Daniel F. Zeilermeir

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

Crystal, MN 55428

763-***-****

acw87i@r.postjobfree.com

PROFESSIONAL SUMMARY:

Highly motivated and energetic Business and Engineering Professional looking for career advancement. The question is “What can I do for you?” Results driven by leveraging experience, strategic thinking, education, communication, foresight, confidence, wisdom, and a passion for work are some of the tools I can bring to your organization.

https://www.linkedin.com/in/daniel-zeilermeir-mba-32515719

EDUCATION:

EXPERIENCE:

NPI

DOE

Agile

PMP

GMP, GDP

Project Management

CAPA/NCMR

V&V

QMX/Windchill

GIT, SDLC

Validation

Calibration

Process Optimization ISO 14001, 13485, 14971

Process Development

Failure Analysis

SolidWorks

Fabmaster

Microsoft Office

Root Cause Analysis Pneumatics

LabView

MBA (Masters Business Administration)

University of Northwestern - St. Paul – 2014-2016 (4 yr.) GPA 3.95

BA (Organization Leadership)

Bethel University – 2012-2014 (4 yr.) GPA 3.79

Associates (Electronic/Electro-Mechanical Technology)

Chippewa Valley Technical College - 1988-1990 (2 yr.) GPA 3.23

St. Jude Medical

177 East County Road B, St. Paul, MN

Senior Technician, Mfg. Production Admin. (1/2015 - Present)

Senior Mfg. Technician – Process Engineering (1/2014 – 1/2015)

Senior Mfg. Technician – Process Development (3/2013 - 1/2014)

Manufacturing Engineering Technician II (3/2007 - 3/2013)

Manufacturing Technician (7/2005 - 3/2007)

Electro-Mechanical Maintenance Technician (12/2003 -7/2005)

Project Management:

Identifies critical personnel, gauges, procedures, and materials needed for the completion of new processes and products

Professional communication in an effective and timely manner with internal employees, vendors, management, the sales force, and medical professionals

Negotiating target completion dates with personnel from other departments

Developing project plans and schedules for work activities

Creates project plans, implementation strategies, and execution plans

Project planning for CI Projects, Facilitating, and Leading to Closure

Medical Device:

Adhere to QSR/ISO regulations, DA, FMEA, and product testing methods

Interpret and apply FDA regulations to business practices and provide input, advice, and guidance to project and the organization

Reviews of proposed product changes for impact on regulatory status of the product

Monitor, schedule, manage, and document Phase Reviews ensuring appropriate use of CORE process and the development and commercialization of new products aligned with Division strategy including Director initiatives decisions and action items

Knowledge of manufacturing methods for medical implantable devices

Electro-Mechanical, Industrial Engineering, and engineering sciences plus 7-10 years of development and/or manufacturing process development; 21CFR, 820; ISO 14971 (Design Controls) FDA's Quality System Regulation and ISO 13485 regulations

Transfer of design specifications into manufacturing specifications (Design Transfer) including document preparation for Design History Files/Device Master Records/Risk Management

Engineering/Regulatory:

Knowledge of statistics, process control, and process capability

Formulate procedures, specifications, and process standards

Work with manufacturing, engineering, supplier quality, and other functional areas to assist and verify timely investigation and root cause analysis responses

Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements affecting the make versus buy decision

Establish process methods which meet performance and quality requirements

Identifying options and choosing the most appropriate processes methods

Reviews of proposed product changes for impact on regulatory status of the product

Development, execution, and reporting of CFR 820 compliant validations (SDLC)

Equipment Installation, Qualification, and calibration for medical device production

Operational & Production Qualification execution for medical devices

Prepare validation summary and technical reports for DOE results & findings (GDP)

Statistical Process Control skills; proficient in process development (Six Sigma)

Write and develop Engineering Specifications, and Process documentation procedures

