SUMMARY

• Effective Engineering Manager with a proven record in managing product ideation - design-development-launch and product life cycle support.
• Many years of progressive experience in medical devices, consumer products, machine tool, tooling design, automation and program management.
• Particularly effective during the evolution of technical projects from concept through implementation; translating customer needs into product specifications; converting concepts into tangible products and managing design releases to exceed customer expectations.

AREAS OF EXPERTISE

• Strong analytical background
• Diverse cultural team leadership and supervision
• Budget administration
• Training and development
• Strategic planning
• Team building
• MRP
• Strong computer and technology skills (hardware & software)
• Product management
• Product life cycle
• Reporting and documentation

PROFESSIONAL EXPERIENCE

Confidential, MI

Product Development Engineering Manager

Responsibilities:

• Generated and maintained the Design History File and CE - Technical File to ensure product development cycles of design planning, design input, design output, design review, design verification, design validation, design transfer, design change control and risk management processes conformed to FDA 21 CFR 820.30 regulations and European MD/PPE directives.
• Visited and technically spearheaded audits with external product certifying agencies such as BSI, TUV SUD- Germany and CFDA-China to ensure that products were compliant with regulatory requirements of the US, EU, China and other international markets.
• Using SolidWorks 3D-Simulation Pro. as the design platform, created multiple configurations of product designs, allowing rapid product portfolio expansion.
• Created business cases to analyze customer requirements and evaluated financial implications of Contribution Margin, ROI, IRR and NPV to justify new product introduction.
• Performed customer site visits to review system requirements, interacted with architects and structural engineers, generated system specifications, and ensured system installations performed to customer's satisfaction.
• Managed the capital equipment installer network via product installation training, contract management, purchase order issuance, and installation sign-off documentation control per ISO 13485 requirements of IQ/OQ/PQ.
• Built credibility and trust with existing customer base through resolution of after-sales and service issues.
• Winner of the " Top 5Innovative New Technology" award that addressed cardiology needs at the ACC2011 .

Confidential, MI

Manager, Engineering and Program Management

Responsibilities:

• Managed the design of cost effective and safe custom material handling solutions that served the aerospace, medical and automotive industries.
• Coordinated design checks on equipment releases for manufacturability and assembly using SolidWorks as an integral design tool.
• Provided support and guidance to machining and assembly shop floor teams .
• Reviewed project plans and interfaced with customers on product design features, performance, delivery commitments, field installation and equipment commissioning.
• Generated budget and labor requirements reports for the CEO, based on projects completion dates and sales forecasts.

Confidential

Product Manager

Responsibilities:

• Developed, executed on plans and provided management updates via Gate meetings on product manufacturing transitions across geographic facilities: achieving long-range organizational manufacturing footprint streamlining objectives.
• Reviewed, created and integrated product data codes in SAP for new product introduction and cross facility manufacturing transfer integration.
• Led the matrix cross-functional teams to achieve timely new product introductions following the Tech -21 New Product Introduction gating process.
• Generated consumer product line business growth by defining and developing product strategy for retail and professional channels, including optimizing the product line for profitability, SKU management, market analysis and demand forecasting.

Confidential, New Hudson, MI

Manager, Projects and Resource Pool

Responsibilities:

• Responsible for creating detailed quarterly and annual engineering budgets up to $5M to include project scope, schedule, and resource utilization.
• Supported implementation of Windchill's (PLM) system of product life cycle management.
• Co-ordinated third party FDA inspection and review of milk/juice filling machine designs and implemented suggested product design changes for 3-A standards compliance.

Confidential, Rochester Hills, MI

Product Engineering Supervisor

Responsibilities:

• Spearheaded product road mapping development and implementation across Business Units.
• Lead the strategic objective of building infrastructure through all stages of review, approval, and processing of engineering change notices.
• Developed costed BOM's, labor estimates, tooling, and capital requirements for product/program costing, NPV analysis and breakeven pricing.
• Consolidated and integrated engineering activities of two product acquisitions under different MRP structures.
• Created rule-based product configurators that assisted sales, customer service, and distribution in complex hierarchal product selection and BOM creation.
• Conducted Business Unit Finance projects such as equipment Lease v/s Buy pricing, Break-Even pricing analysis and Departmental Labor Utilization rate analysis.
• Ensured TSSA/PHSR design compliance for product sales to Canada .
• Designed, developed and introduced the adhesive dispensing industry's first high volume piston pump with a working pressure of 4500 psi.
• Created part-locating tooling for robot pick/place stations.
• Generated a planetary brush head module for nylon/wire brush part deburring.
• Designed load/unload stations for robotic buffing cells.

Confidential, East Pointe, MI

Mechanical Engineer

Responsibilities:

• Designed linear-wav slide conversion packages for machine retrofits.
• Conceptualized, designed, and implemented automatic part load/unload systems.
• Generated tooling designs and floor plan layouts for I.D./O.D. grinding machines.
• Generated PERT/CPM charts to improve the rebuild/retrofit procedure; evaluated labor requirement forecasts.
• Conducted shop floor machine tool run-offs and mechanical systems troubleshooting.
• Involved in Allen Bradley SLC and Dataliner display programming and debug.
• Led the customer shop-floor training on control systems for various CNC/PLC grinding machines.