Mark Albrecht

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

Stow, Ohio **224

Phone: 330-***-****

Email Address: adzfu3@r.postjobfree.com

Employment History

Zimmer Biomet Design Engineer (Contract)

****-**** ***********ities:

Design, Application and Process Failure Modes and Effects Analysis for Spinal Fixation and Fusion Devices (Legacy Products)

Product characterization for Occipital-Cervical-Thoracic Fixation System Cross Connector

Shipping Adoption Rationale for Legacy Products

Secondary Supplier Procurement for OmniSuite Cable Components

Feature Criticality Assessments for OmniSuite Components Coltene Whaledent, Inc. Senior Product Engineer

2009-2021 Responsibilities:

Project management

Risk management

Project engineer on cross functional project teams

Product design and improvement, Material selection, Bills of Material (SAP)

Intellectual property research

Private label and product in-sourcing

Legacy product support

Mechanical testing(three point bending/flexural property testing, tensile testing of elastic materials, product performance testing)

Finite element analysis-linear and non-linear(Contact) (SolidWorks) Accomplishments:

Helped launch endodontic rotary files used in root canal therapy

Assisted launching endodontic irrigation rinsing solutions and accessories used in root canal procedures

Released latex dental dam product characterized with having high elastic properties

Brought fiber post production in-house to increase profit margin (estimated cost savings greater than $500,000)

Assisted in acquiring FDA 510(k) for piezoelectric scaler used in endodontic root canal procedures

Launched pre-sterilized drills and posts

Worked within European Medical Device Regulation (MDR) for product labeling, design control process to ISO 13485 and risk analysis in accordance with ISO 14971 standard Experience with Design Control:

Documented user requirements, design requirements, functional specifications (design inputs), design outputs, verification and validation

Reviewed existing DHF and Technical Files coordinating with Regulatory Affairs personnel for dental pins, dental posts and dental drills to perform gap analysis for all relevant documentation as necessary

Conducted internal product performance testing, including writing test protocols and final test reports for verification and validation and oversaw outside testing as needed

Wrote Hazard Analysis, Risk Analysis and Usability documentation and collaborated with cross-functional teams for final approvals

Contributed to product labeling by initiating label approvals including primary and secondary product labeling and instructions for use

Responsible for product and labeling drawings, development of product and material specifications

Held product design and labeling reviews as necessary

Collaborated with Manufacturing Engineering to establish Manufacturing Work Instructions and Inspection Work Instructions to document procedures to build, label and test the product correctly

Determined critical dimensions and assigned them on component drawings which were used to confirm product met specifications by requiring measurements be taken at regular frequencies when work orders were issued in addition to first article inspections

Helped document Technical Files, Design History Files and Device Master Records for dental pins, dental posts and dental drills (all Class II devices)

Responsible for completion of Engineering Changes (ECRs) applicable to pins, posts and drill product lines

Worked with Notified Body to resolve questions pertaining to relevant notice of change requests submitted for approval

Collaborated with Regulatory Affairs personnel as needed to address questions or information requested from client countries pertaining to product(s) sold there for acceptance

Collaborated with Regulatory Affairs to maintain adherence to changing standards

Maintained bills of material for all pins, posts and drill product lines Delta Systems, Inc. Product Development Engineer

1997-2009 Responsibilities:

Solid modeling for conceptual and final product designs (SDRC I-DEAS, AutoCad)

Linear static finite element analysis (SDRC I-DEAS)

Project management

Plastic injection molded materials selection and testing (glass-filled polypropylene, flame retardant polypropylene, ABS, acetal, ASA, nylon, thermoplastic elastomers)

Design validation testing

Design of experiments to optimize injection molded part quality Accomplishments:

Helped introduce a custom 10% glass reinforced polypropylene combining good tensile and impact properties

Designed shorting connector to be used with a double pole plunger switch used to detect operator presence for a lawn and garden tractor application

Conducted design of experiments to optimize molding an injection molded component having a large localized mass to minimize sink

Helped develop a control module for school bus application to ensure driver visibility of children crossing in front of the vehicle to replace its predecessor which was susceptible to freezing in cold climates making it inoperable

Initiated use of regrind in plastics injection molding process which resulted in an estimated savings of 20% materials costs

Performed as an ISO 9001 internal auditor

Wheeler Boyce Company Design Engineer

1994-1997 Responsibilities:

Provided 2D design support (detail/assembly drawings) for rotational molds

Worked with production (pattern shop, foundry, bench and sandblasting departments, machine shop and final assembly) to ensure sound designs of molds and spider(multiple cavity mold assemblies)

Bill of material generation

Helped troubleshoot/resolve manufacturing problems Education University of Akron

Master of Science in Mechanical Engineering, 2002

Pennsylvania State University

Bachelor of Science in Mechanical Engineering, 1986 Erie County Vocational Technical School

Mechanical Drafting, 1980

Software Familiarity SolidWorks (solid modeling/simulation), SDRC I-DEAS(solid modeling/finite element analysis), 2D AutoCad/AutoCad LT, Microsoft Word, Microsoft Excel, Microsoft Project, Microsoft PowerPoint, SAP product data management, SAP (bills of material) Professional Organization Affiliations

The American Society of Mechanical Engineers American Society for Metals Society of Plastics Engineers American Society for Testing and Materials Project Management Institute

Certifications Passed Fundamentals of Engineering Exam (FE) Patents US D558, 155 S Switch

Plunger switch designed to fit a specific footprint US D597, 962 S Connector Housing

Housing designed to mate with power-take-off switch

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