*** ****** ******

Watkinsville,Ga *****

Phone 334-***-****

E-mail acy8t9@r.postjobfree.com

LYNDON B. SALLIE, PMP

Objective

To obtain a responsible and challenging position that will utilize my leadership skills and engineering experience, and offer personal as well as professional growth.

Qualifications

Strong electro-mechanical engineering and design skills and the ability to work independently as well as within teams.

Experience with leading projects from initial concept, budgeting, through development and verification/validation testing, and into manufacturing.

Knowledge in manufacturing (processes, assembly, tooling, metal fabrication and machining).

Excellent leadership and problem-solving skills.

Excellent communication and customer interface skills.

Experience with strict regulatory and code agency compliance (IEC, UL, CSA, CE, RoHS).

Knowledge of Quality system requirements and industry practice (Good Manufacturing Practice). Participated in the AAMI course (Association for the Advancement of Medical Implementation), February 2013.

Experience with LEAN manufacturing concepts.

Knowledge of Microsoft Office Applications (Word, Excel, PowerPoint, and Project).

General knowledge of 3D CAD Modeling (AutoCAD, SolidWorks, PRO/E).

Experience

STERIS Corporation, Montgomery, AL 1992 – July 2015

Sr. Product Engineer, 2000 – July 2015

Performed a full range of engineering duties on a daily bases in a regulated medical device manufacturing environment.

LED design team for the design of medical devices to meet IEC 60601, IEC61010, GMP, ISO 13485, and FDA while following company quality procedures and new product development plan. Directed the designers and drafters to establish all drawings of all components and assemblies of the product.

Worked as Project Manager and product development engineer leading project team to enhance healthcare equipment and medical device products to meet customers and regulatory new requirements, as well as prevent loss of market share. The newly designed products resulted in customer satisfaction with new features, improved performance and reliability, and prevented loss of market share.

Worked as Project Manager and Engineering lead to transfer production of key components from an approved supplier, internally to STERIS manufacturing facility. The transfer of production resulted in creation of 80 new production jobs into the STERIS manufacturing facility, reduction in cost, and quicker response to service needs.

Developed and managed budgets up to $750,000.

Developed and managed schedules with timeframes up to 2 years and 4 months.

Ensured all project deliverables including contracts were completed on schedule.

Conducted weekly meeting with project team to discuss status of project, key deliverables, and assigned tasks.

Conducted design reviews with the stakeholders and sponsors at milestones throughout project lifecycle.

Establish qualification documentation (design specifications, device specifications, verification/validation test plans and reports, risk management files and assessments, Process Qualification (PQ), Installation Qualification (IQ), Operation Qualification (OQ), and Factory Final Tests). Write test protocols and summarize Engineering data to evaluate product performance in safety, durability, and life cycle testing.

Directed and/or implemented process development, procurement of tooling/fixtures, and identifying test equipment, test procedures, and testing process.

Experience

(Continue)

Write, review, and approve Engineering Change Notices to revise products.

Evaluate and analyze failed field components.

Performed root cause analysis for product and process failures, and implemented countermeasures to eliminate causes.

Implement and refine manufacturing processes by applying continuous improvement and lean manufacturing principles to areas of production.

Facilitate and conduct compliance testing with 3rd party compliance test laboratory.

Assist with procurement and supplier selection.

Participated in audits, investigations and tests. Evaluated internal and/or external manufacturing processes and technologies. Initiated and implemented improvement to those processes.

Supported compliant process, failure investigation, and Material Review Board (MRB).

Specified, identified, and justified approvals for purchasing capital equipment to support internal manufacturing processes and manufacturing processes in the supplier’s facility.

Provide technical support to Manufacturing, Sales, Marketing, Regulatory, Quality, and Service.

Manufacturing Engineer, 1998 -2000

Evaluated, developed, and maintained manufacturing process specifications in a regulated medical device manufacturing environment.

Interpreted engineer drawings/documents for manufacturing. Coordinated with CNC programmers, Tool & Die, Purchasing and any required subcontractors to produce components to meet project and schedule delivery dates.

Created and coordinated Bills of Materials (BOM), and other documents required to support manufacturing processes. Processed/implemented engineering changes and product documentation per established schedules.

Documented all processes using AS400 MRP system and applicable Standard Work Instructions formats.

Identified any tooling, fixtures, gauges, and test equipment needs as required to maintain production and essential quality requirements.

Performed product cost estimations and evaluations of alternative production methods.

Identified, evaluated, and performed Capital Equipment Justifications based on the needs of manufacturing.

Developed and maintained time standards.

Developed production layouts.

Product Designer, 1992 - 1998

Supported custom product development by modifying existing products insuring the modifications meets the customer, safety, and Regulatory requirements.

Prepared Engineering Change Notices to revise products.

Developed concepts and ideas.

Produced drawings using CAD system.

Provided technical support for special projects.

Education and Credentials

DeVry University - Atlanta, GA

Bachelor of Science in Electronic Engineering Technology

Project Management Institute (PMI), June 2016

Certification: Project Management Professional (PMP)®

Association for the Advancement of Medical Instrumentation (AAMI), February 2013

AAMI course (Quality Systems Requirements and Industry Practice)

Certificate of completion

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