Project Engineer / Mechanical Engineer

CLIFFORD R. DAHL

**** ******* ****, ******, **, *4724

Home: 716-***-**** Cell: 716-***-****

Email: **********@*****.***

PERSONAL PROFILE

*-*/* ***** ** experience in an ISO13485 quality and design control environment and 21 CFR 820 FDA environment with risk analysis experience using ISO 14971 standard and with significant experience in high power ultrasonic therapeutic medical devices. 3-1/2 years of previous experience designing Ultrasonic Cleaning Systems and using sheet metal. 14-1/2 years designing 6” and 8” wafer-size wet-etch and wet-clean automated and semi-automated semiconductor equipment. Performed and contributed as Project Leader, Team Leader, or Team Player in various projects. Have experience in SolidWorks 3-D modeling since 2001, Piezo-Tran acoustic transducer modeling, AutoCAD since 1990, Microsoft Office, Adobe Acrobat and Illustrator, and other Software. Have written and performed test protocols. United States Citizen.

EMPLOYMENT HISTORY

Sr. Mechanical Engineer, Cybersonics Inc., Erie, PA, November 2009 – May 2011

* Successfully designed and launched a new product, the Cybersonics Hollow Semi-Flexible Ureteral Probe for Ultrasonic Lithotripters, through the Special 510(k) FDA approval process, and provided the product to a customer for evaluation and validation.

* As team leader, successfully guided the initial use of the IEC 62366 Medical Usability Standard through the latest TUV audit and re-certification.

* Designed different versions of transducers for R&D and modeled existing transducers using Piezo-Tran.

Continually revised and changed labeling and existing Instructions-For-Use (IFU) manuals to ensure compliance to FDA standards and to clarify manuals and labels.

Using Design and Process Risk Analysis with Failure Mode Engineering Analysis (FMEA’s) and customer complaints, found areas of improvement and solutions in the manufacturing processes and product designs.

Lowered customer complaints, lowered manufacturing costs, and improved overall finished medical device products.

From CAPA reports (Corrective Action – Preventative Action), Document Change Requests (same as ECO’s, ECN’s and ECR’s) and manufacturing process faults, I improved designs and added necessary GD&T to drawings in order to lower manufacturing costs by lowering the number of re-worked or scrapped parts.

Analyzed and corrected work instructions for improved manufacturing processes and lower overall product costs.

Slashed R&D costs by using special software such as Piezo Tran in designing and modifying parts used in ultrasonic medical devices before sending drawings to outside vendors.

Wrote test protocols, performed tests, designed and used special test fixtures, and used special equipment such as laser vibrometers in gathering data used to verify and validate medical devices and to write test reports.

Saved all drawings and documents in a Product Data Management and/or Document Control vault program, such as PDMWorks and Synergy, as part of the Cybersonics quality document control procedure for each new or revised controlled document and drawing as part of the Quality System Record (QSR).

Reviewed and controlled overall project costs by creating and using BOM’s in MRP systems such as Exact Alliance and Exact Max.

Mechanical Engineer, Blackstone-Ney Ultrasonics (Cleaning Technology Group), Jamestown, NY, February 2006 – September 2009

* Designed, as project leader, the first automated all plastic non-ultrasonic cleaning system (over 1 Million Dollar Project) using corrosive chemicals in the cleaning/etching of inner light bulbs before bulbs go into flood light final assemblies.

- Trained technicians how to weld plastic sheets, fuse plastic pipe, connect plastic tubing, install and work with plastic parts, and modify plastic sheet.

* Slashed the price of the Grease Monkey Classic GMC-3523 Ultrasonic Cleaning System by 15% by simplifying the design of the tank and chassis and lowering the overall height of the chassis.

* Designed the first prototypes of the new MultiMeg System (generator chassis and megasonic plates) as a team member under the guidance of the Research and Development Department.

Designed and manufactured cost-effective and reliable stainless steel ultrasonic/megasonic cleaning equipment such as immersible ultrasonic transducers, tanks, manual systems and automated systems.

- Designed and managed installation of stainless steel plumbing that used off-the-shelf components such as pumps, valves, tubing, piping, fittings, etc.

- Wrote operation manuals, setup manuals, routers, and created BOM.s.

- Calculated exhaust, heating, liquid flow and drain requirements.

- Created plumbing and pneumatic schematics.

Under the direction of a project team leader worked on larger projects by helping in the design of equipment and making technical drawings.

Reviewed and controlled overall project costs by creating and using BOM’s and routers in a MRP system called Ultris.

Positions Held at SES America – Sankyo Engineering of America (same company: June 1991 through July 2005)

Technical Support and Service, SES America (formerly SES International), Phoenix, AZ 2002 – July 2005

Supported part sales by ensuring correct parts were shipped to customers and finding or designing replacement parts for obsolete parts.

Senior Mechanical Engineer, SES International (formerly Sankyo Engineering of America), Phoenix AZ 1999-2002, and Sankyo Engineering of America, Tempe AZ 1997 – 1999

Responsibility added of servicing equipment while also managing engineers in charge of different projects.

- Learned to draw, understand and use equipment electrical schematics in the upgrading and problem solving of equipment.

- Learned to write, modify, and use PLC and HMI programming in the operation and problem solving of equipment.

- Used diagnostic equipment in finding difficult problems and finding solutions.

Saved and managed all revisions of drawings, documents, and software in a safe location.

Lead Mechanical Engineer, Sankyo Engineering of America, Tempe AZ 1994 – 1997

Responsibility added of being project leader of installing equipment.

Responsibility added of leading, training and working with new engineers while working on the same projects.

Traveled with the Engineering Manager and Sales Staff and interacted with potential customers about tool requirements and supported sales by writing equipment specifications and preparing projected material costs.

Traveled to customer sites and provided technical help on processes and trained customer engineers and technicians on the new equipment operations.

- Performed risk assessments or FMEA’s with the customer as required by customer as part of the problem solving requirements.

Increased equipment reliability and uptime and improved serviceability by finding and using newer technologies and redesigning existing designs and parts.

- Implemented the use of ECO’s and ECN’s to keep track of revisions and changes.

Mechanical Engineer, Sankyo Engineering of America, Tempe AZ June 1991 – 1994

Helped in the installation of equipment in cleanrooms under the direction of the Engineering Manager

Designed, modified, and documented semiconductor automated wet-etch and wet-cleaning equipment.

- Created plumbing and pneumatic schematics.

- Designed tanks, process flow, automation fixtures, plumbing and plumbing components, pneumatics, enclosures, automation, chemical delivery systems and exhausts around material compatibility to chemicals and solvents and around purity requirements.

- Used the material choices of plastics, quartz and stainless steel in the design of the equipment according to material compatibility to hazardous chemicals, liquids and solvents and according to purity requirements.

- Calculated exhaust, heating, chemical flow and drain requirements.

Other Employment History

Mobile Home Setup, 1990 – 1991

CAD Conversion Operator, 1989

Robotics Operator, 1988 – 1989

Injection Molding Setup, 1987 – 1988; 1980 – 1982

EDUCATION

Bachelors of Science, Mechanical Engineering, University of Calgary, Calgary, Alberta, Canada, 1982 -1987

Continuing Education Courses: Electro-Mechanical Drafting, Mesa Community College, Mesa, Arizona, 1988 – 1990

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