Engineer Injection Molding

Phone: 909-***-****

Email: ******@*******.***

***** ********** **.

Fontana, Ca.

John R Kniffin

Summary A results oriented Engineer with 27 years experience in the

medical device manufacturing industry and 5 years

experience in the custom injection molding industry.

Experience includes process development, manufacturing

support, facilitation of continuous improvement teams and

injection molding of engineering thermoplastics.

Proficient in DOE, data analysis, SPC, and lean

manufacturing concepts. Major strengths are in process

validation with emphasis on ISO and federal CGMP

compliance.

Experience

2007 - 2011 Advanced Bionics

Sylmar, Ca

Manufacturing/Validation Engineer

Executed many process validations from laser marking

processes to gold wire winding processes, including all

documentation to satisfy FDA requirements.

Validated a LIM (Liquid Injection Molding) process for an

eight contact paddle lead component used in an implant pain

management system.

Major engineering support for manufacturing of electrode

sub assembly for cochlear implant.

Improved assembly yields from 80% to 92% for electrode sub

assembly by implementing improved fixtures and developing

focused operator training programs.

Led cross functional teams to perform root cause analysis

and implement solutions to quality and productivity

issues in conjunction with company CAPA system.

2001 - 2007 Inland Technologies

Fontana, Ca

QA Manager

Facilitate customer and ISO Quality Management System

audits.

Successfully managed upgrade to ISO 9001:2000 and

acquisition of ISO 13485:2003 certifications.

Heavy interface with customers on quality issues.

Reduced customer complaints/returns by 50%

Facilitated cross functional teams using RCA to determine

effective cause and corrective actions in response to

customer complaints and internal MDR's.

Manage a staff of 12 inspectors, 2 document control clerks,

1 first article inspector and 1 quality engineer.

1993 - 2001 Mallinckrodt Medical

Irvine, Ca.

Project/Manufacturing Engineer

Optimize molding processes to improve yields and

productivity utilizing DOE to identify significant process

inputs.

Evaluate molds for process capability (CpK) during

development phase. Recommend and coordinate tooling

modifications using internal and external resources.

Perform process Validations including the preparation of

test protocols, reports and data analysis to satisfy CGMP

and internal regulatory requirements.

Provide technical support and troubleshooting skills to

manufacturing to achieve objectives for safety,

productivity and quality

Participate in the company Quality Improvement Process by

leading and facilitating cross functional teams using the

Juran Quality Improvement Process.

MAJOR ACCOMPLISHMENTS

Eliminated assembly cracking problem by optimizing molding

process for a polycarbonate component.

Eliminated excessive process adjustments, by technicians,

by optimizing processing parameters and providing the

necessary training and documentation to assure

repeatability between set-ups.

Managed the installation, qualification and validation of a

MOTAN central resin delivery system.

Managed project to fabricate and validate 4 automatic inner

cannula molds resulting in an annual savings of 1 million

dollars.

Member of project team to relocate two Mallinckrodt molding

facilities into one new location in Irvine Ca.

Lead cross functional team to design, manufacture and

introduce into the market a fenestrated inner cannula to

compliment an existing product line. Major tasks included:

Product design and specifications

Process development

FMEA

Creation and maintenance of DHR.

1976 - 1993 Iolab Corp. div. of Johnson

& Johnson Claremont, Ca.

Process Engineer Manufacturing/Research & Development

Developed tumble polishing process for single and multi

piece Intraocular lenses.

Developed dry tumbling process for the finishing of

polypropylene intraocular lens haptics. US patent No.

4,551,949 awarded.

Design of jigs and fixtures to reduce variation in operator

dependent processes.

Initiated the use of control charting to identify and

correct process and/or operator related problems.

Automated micro drilling operation to eliminate operator

variability.

Perform process validations and manufacturing support as

described earlier.

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