Ivan A. Perez, PE, MBA

Urb. Munoz Rivera, ** Campo Bello St

Guaynabo, Puerto Rico 00969

787-***-****

vcrhtq@r.postjobfree.com

SUMMARY

Twenty years of experience in Manufacturing and Quality Assurance. Over fifteen years in medical device manufacturing. Experience in: product transfer; project management; process qualifications; development of qualification protocols; troubleshooting of manufacturing equipment and processes, including ultrasonic welding, ultraviolet (UV) light curing adhesives, assembly, packaging for sterile barrier, and bulk packaging. Process improvement expert.

QUALIFICATIONS

• Training Facilitator. Developed and conducted training to plant personnel on Statistical Process Control, Lean Manufacturing and Customer Supplier Relationship.

• Leadership. Lead multiple projects, activities, develop plans and interact with multiple organization levels.

• Completed a Masters Degree with a Major in Materials Management as a manner to sharpen the skills to find opportunities to improve manufacturing bottom line.

• Strong Project Management Skills. Participated as Project Coordinator (1 year assignment) for Process Improvement, with outstanding results: Savings $800 thousands, exceeding original estimates.

• People Skills. Performed as Production Manager on a temporary assignment for over 100 employees (3 month period); also as Production Supervisor for new projects until the release to production (various). Able to achieve production numbers with minimum overtime, minimum absenteeism and within budget.

• Process Expertise. No regulatory agency findings during audits to the processes and documentation under my responsibility.

WORK EXPERIENCE

2008 - 2010

General Manager/ Owner Villas Del Mar Restaurant, Inc., Maunabo, PR

Responsible for the overall restaurant operation. Supervise employees and contractors. Direct P&L and Facility Compliance Responsibilities. Owner since 2006.

• Maintained the restaurant operation over four years. Assisted in the development of a website to market the restaurant. Full compliance with the local and federal regulatory agencies. Interacted with customers, suppliers and employees. Reduced inventories, improving turns from 12 to 26 on the 80% higher value items.

1993 - 2008

Senior Manufacturing Engineer II Bard Shannon, Division of CR Bard, Humacao, PR

Project Manager/Technical Resource for Process/ Technology Transfers:

• Development of a Master Plan for the entire transfer. The plan has three phases; Phase 1, Sending facility documentation; Phase 2, Receiving facility pre-production documentation; and Phase 3, Validation run results and release to Manufacturing.

• Development of qualification protocols IQ/OQ/PQ/PPQ, for the equipment and processes.

• Adapt or create new operational procedures for the equipment, assembly methods, packaging, labeling and boxing of product.

• Conducted qualifications on critical equipment; sterile barrier package sealers, computerized label equipment, ovens. The challenges included as part of the qualification requirements were defined based on the intended function of the equipment and criticality of the product characteristic. Examples are:

• Process capabilities of seal integrity (Cpk); Security features of computerized systems; thermal profiles in compliance to operational ranges.

• Conducted training on the qualification document as well as the proposed operational procedures to the personnel related to the qualification runs. Also, supervise the runs until completed.

• Prepared a summary report of the qualification runs stating the results and its compliance to the initial requirement. Develop a conclusion to support the approval or rejection of the proposed equipment or process. In the event of failure, initiate a failure investigation protocol, develop test method and challenges, reproduce the failure, develop a control system, and challenge the system to verify its performance, and implement in the equipment, operational procedures and provide training before conducting new qualification runs.

• Lead Product/ Process Technology Transfer for several products: Centrifugal Blood Pump (1997); Access Systems Line Extension (1998-1999); 3D Max (2002); 3D Max Improvements and New Models (2003-2004); Urethral Bulking Agent (2005); Hernia Repair Product Line Extension and Improvements (2006); Fixation Device (2007-2008). Participated as Manufacturing Engineer (2000 to 2004) for other Hernia Repair projects lead by other Engineers.

Individual Contributor, Interaction with the R&D Group:

• The work with R&D requires building strong partnerships with colleagues far from each other. Constant communication was a key factor to keep the momentum in the fast paced work environment.

