David Raymond Schinhofen

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

Brunswick, ME 04011

207-***-****

adsmdq@r.postjobfree.com

P R O F E S S I O N A L S U M M A R Y

Customer focused engineer with exceptional expertise in the validation and support of diagnostic testing. Proven success working with R&D stage gate processes, transition of product to market, and support of released product. Demonstrated ability to promptly adapt to a diversity of roles valued by the organization. Distinctly qualified to realize manufacturing operations and business objectives by supporting process improvement, product reliability and customer satisfaction initiatives. S T R E N G T H S

• Expertise in Biotechnological Product Engineering

• Project Management

• Design and Process Verification and Validation (V&V)

• Data Analysis/Application of Statistics and Six Sigma Methodologies P R O F E S S I O N A L E X P E R I E N C E

IDEXX Laboratories

Westbrook, ME

SENIOR PROCESS ENGINEER

• Ran lean project team. Rapid improvement project decreased queue time by 20%, eliminated 12 touch points, and cut five steps out of the physical movement of material.

• Routinely analyzed and reported manufacturing and product performance metrics.

• Developed standard operating procedures for risk assessment and verification testing. SENIOR PRODUCT ENGINEER

• Led the development of an OEM imaging system and software for a bilateral flow device. The project met metrics including an aggressive cost target $900 per instrument, $17M EVA, and less than 2% service events in the first year of production.

• Developed test plans for verification and validation of hardware integrating point of care diagnostics. Elements of the test plans included protocols for requirements verification, software regression, method comparisons, and process qualification.

• Led program chartered to develop test fixtures calibrating optical subsystems. The successful implementation of the methodology resulted in 400K per year in consumable cost savings and reduced the standard calibration processing time from 45 minutes to 8 minutes.

• Successfully increased manufacturing FPY of a calibration operation from 70% to 98% resulting a cost savings of $250K per year, and improved RTY. Improvement was developed through data analysis and testing which demonstrated some release criteria was too stringent or non-value added. RESEARCH ASSOCIATE IV

• Managed the verification and validation testing of a blood gas and electrolyte analyzer for veterinary applications. V&V included software verification, precision studies, and method comparison performance validations.

• Completed R&D feasibly, concept, and development phases for the veterinary application of the Urine Protein Creatinine ratio. Product in release increased the value of the product platform to the customer base, resulting in a gain of 5% of market share over the competitors.

• Developed protocols and validations for material, design, and software changes in support a laser- based hematology analyzer.

• Provided routine laboratory support including maintenance, QC, and preparation of biological materials. YSI, Incorporated

Yellow Springs, OH

PRODUCT ENGINEERING CHEMIST

• Successfully scaled up the production of a proprietary method of isolating and purifying an enzyme by transferring the process to an outside supplier.

• Developed product specifications for consumable products based on customer requirements, research of relevant literature and published diagnostic practices.

• Manufactured cellulose acetate material with characteristics developed for increasing the rejection of compounds interfering with sensor response.

• Developed a method to characterize polycarbonate porosity by measuring air flow rate which enabled the predictive output of the manufacturing process.

• Reformulated a consumable buffer using DOE methodology in response to reports from the customer base that the product was susceptible to microbiological growth and was not meeting the specified stability requirements.

• Published a table documenting the effect of pharmaceutical compounds in human biological fluids on the interpretation of diagnostic results.

Additional Positions Held:

• Quality Control Chemist

• Manufacturing Chemist

• Research Scientist II

R E L E V A N T T R A I N I N G

Certifications:

Certified in Project Management: Worcester Polytechnic Institute Certified in Agile Project Management: University of Southern Maine IDEXX EXCELERATE Management Program (15 Month program)

• Coaching Essentials

• Building Trust

• Clarifying Team Purpose

• Difficult Interactions

• Giving Feedback

• Time Management

• Change Management

• Decision Making

• Persuading Others

• Team Management

Training in Statistical Problem-Solving Methodology: Six-Sigma (IDEXX Five-X Program)

Statistics

Measurement Systems Analysis

Y-X Approach for Problem Solving

Design of Experiments

Graphical Presentation of Data

E D U C A T I O N

Antioch College

Yellow Springs, Ohio

BACHELOR OF SCIENCE IN BIOLOGY

Senior Project in Analytical Chemistry: Comparative Analysis of Immobilized Enzyme Technology to HPLC for the Determination of Aspartame Concentration in Beverages

• The project characterized the shelf life of aspartame in targeted product matrices. The stability of aspartame was characterized by correlating the expected concentration of aspartame to the measured concentration as a function of time and temperature. C O M M U N I T Y E N G A G E M E N T

Environmental Commission: Yellow Springs, OH Village Council Chaired commission

• Evaluated and implemented residential water conservation program and net billing for electrical service.

• Facilitated public forums between residents, industry, and the Ohio EPA regarding detectable levels of hazardous compounds in local ground water.

Brunswick Topsham Land Trust: Brunswick, ME

Supporting Member and Volunteer

Brunswick Parks and Recreation: Brunswick, ME

Volunteer

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