Samuel A. Linder

**** ********* **., ******, ** *9150, USA

Phone: 803-***-****, Mobile 864-***-****

Email: adeya6@r.postjobfree.com

Senior Mechanical Engineer

Career Summary

Mechanical engineer with +10 years’ experience in project management, product development and R&D in RFID, film, paper and plastic converting, medical device, semiconductor, automotive and textile industries. Experience with ISO 13485 and FDA QS Regulation Part 820.

Skills

Proficient in ISO and ASME drawing standards and tolerances, reading mechanical prints and electro schematics, AutoCAD, material strength and application, validation, MS Word, Excel, Visio, PowerPoint, Project Management, procurement of parts and equipment, hands-on troubleshooting.

Familiar with Solidworks, automation and controls, PLCs, hydraulic and pneumatic, machine safety (ISO9001 & OSAH), material coatings and surface finishes, vendor management and TQM.

Hands-on with heavy equipment, fast assembly of minute parts, repairs, line rebuilds and CI.

Professional Experience

Becton, Dickinson and Company - Sumter, SC, USA 2014 - 2017

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.

Senior Mechanical Engineer

Oversaw and sustained the capacity and quality of high speed manufacturing lanes producing Medical Devices, hands-on trouble shooting and machine improvements.

Improving OEE by 15% in FY15, and best performing lines in FY16,

Process and Continuous Improvement, Cost reduction with Lean Six Sigma and 8-D

Supervised, guided and inspected work in progress of vendors, contractors, engineers and technicians, restructured machines to optimize operation and teamwork

Lead & planned capital projects & capacity expansions with production support 24/7

Procured, installed, tested and validated equipment and components

Trained associates in operation, quality and safety; cGMP, GDP, TQM, UDI, OSHA

Redesigned machinery and parts to reduce MTBF and enforced PM to improve MTTR

Supported QA in TQC, CAPA, DHF, DMR, DHR filing.

Maetrics LLC - Indianapolis, IN, USA 2013 – 2014

Maetrics is a full-service, professional consulting firm for FDA regulated industries; developing and implementing compliant, sustainable best practices that will withstand regulatory scrutiny.

Sr. Compliance and Quality Engineer

Consulting worldwide customers in the compliance with US Food and Drug regulations as well as Canadian, European, and ISO requirements.

Pre-inspection Audits, Facilities & Equipment Legacy Reviews

Process validation and documentation reviews and FDA 483 remediation.

Assess Risk Management Documentation according EN ISO 14971, CD 93/42/EEC and CD2007/47/EG

Remediation of manuals, WO, DHR and reports.

Graf Metallic of America – Spartanburg, SC, USA 2013

Graf is a worldwide leader of innovative metallic card clothing, flexible flat clothing and stationary flats for the textile industries.

Shop and Field Service Supervisor

Responsible for the daily workflow in the shop and planning of the service engineers. Design of new products and repairs, cost calculation and purchasing.

Haemonetics Corporation – Union, SC, USA 2008 – 2013

Haemonetics is a global corporation and manufacturer of automated blood processing systems and pharmaceutical IV-solutions with $600 MM in annual sales.

Manufacturing Engineer

Managing capital projects, implementing processes and products, procurement and installation of new equipment, documentation and IQ/OQ/PQ qualification under FDA and ISO 13485.

Defined, installed and maintained equipment and processes associated with a state of the art pharmaceutical manufacturing plant. Seamless integration of such with 100% production goals met on the first day of operation.

Expanded plant capacity and capability to meet demands, changed HMI – PLC controller on Steam Sterilizer. Increased manufacturing capability by 70% within existing floor space.

Implementation of Lean Manufacturing; Developed and installed JIT process. Increased and maintained process OEE’s of NLT 80%.

Trained and controlled personnel in plant regulatory compliance including DHEC, EPA, FDA, OSHA and ISO through continuous adherence to cGMP standards.

