Unit reviews in a monthly basis to Director and Managers of the company.
Managed Capacity Increase validation activities (re-layout and line rebalance) resulting in a reduction of 14M of backorder.
Successfully implementation of Lean initiatives (Picture Process Mapping procedures, Standardized work and One piece flow).
Reduced accident rate by 67%.
8 Continues Improvement projects were implemented resulting in 58% of CPM (Complaints per Million) reduction.
Direct staff engagement (Q-12) of 4.75
28% of labor variance reduction.
326K of scrap reduction.
Overtime reduction from 17% to 5%.
Product Availability of 99.8%.
Validation Specialist Contract position with Wyeth Pharmaceuticals and Cardinal Health01/2003
to 01/2004 M & T Engineering Services – Las Piedras,
Developed validation master plans, process flow diagrams and test cases.
Analyzed validation test data to determine whether systems or equipment have met validation criteria or to identify root causes of production problems.
Identified deviations from established product or process standards and provided recommendations for resolving deviations.
Participated in internal or external training programs to maintain knowledge of validation principles and industry trends.
Prepared and/or reviewed validation and compliance documentation, such as engineering change notices, schematics, or protocols.
Studied product characteristics or customer requirements and conferred with management to determine validation objectives and standards.
Designed validation study features, such as sampling, testing, or analytical methodologies.
Assisted in training equipment operators or other staff on validation protocols and standard operating procedures.
Coordinated the implementation or scheduling of validation testing with affected departments and personnel.
Conducted validation or qualification tests of equipment in accordance with internal protocols or external standards.
Created, populated, or maintained databases for tracking validation activities, test results, or validated systems.
Resolved testing problems by modifying testing methods or revising test objectives and standards.
Prepared detailed reports based on results of validation and qualification tests.
Successful implementation of Packaging Equipment validation on time and within budget.
to 01/2003 Lucent Technologies – Hato Rey,
Developed, managed, and implemented project schedule for specific geographic/market area.
Engaged internal and external project resources.
Managed the project to meet site business objectives.
Drove network deployment performance to meet project schedule objectives.
Tracked and reported project dates, status, and actions weekly.
Developed and implemented project slip mitigation actions.
Coordinated site walks.
Managed / coordinated field technical resources to meet site milestones (microwave acceptance, technical equipment installation, commissioning, and optimization.)
Drove creative solutions for extra-ordinary challenges.
Coordinated all the activities with the Integrations Services vendor, RF, Operations, and Network Finance.
Led expedited implementation under the pressure of very tight deadlines.
Successful implementation of wireless network capacity increase project.
to 12/2007 Stryker Medical Device
Evaluated & revised production work instructions for assembly and inspection personnel.
Developed and wrote Quality Alerts and distributed to the production teams on each shift.
Established & maintained Boundary Acceptance Standards for sub-components & finished goods to comply with customer quality expectations.
Provided Quality Awareness to operators in order to discuss customer rejects & help prevent recurrence.
Processed and evaluated customer returned goods and issued RGA's (Returned Goods Authorizations) as appropriate.
Conducted failure analysis of product and process, problem solving, reliability design improvements, product failure trending and training.
Contacted & worked with component suppliers to addressed any quality issue. Supported them to develop and standardize inspection methods and/or techniques to ensure components compliance with specifications.
Provided weekly feedback to management regarding defect trends both internal and external.
Conduct internal and external audits.
Provided training to operators in Quality Assurance/GMP/FDA-QSR related topics.
Designed and/or implemented methods and procedure for inspecting, testing, and evaluating precision and reliability of products and/or production and/or test equipment.
Stopped further processing in the event of encountering non-conforming products condition.
Prepared documentation for inspection/testing procedures.
Supported vendor management issues: Problem solving, Auditing, Inspection techniques/equipment and training.
Interacted with customers to solve reliability issues and/or answer general product questions. Complaint investigation, problem solving and reporting.
Assisted during new product development, validation support for product, processes, packaging, software and sterilization.
Coordinated the activities of one or more Quality operators and/or technicians.
16% of reduction in internal Non-Conformance reports (NCR).
Participated in FDA and ISO audits resulting in Zero major observations.
Led 2 CAPA's (Corrective Action/Preventive Action) projects resulting in complaints reduction.
Quality Award recognition and Employee of the month.
to 12/2005 Stryker Medical Device
Successfully managed production activities of 10 different production lines so all orders were shipped on time.
Prioritized production schedule based on product, equipment, material, operators variables with the assigned area.
Investigated and implemented ideas for quality improvement, increased productivity and cost reduction.
Championed quality initiatives.
Managed documentation of and training on production procedures and work instructions.
Maintained and communicated daily productivity and shipment reports for all departments.
Verified that all process control parameters were being documented and followed at all times.
Immediately addressed all expired product dispositions.
Procured required manufacturing equipment and parts.
Planned, directed, coordinated and assigned operators to meet aggressive production schedules.
Defined manufacturing performance standards and reviewed the outcome of performance goals to set future targets.
Created and updated department work instructions and reports on a regular basis.
Addressed all personnel issues promptly and professionally.
Drove daily production activities with effective communication and leadership.
Directed improvements in safety, product quality, service and cost efficiency.
Directed the manufacturing process to achieve goal of first run capability.
Worked with quality manager to achieve the proper segregation and recycling of all product hold and rework.
Completed and recorded all recycling and rework documentation with a high degree of accuracy.
Supported the development of operators to meet competency and performance expectations.
Escalated safety and quality issues and initiated remedial actions promptly.
Completed and maintained accurate and organized records, documents and reports.
Completed performance evaluations on time.
32% of reduction on complaints.
94% of Pitch attainment.
Poople engagemet of 4.10.
Bachelor of Science: Mechanical Engineering1999University of Turabo-
Training / Certifications
New Managers Training Leadership Academy Project Management Professional (PMP) Training.
Decisive leader/team player who effectively managed projects, cross functional team and/or multiple priorities under the pressure of fast-paced, time sensitive environment.
Highly customer service orientation.
Computer-literate performer with proficiency in Windows operating systems and software including Word, Excel, PowerPoint, Outlook, Project, Trackwise and Agile.