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Medical Device Process Validation

Location:
Hillsborough, NJ
Posted:
April 02, 2024

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Resume:

Rudolph Wolf

** **** *****

Lebanon, NJ *****

908-***-****

SUMMARY:

● Process Engineering professional with experience in fast paced medical device manufacturing environment.

● Experienced in LEAN manufacturin

● Extensive experience in process validation and equipment qualification for medical device manufacture.

● Validated manufacturing processes per ISO 13485. Education:

● Rutgers the State University of NJ, New Brunswick, NJ 1988-1994 MS Ceramic Science

● Pennsylvania State University, State College, PA 1980-1984 BS Ceramic Science and Engineering

Certifications:

● Process Validation Principles and Protocols – Oriel STAT A MATRIX

● Internal Auditor Training for ISO 13485 – Oriel STAT A MATRIX

● Minitab Essentials, Factorial Designs and Statistical Quality Analysis – Minitab LLC

● Autodesk Inventor Introduction to Solid Modeling – IMAGINiT Technical Training Services

● Excel Advanced – Corporate Training Group

Skills:

● Minitab statistical software

● MS-office suite (Excel, Word, Outlook, Powerpoint)

● SAP

● LIMS (LabsQ)

● QIM (software for quality issues)

Core Qualifications:

● Process Validation and Equipment Qualification

● Materials characterization

● Adhesive assembly and automated equipment for adhesive assembly and packaging

● Process trouble shooting for LEAN manufacturing and OEE improvement

● Vacuum induction and air melt alloy processing

● Ceramic technology – powder processing, slip casting, sintering and controlled atmospheres.

● Refractory selection, structure design and application

● Excellent Project management skills

Experience:

Ivoclar Vivadent Manufacturing Somerset NJ

Process Engineer III

July 2013 - Present

● Adhesive assembly of dental ceramic CAD/CAM materials.

● Responsible for automated and manual adhesive assembly processes.

● Familiarity with UV curing adhesives, epoxies, and other materials used in an ISO13485 medical device manufacturing environment.

● IQ/OQ of automated adhesive assembly production equipment.

● Qualification of industrial label printers for electronic planning and production control (ePPC) workplace.

● Qualification of US vendor for precision machined component of ceramic CAD/CAM block value streams (6M pieces/year).

ALCOA Howmet Dover Alloy Dover NJ

Process Engineer

August 2009 – July 2013

● Responsible for materials optimization of melt crucibles, tundishes, ingot molds, and other refractories used in production of nickel and cobalt based super alloys.

● Familiar with vacuum induction melting, AOD refining and continuous casting.

● Obtained AS9100 internal audit certification.

● Supervised refractory team during monthly re-lining of induction melt crucibles.

● Inspection of refractory lining to extend service.

● Interpretation of metallurgical analyses (optical emission, mass spec, Leco carbon and sulfur).

● Reduction, recovery and characterization of scrap for remelt.

● Testing of new refractory materials for melter bricking, tundish assembly, hot top and insulation.

● Inspection and repair of induction coils.

Morgan AM&T, East Stroudsburg, PA and Kingston ON Canada Project Engineer.

March 2008 - December 2008

● Manufactured ceramic products for molten metal foundry applications and ceramic armor.

● Slip casting of technical ceramics.

● Mold design.

● Technical ceramics sintering.

Tiger Optics, Warrington PA

Technical Service Engineer

October 2007 to February 2008

● Technical service for Tiger Optics PPB gas analyzers.

● Technical service for MEECO flammable gas analyzers. BOC Gases, Murray Hill NJ

Staff Scientist

February 1988 to March 2007

● Pilot processing and characterization of proprietary adsorbent and catalyst materials.

● Co-inventor US Pat.#7070752 and #6358302.

● Operation of controlled atmosphere furnaces, screen printers, and circuit assembly equipment.

● Planned and executed experiments and customer demonstrations.

● Designed and fabricated chemical synthesis system for aluminosilicate zeolite molecular sieve materials.

● Used industrial soldering equipment to test controlled atmospheres for IR reflow furnaces.

● Porosity measurement for proprietary non-cryogenic air separation materials (N2 BET).



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