Installed and maintained security and surveillance system to improve work safety.

Good communication, interpersonal, problem solving, negotiating, prioritization, and organizational skills.

Avery Dennison Corporation - Clinton, SC, USA 2002 – 2007

Avery is a worldwide manufacturer of consumer products, pressure-sensitive adhesives and label materials with annual sales of $6 Bil.

Manufacturing and Process Engineer

Responsible for research and development of products and processes to manufacture RFID devices, so called “Chip to Film and Paper”, including evaluating worldwide chip bonding and converting equipment and technologies.

Managed the purchase, qualification, installation and validation of machines and systems.

Evaluated, analyzed and developed new processes to assemble interposer modules onto RFID antennas, convert them into inlays and labels applying Flexo and Rotogravure printing, slitting, rewinding and editing of labels and tags.

Developed new manufacturing process for RFID devices, improved the performance of the flip chip machines from 4500 to 19000 UPH, and new rapid prototyping cell to reduce lead-time from 45 to 15 days.

Trained personnel in TQM and ISO-ANSI standard dimensioning.

Continuous improvement of product and processes applying VA/VE methodology and Lean Six Sigma, improving the quality be 10% respective $6MM yearly.

Tracked and analyzed IP and initiated patents.

ESEC-Sempac SA - Cham, Switzerland (now BE Semiconductor Industries) 1995 – 2001

ESEC was a $200 MM company manufacturing highly automated bonding equipment for the semiconductor industry.

Project Manager

Designed and developed new products and processes for Semiconductor Packaging and Injection Molding of MMC, SIMs, Smartcards, and RFID. Developed tools and automation for plastic-injection (with in-mold assembly, labeling, thin-wall, 4 cavity hot-runner) and transfer molding machines, specifying, purchase, implement, test and install of tools and production equipment (hydraulic presses). Led quality and design reviews with tool makers. Designed lead frames and plastic parts using CAD and FEA tools, formulated manufacturing procedures and quality standards.

Reviewed and analysed IP. Applied for and received several patents.

Developed processes to manufacture plastic molded electronic parts with less production steps and cost saving of 30% for medium lot sizes and faster time to market.

Explored and reduced deformation of molding tools by 50%.

Defined the life-cycle, toll-gates and led the team to successful ISO-9001 certification.

Determined and applied environmental standards to keep the yields above 97%.

Organized and managed the customer service department with four service engineers supporting customers worldwide.

Worked with AutoCAD, Solidedge and ProE.

Sulzer Textile AG - Rüti, Switzerland (now ITEMA) 1991 – 1995

Worldwide active textile machine manufacturer with $300 MM sales

Supervisor Engineering & Development - Rüti, Switzerland

Managed the development group for Air Jet Weaving Machines, defined goals, deadlines procedures and planned resources. Led development projects and tests in cooperation with Toyoda Automatic Loom Works, Japan. Reviewed and analyzed all drafts, design changes, patents and IP initiated by Toyoda.

Supported the CSS group with the development of new components and its tests.

Reduced the vibration of machines and components by more than 70%.

Reduced the development cost by 75% applying VA/VE methodology.

Implemented QSI/SQS according to ISO 9001 and trained employees in it.

Education

Project Management, Lean Six Sigma, 8-D

BS Degree - Thermodynamic and Mechanical Engineering,

Zurich University of Applied Sciences – Winterthur, Switzerland

AS Degree and Apprenticeship - Technical Drafting and Machine Design,

Berufsschule Sulzer – Winterthur, Switzerland

Organizations and Professional Affiliations

ASME – American Society of Mechanical Engineers,

SASP – Swiss American Society of the Piedmont, Past President

Patents Published

US Pat 7874493, US Pat 7555826, US Pat 7224280, TW 475246, EP 1111540, EP 0296114

Languages

Fluent in English and German, knowledgeable in French, Italian and Spanish.

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