EXPERIENCE:

Confidential, Fenton, MI

Sr. Product Development Project Manager

Responsibilities:

• Responsible for development of new Medical Devices for Acute Care Consumable and Acute Care Durable portfolios.
• Process and create new product ideas from external and internal inventors. Leads a multi - functional project team through the new product development process.
• Team members include Marketing, Sales, Intellectual Property, Regulatory, Quality, Finance, Purchasing and Logistics.

Confidential, Fenton, MI

Product Engineering Manager

Responsibilities:

• Manage a team of 4-5 medical device engineers for contract manufactured components such as compression molding, carbon fiber, assembly and positioning aids.
• Team also develops medical devices per Confidential 21 CFR 820/ISO 13485 product development process.
• Project management, defining and documentation for product/project/process specifications, defining and documenting quality requirements for product verification, estimating, product design, mold design, risk management, documenting work instructions, launching new product, testing, verification, and validation.

Confidential, Fenton, MI

Senior Lead Engineer

Responsibilities:

• Responsibilities include cradle to grave management of product development, design using SolidWorks 2015, verification and validation, risk management, instructions for use, and packaging.
• Tables and Confidential t transfer products are radiolucent class 1 capital equipment projects.
• Post development activities include field evaluation, development of custom site specific accessories.

Confidential, Fenton, MI

Verification and validation engineer

Responsibilities:

• Responsibilities include, creation, implementation, and finalization of the design verification files for the products technical file.
• Requirements include portions of IEC 60601-1 rev 3, full compliance to ISO 14971, IEC 62336, and ES60601-1.

Confidential, Fenton, MI

Senior lead engineer and design engineer

Responsibilities:

• Replacement of 4 various cad software packages into SolidWorks
• Elimination of 70% redundant engineering drawings for the largest product family at Confidential .
• Responsible for implementation of the engineering portion of ISO 13485 d) Implement SolidWorks PDM document vault in domestic and international plants

Confidential, Fenton, MI

Research and Development Engineer

Responsibilities:

• Develop new process for compression molding foam.
• Create specifications for the new compression forming process using a 300 Ton custom hydraulic press and a 30 ton custom electric press.
• Presses equipped with heated and cooling platens.
• Cradle to grave implementation of system and first run production.

Confidential, Flint, MI

Adjunct Professor

Responsibilities:

• Responsible for Planning, Scheduling, Directing, and budgeting for all engineering activities.
• Primary customer contact/program manager for parts through launch.
• Facilitate process development and improvement efforts for new and existing parts, components, and assemblies.
• Responsible for tool follow-up and development for new parts (dies, brake tooling, fixtures, and check gages).
• Product made using CNC laser, CNC press brake, Robotic, Mig, Spot, Welding, Stamping, e-coating & various plating processes
• Responsible for staffing and human resource needs as related to the engineering department.
• Part of the team responsible for PPAP, gauge R&R, and error proofing tooling and manufacturing processes.

Confidential, Auburn Hills, MI

Project Manager

Responsibilities:

• Cradle to grave management of several simultaneous projects.
• Main customer contact for project.
• Financial management of projects.
• Project change management.
• Time management using APQP project schedule milestones.
• Facilitator cross-functional project teams from inception to installation and warranty.
• ISO 9001, QS 9000, trained internal auditor
• Projects include power train machine load/unload (engine blocks), stamping tandem press-to-press transfer (body panels, bumpers), power train buffer for palletizing engine blocks, stamping, end of line auto-racking, and intelligent assist device for assisting ergonomic assembly of instrument panels.

Confidential, Fenton, MI

Die Change Engineering Manager

Responsibilities:

• Project Manager over major GM accounts of over $15 million at any one time. Stamping plants include Oshawa, Pontiac, Grand Rapids, and Mansfield.
• Product Manager over company largest profit center product line.
• Functional manager over the die-change-engineering group (10 employees) including hire/promotions/employee evaluations.
• Reduce time to market for a complete die change system by 25% by standardization of components and sub-assemblies.
• Act as a communication hub for proposals, new leads, and standardization.
• Research and Development of a new ASRS system for die storage and retrieval. This includes design, build, test, and initiate design and process improvements.
• Research and Development ancillary components for product line.
• Hydraulic drives, occasional use of variable frequency and vector drive systems.
• Site evaluations and plant layout specifications including coordination with Civil Engineering firms to ensure equipment is installed to specification.