Project Manager

STEVEN WOLF

Fullerton CA, ***** **.**********@*****.*** 714-***-**** (C)

GROUP MANAGER/PROJECT LEADER

for PRODUCT SUPPORT

Senior Supervisor/Project Leader that solves complex problems or implements new or improved class II medical device products. Experienced with medical device post market support (customer complaints, CAPA, change control, manufacturing deviations/non-conformance, material review board). An effective communicator with Engineers, Quality Assurance, Manufacturing, Customer Advocates, and Business Managers. Enjoys helping others understand and solve their problems in order to meet company/project objectives.

Key competencies include:

CAPA Process (ISO 13485)

Failure Investigation Leadership

Quality Systems (FDA, 21 CFR 820)

Manufacturing Support (MRB/GMP)

Use of statistics

Design History File/Design Control

Risk Management (ISO 14971)

Design Transfer

Problem Solving/Six Sigma Tools/DAMIC

Process Improvement/Change Management

EXPERIENCE

BECKMAN COULTER, INC., Brea, CA 1980 to Aug 2013

(Manufacturer of clinical diagnostic medical devices)

Senior Marketing Specialist – Program management Jan 2013 to Aug 2013

(contract position). Assisting the manager of business development in advancing term sheets to executed agreements. Working with third parties (OEM) to update technical contract elements as required by due diligence process.

Senior Staff Development Scientist (2004-2011)

Project Leader to resolve company critical CAPA (Corrective and Preventive Actions) projects.

Determined root cause and created plan to correct Total Protein assay patient recovery issue in the United Kingdom.

Completed a failure investigation and created a new assay design to replace the Synchron Glucose assay that produced a product that eliminated all spectral interference issues for serum and urine samples.

Designed and implemented improved practices for Manufacturing Discrepancy Report resolutions and a formal failure investigation process.

Designed and implemented mitigation for a FDA audit finding for homogeneity testing/process validation in Manufacturing.

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Lead investigator of a hardware/photometer control board failure investigation and risk assessment.

Company trainer of the DAMIC problem solving process (Six Sigma)

Identified the root cause and designed/implemented a creative solution that resolved a CO2E assay on-board stability issue.

STEVEN WOLF page 2

Group Manager of the SYNCHRON Chemistry Group (10 members) responsible for line maintenance and assay product development.

Solved critical reagent and hardware manufacturing issues to maintain 100% production shipments/no stock-out situations for three years

Developed group members into companywide recognized product experts

Redesigned the chemistry job titles/pay scale that improved employee retention

Supervised the development of a new amylase assay that reduced the total product cost by 50% and an improved HbA1c product that always meets certification requirements

Lead Chemist on the Project Leadership Team to develop the company’s next major product line

Implemented a new development process to produce customer centric product definition/project vision and system requirements

Demonstrated how an Engineering approach for FMEA (Failure Modes and Effects Analysis) is adaptable to a chemistry product

Design concept generation/analysis

Staff Scientist (2000-2004)

Chemistry Subject Matter Expert/consultant for the SYNCHRON DxC Project team

Project Leader for product re-standardization projects

Defined/created Software/Chemistry System Requirements for the algorithms used to produce sample results and quality error checking and guided/contributed to the Team resulting to the on-time product release

Managed the project that standardized five enzyme assays to the IFCC 37 C reference procedures (AST, ALT, CK, GGT, LD) and met European customer needs per schedule goals.

Project Leader that standardized four creatinine assays to the IDMS (Isotope Dilution Mass Spectroscopy) reference procedure and met the NKDEP (National Kidney Disease Education Project) performance standards

Project Scientist (1993-2000)

Chemistry Lead for the SYNCHRON LX20 System project

Planned and managed resources of the Systems Integration Team (15 members, 5 direct reports) that launched 40 assays and the instrument per the project target dates

Supervised the development of three enzyme assays designed to the IFCC 30 C reference procedures (AST, ALT, CK)

Multiple titles: Scientist (1980-1993)

Supervisor for 5 scientists responsible to resolve Manufacturing issues for 35 assay products for the SYNCHRON CX product line.

Transferred 35 reagents to Manufacturing for the SYNCHRON CX product line. Developed the uric acid, phosphorus, iron, magnesium, gamma-glutamate transferase, alkaline phosphatase products.

EDUCATION

Masters of Science, Organic Chemistry, University of Nevada Reno

Bachelors of Science, Chemistry, University of California Santa Barbara

PROFESSIONAL AFFILIATIONS

Member of the American Association for Clinical Chemistry (AACC) 1982 - 2011

Joint Committee for Traceability in Laboratory Medicine (JCTLM) (2005-2011) Working Group 1, Review Team for Enzymes and Review Team for Metabolites and Substrates

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