• During the transfer process, the Design Center from R&D provided support to gather data from Sending Facility. For about 70% of the transfers the Sending Facility was the process developers and the source of knowledge. The interaction included weekly meetings to review the progress and reach new commitments, and gain visibility of higher levels of the organization (up to VP levels and Worldwide Operations Director).

• Equipment/ Process Expert. Considered the Plant Expert for Leak Detection Test Equipment, Hernia Repair Manufacturing (70% of plant volume), Oncology Catheters (10% of plant volume), Electronic Documentation (approver for divisions Oncology, Urology, Hernia Repair, Vascular and Domestic). Back up for Facilities Manager function.

• Supervised Interns during a two year period. Also provided training to new hires on electronic documentation system, basics of Manufacturing Engineering, plant procedures and practices.

• Other projects leaded by the R&D group required plant support. Examples are CE Mark ready labeling, changes to include a medial mark on a Class III device (hernia repair implantable product). The initial development was made at R&D, and the final implementation took place at the Manufacturing site. Electronic files of label formats were received, stored and backed up, a qualification protocol developed, approved, then executed and a results report issued and approved The equipment related changes required a new layout to accommodate the new equipment, set up the required utilities, trial runs to develop a standard time, qualification protocols, execution, reports, and updating the product routing to include the new process and new procedures.

• Internal Quality Auditor during a period of five years. The task was supervised the Plant Compliance Officer, and focused to verify the compliance to the procedures and policies within the plant. The processes and documentation were verified against the approved procedures, and if nonconformity was found, a request for a corrective action was issued.

• Lead multiple cost improvement initiatives: Ultrasonic Slitting, with over $100 thousand (k) dollar savings; Leak Test Cycle Optimization, with a reduction of 48% of the cycle time of one third of the product volume, and the standard time improvement by adding a tester to gain advantage of combined operations (total savings $24 k); Non Sterile Packaging Improvement, reducing the material cost of the components by validating a cheaper product bag ( savings $20 k); Grafts Testability, a project to improve yield of product, by developing a new method and conducted the validation ($ 75 k); Efficiency Improvement Team (1996 and 1997) with overall plant efficiency improvements on 14% and 10%, respectively.

1992 - 1993

Quality Engineer Wheaton Plastics of Puerto Rico (Alcan Packaging), Cayey, PR

• Reviewed of Statistical Process Control (SPC) charts to verify, predict and take corrective actions as required.

• Developed a Quality Manual. At the beginning, the plant does not have a formal Quality System. To prepare the operational procedures, it was required to interview personnel, learned about the processes and harmonized the practice to the CFR guidelines, and then prepared a technical document in words adapted to the organization cultural environment.

• Reviewed and approved customer specifications. At the time a customer submitted their product specifications, the document was evaluated to confirm the plant can comply with the requirements, or proposed alternative until a satisfactory agreement was reached.

• Corrective Action Investigations. Discrepancies to procedures or to customer specifications were investigated to determine a root cause, and provided an immediate corrective action and prepared a plan for preventive action implementation.

• Training. Conducted training on new documentation, on SPC and all QE related subjects, to all applicable personnel.

• Conducted Awareness Meetings to Plant Staff to keep them informed about the Quality System status. Meetings included the monthly complaint trends, internal discrepancies, completed and pending corrective actions, Quality Manual status, among other subjects.

1991 - 1992

Manufacturing Engineer Pall Biomedical Inc., Fajardo, PR

Process monitoring during second shift operations.

1989 - 1991

Manufacturing Engineer Pamcor, Inc., Division of AMP Inc., Rio Piedras, PR

In charge of new machine improvement project. New layout for manufacturing operation, including packaging area. Duties as Industrial Engineer and Assistant Quality Engineer.

EDUCATION

2006 Universidad del Turabo

MBA, Materials Management Gurabo, PR

1990 Universidad Politecnica de Puerto Rico

BS, Industrial Engineering San Juan, PR

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