Dagan Frey Email & Phone Number

Temecula, Ca, Us

Palm Springs, California, United States

Carlsbad, California, United States

HRC (Hospital Respiratory Care)

Andover, Massachusetts, United States

MA&TC (Monitoring Analytics and Therapeutic Care)

Palm Springs, Ca

• Coordinated, mentored and managed the daily activities of up to 14 Engineers and Technicians within the Manufacturing Engineering and Test Engineering Departments o Oversaw efforts directed at improving yields/lowering manufacturing costs and addressing customer corrective actions o Established priorities and tracked progress to task completion o Coordinated with other departments to schedule work activities as needed o Resolve employee roadblocks o Guide employees through the implementation of change• Maintained department budget and tracked budget to spend in support of financial objectives• Operations representative for: o Design controls process deliverables such as approval of design development plans and phase review record approval o CAPA Excellence Team (CET) for review and approval of all Corrective Action and Preventative Action (CAPA) activities• Managed Preventative Maintenance program to ensure compliance to regulations• Successfully supported the Palm Springs site through multiple FDA Inspections and External/Internal audits with zero 483’s, no major non-conformances and/or high risk observations• Worked cross functionally with Sustaining/R&D Engineering in the development of multiple regulatory update design changes, obsolescence design changes and New Product Introduction development projects • Lead “make vs. buy” sourcing evaluations for multiple high level assemblies (HLAs) in support of corporate initiatives on capital equipment programs• Lead the efforts of a lean manufacturing “one piece flow” implementation on two capital equipment programs• Collaborated with resources at multiple site locations

Palm Springs, Ca

• Coordinates and supervises the daily activities of business support, technical or production staff in an assigned area• Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors• Has in­depth knowledge of work processes and tools within own area• Applies expertise to solve standard and non­standard problems within own area• Managed Preventative Maintenance program to ensure compliance to regulations• Maintained production line layouts in support of factory initiatives and new program/product development• Lead the implementation of semi-automated test fixtures as part of corporate initiatives to improve quality and process• Authored the “Production and Process Controls” section of the Quality Management System (QMS) to close what was an existing gap between R&D and Manufacturing transfers.• Collaborated with resources at multiple site locations • Lead quality management system (QMS) harmonization efforts between multiple sites

Plymouth, Mn

• Lead quality management system (QMS) harmonization efforts between multiple sites• Collaborated with resources at multiple site locations• Use manufacturing engineering knowledge to design and develop innovative Type II medical devices or components/subsystems in support of company's strategic plan. • Apply mechanical engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost. • Solve manufacturing engineering problems at the component through system level. • Conduct testing utilizing existing test protocols or develop new ones as needed. • Generate written reports. • Assign work to technicians and temporary workers as needed. • Complete projects (including product enhancements) in a manner consistent with corporate objectives. • Maintain accurate documentation of concepts, designs, drawings, and processes. • Provide manufacturing engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs. • Oversee outside vendors and consultants as required. • Maintain Quality System Records (QSR), including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. • Provide manufacturing engineering support in the resolution of product complaints and/or safety issues. • Work with other engineering, manufacturing, clinical affairs, sales and marketing, and quality assurance staff to coordinate pilot production of new products. • Support company goals and objectives, policies and procedures, QSR, and FDA regulations.

Minneapolis, Mn

- Define and document manufacturing processes and procedures for: o Filling and sealing of a container containing hazardous materials o Ultrasonic welding o Electromechanical device assembly meeting IPC 610 & 620 requirements- Execution and continued development of manufacturing processes- Identification and corrective action support of manufacturing issues associated with product(s)- Define manufacturing layout/floor plan- Establish and maintain Electro Static Discharge (ESD) program- Identification and procurement of tooling and fixturing needed to support manufacturing process- Qualification of manufacturing equipment and processes (IQ/OQ/PQ)

Hutchinson, Mn

-Lead assigned and identified projects directed at improving yields/lowering manufacturing costs and addressing customer corrective actions-Co-coached/co-mentored 3 engineers and 3 technicians to guide product/process improvement efforts to meet project goals -Added responsibilities described under Process Engineer / Manufacturing Engineer role below

-Worked directly with the Strategic Business Unit (SBU) to execute plans to achieve profitability, quality, and customer demand goals-Identify & report on product yield gaps to establish what projects and resources are needed to close the issues. -Oversee & report on product improvement activities and how they track to program development milestones. -Identify priorities & resource alignment to complete projects as needed.-Lead process and product transfers to high volume manufacturing-In-directly managed 3 engineers and 2 technicians on: oProduct and process improvement efforts to meet program goals oAnnual performance reviews oPerformance improvement plans oResponsibilities as described under Process Engineer/Manufacturing Engineer

-Assess process capabilities (CPK & PPK) and control by use of statistical process controls (SPC) analysis-Apply Six Sigma techniques:o5 why’s ; Analysis of variance; Control Chart; Design of Experiments (DOE), DMAIC, FMEA-Apply lean manufacturing techniques:oValue Stream Mapping; 5-S, Kanban; Poka-Yoke-Prioritizes and implement process improvement opportunities -Apply technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation. -Conducts technical reviews of product performance -Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOMs, Routings, FMEAs, etc.) -Aide in the development of qualified production processes to turn over to volume manufacturing. -Provide Design for Manufacturability (DFM) input to the engineering print package. -Provide work direction to technicians and manufacturing personal.-Solve manufacturing issues that arise during product builds-Perform testing to validate and prove manufacturing readiness-Create/maintain/optimize product part files, to turn over to volume manufacturing-Define and implement efforts to cut production lead time-Optimize product layouts and processes to reduce manufacturing costs and waste-Supported process and product transfers to high volume manufacturing

Bachelor Of Science - Bs, Manufacturing Engineering Technology

Associate Of Science - As, Pre-Engineering

High School Diploma, General Studies