Working knowledge of drafting standards, geometric dimensioning, and tolerances

Collect and analyze the performance of the new product development effort by collecting data for key metrics and reporting out the performance (GDP)

Manufacturing Processes Implementation with training and overall site rollout of new data gathering software systems and environmental monitoring (SPC)

Defining & Maintaining Quality Indicators and Process Performance Metrics

Expert knowledge of blueprint and schematic reading

Operations/Organization:

Author explanation reports and other documentation for internal & external customers

Committed to corporate goals of customer satisfaction and continuous improvement

Identification of key calibration requirements for equipment installation activities

Process expertise in operations/procedure development (Lean Sigma)

Provide training and/or guidance to new entry-level associates

Process expertise being responsible for incorporating, supporting, training, and improving CORE methodologies

Portfolio management by incorporating and supporting processes and tools used to identify, prioritize and select opportunities/projects for optimal portfolio value Work with Ops Managers for production opportunities and improvement activities, GIT

Lead selected core teams as directed by the business management

Devise and implement improvement strategies to processes, procedures and projects

Working within a team environment and building relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)

Supply Chain:

Ensures that suppliers have necessary information and facilities to deliver quality products

Investigates and analyzes supplier’s financial condition, technical competence, facilities and production techniques to ensure supplier capacity and capability

Vendor relationship management

Quality:

Devise, support, and implement corrective/preventative action plans (CAPA)

Responsible for assuring products conform to established requirements and standards

Support CAPA and Audit NC action tasks and manage the closure of internal/external audit actions and findings

Assist in product investigations as required (NCMR)

Leading Corrective and Preventative Action Teams through root cause analysis

Celestica, Inc.

925 First Ave. Chippewa Falls, WI

Operations Engineering Support/Lead Technician (9/2000 - 12/2003)

Perform and modify production test machines and modules with upgrades

Troubleshooting to the component level with failure analysis and trends

Coordinate Change Orders (ECOs and TCOs)

Focus on Critical Product for engineering, new product designs, test coverage, development, troubleshooting for product turn-around times, documentation, and a standards focus on record keeping and feedback

GMP, 5S, World Class, Lean, 6 Sigma, and Clean-room Manufacturing Training and Certification

Team building and empowerment

Dotronix, Inc.

3833 N. White Ave. Eau Claire, WI

Maintenance/Calibration/Production Technician (6/1990-9/2000)

Production Lead Technician: Selected as Production Floor Lead Technician: product support, troubleshooting and repair

Calibration Certification -Set up company-wide internal calibration

ISO 13485 Certification core team member

New Product Introduction(NPI) – Selected as lead NPI floor technician

Johnson Matthey, Inc.

620 Cashman Dr., Chippewa Falls, WI

Electro-Mechanical Maintenance Technician (8/1997-10/1997)

Production tool, fixture, machine support and improvement suggestions

Conceptualized and designed new product/production fixtures, tools, and constructed maintenance procedures and schedules

CERTIFICATIONS:

KNOWLEDGE:

Project Management Professional (PMI) – Boot camp (35 credit certification)

Process Validation Principles (two day course – 3 credits)

Metrology Fundamentals (one day course – 3 credits)

Vacuum Technologies, Freeze Drying, GE FANUC - Proficy (RTIP), Infor EAM, Windchill/QMX, Fabmaster, Windows O/S, MS Office, SolidWorks/Pro E (beginner), Unix, BT Basic, and MP2

STRENGTHS:

Leadership - Dominance, Influence, Steadiness (DISC)

Diagnosing, Adapting, Communication (Leadership Grid)

Personal - Communication, Execution, Achiever, Developer, Empathy, Equalization, Strategic/Scientific Thinking, Attention to Detail, Responsibility, Woo, Consistency, Teacher, Connector, Individualization, Input, Influencing

Interest – Scientific, Mechanical, Artistic, Outdoor (Birkman)

REFERENCES:

Available upon request.

Contact this candidate