Timothy Wade

** ******* *****, ****, **, *****

Home: 302-***-****

Cell: 302-***-****

Email: acqmpu@r.postjobfree.com

OBJECTIVE:

An Operations/Quality position utilizing proven leadership and problem solving skills to contribute to the efficiency and profitability of a fast paced progressive organization.

BACKGROUND SUMMARY:

Hands on engineer/manager with over 20 years experience in ISO 9000:2000, ISO 13485 certified and FDA regulated manufacturing for class I and class II medical devices. Experienced in all stages of manufacturing engineering support from R&D through to end of product life with expertise in:

Managing and supervising engineers and technicians

Process development, implementation and improvement using lean tools such as value stream mapping and standardized work for both production and administrative areas.

Interfacing with suppliers and OEM customers

Project management and leadership

Hands on training and support of engineering, quality and manufacturing operations

Selection, Implementation and Deployment of electronic systems such as Enterprise Resource Planning (ERP), Product Data Management (PDM) and other database system.

Management of department financials including payroll, project specific financials, and overall product gross and variable margins.

EXPERIENCE:

Qfix/Anholt Technologies, Avondale PA 2004-5/2015

Engineering Manager 10/2013-5/2015

Manage and supervise engineering, service and IT departments, including engineers, industrial designers and technicians.

Responsible for all aspects of design engineering process from concept through market release.

Work closely with Sales and Marketing to improve process for acquiring customer requirements to improve design outputs.

Implement aspects of lean product development including visual status boards, standard work for engineering, and value stream maps for product design cycle.

Implemented process for monthly management reviews of all open projects, including financials and post market feedback.

Manage design priorities based upon customer feedback, emerging technologies in the market place and product specific and overall company margin goals.

Manage intellectual property for the engineering group.

Quality Systems and Regulatory Affairs Manager 2004-10/2013

Managed and Supervised the Quality and IT departments, including engineers and technicians.

Responsible for all aspects of product quality, including vendor quality, process validation and verification.

Led successful implementation of ISO 13485 and ISO 9001 Certification and maintained subsequent re-certifications, with zero findings on the last two re-certifications.

Primary Quality interface for suppliers.

Led and managed implementation of ERP system.

Responsible for managing Regulatory Requirements for over 50 countries worldwide.

Implemented new Risk Management Process in compliance with ISO14971

Implemented Lean Manufacturing practices including Planned/Actual pull systems for inspection, 5S and Value Stream Accounting.

Managed quality aspect of supplier relationships with OEM customers, such as Philips, GE, Siemens and Varian to become certified suppliers, allowing over $4 million dollars in additional sales by becoming primary supplier for couch tops on specific OEM devices.

Successfully implemented a quality system with minimal staff by building quality into all operations throughout the company which led to a 40% reduction in scrap.

Implemented process for gathering and analyzing all customer feedback, including complaint data, and developing action plans for improvement leading to a 20% reductions in complaints per product shipped.

Responsible for creating and reviewing all regulatory submissions including CE Technical Files, 510K submissions.

Quality/Regulatory member of transition teams during the acquisition of various companies.

AGFA Corporation/Sterling Diagnostic Imaging, Inc., Newark DE 1997-2003

Technical Product Support Manager 2001-2003

Managed and supervised the Manufacturing Technical Group including engineers and technicians.

Project lead for the relocation of a $10 million repair operation to third party vendor.

Developed and implemented an equipment refurbishment process for returned equipment, which resulted in a $15K net profit per unit sold and additional film sales.

Performed root cause analysis on parts returned from the service organization.

Managed all Quality Control and Manufacturing Engineering functions while maintaining ISO9001-2000 compliance.

Lead technical interface with Global and NAFTA Marketing and Service organizations.

Developed and maintained Repair/Return Database for Glasgow, which allowed for a 300% reduction in labor hours and cycle time while significantly increasing the quality of the information retained.

Managed obsolescence issues for parts.

Developed and implement new repair/screening requests from service.

Lead technical interface with R&D activities.

Technical interface for suppliers.

Extensive SAP experience.

Senior Manufacturing System Engineer, 1997-2001

Product(s): Digital 200, Digital 400 Laser Medical Printers and accessories, Drystar Laser, Linx Printer Networks

The responsibilities and duties ranged from being an individual contributor to being a manager on projects, as well as for fellow engineers and technicians within the manufacturing department.

Writing and maintenance of assembly procedures.

Creation and maintenance of Bills of Materials.

Interfacing with design group during the introduction of new product implementation into the manufacturing process.

Manufacturing technical representative on the product team and software change control board.

Manufacturing representative with OEM customers such as Konica.

Key member of the transition team during the relocation of the product from Polaroid to Sterling.

Attained detailed knowledge of systems as a whole, including mechanical, electrical, optical and software components.

Technical support for printed circuit board testing both incoming and production floor rejects.

Supported Field Engineers with phone support and customer visits.

Direct supervisor for 3 electrical technicians

Polaroid Corporation, Newton, MA (Division Purchased by Sterling Diagnostic Imaging) 1992-1996

Manufacturing Engineer /Senior Manufacturing Engineer, Medical Imaging System Division

Product(s): Helios Laser Medical Printers

Worked in assembly area on following projects:

Interfaced with the design team and vendors to ensure that manufacturing needs are met.

Design and implementation of tests to verify system quality.

Attained detailed knowledge of systems as a whole including mechanical, electrical, and software components.

Train, lead and direct a team of technicians and operators.

Led 1996 Process Improvement Team, which led to a 15% reduction in product cycle time.

Symbol MSI, Inc., Bohemia NY 1989 - 1990

Manufacturing Engineering Aide, Co-op Position while attending Northeastern University

Product(s): Hand Held Laser Scanners

EDUCATION:

Northeastern University,

School of Engineering

Major: Electrical Engineering

TRAINING:

Romer CMM/Polyworks Training

Onsite lean training with DVIRC and Drew Locher

Lean Accounting Training (Maskell Associates)

Certified ISO 1348/ISO9000 Internal Auditor

FDA GMP, CMDR, CE, JPAL Regulatory Trainings

Design for Manufacturing Course

Statistical Engineering Training Program

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