IMELDA SAGER

CONTACT PROFILE
Team leader with 30+ years in the medical device field within Manufacturing,
(408)204-9010 Research & Development and Quality Assurance Departments. A hard-working
professional, who demonstrates initiative by improving product processes,
idsager18@gmail.com accomplishing assigned tasks and meeting critical deadlines. My goal is to obtain a
challenging position in the medical device industry.

 MICROSOFT EXCEL
EXPERIENCE
 WORD Production Supervisor / R&D Technician
2017 – Present | Tusker / Smith+Nephew
 POWERPOINT
o Work with engineers and manufacturing engineers to resolve issues and suggest
 AGILE PRODUCT improvements.
o Maintain work order records utilizing the QAD MRP System.
LIFECYCLE o Maintain clean room integrity by using proper attire and adherence to clean room
environment practices and procedures.
MANAGEMENT
o Support other departments as assigned.
SOLUTION o Assist with laboratory testing protocols and document results.
o Train new hire and other team members with new process.
 QAD MFGPRO o Work with engineer with design and development, building prototype
o Perform design verification and validation.
SOFTWARE o Transfer documents to manufacturing, and review Manufacturing Process Instruction
o Familiar in issuing NCR
 MICROSOFT PUBLISHER o Highly familiar with all Tusker/ Smith-Nephew products and processes.

EDUCATION Sr. Manufacturing Technician/Production Supervisor

2010 – 2017 | Pivot Medical / Stryker
o Manage and reports daily production results, including material usage waste and
Bachelor of Science & downtime.
Commerce: Business o Cooperate with Quality Control in maintaining quality standards, complying with
appropriate corrective measures resolving deficiencies.
Management o Manage personnel issues, including vacation approval, time card approval, daily and
University of Cordilleras (Phillippines) weekly overtime.
o Assist with development and implementation of policies.
o Manage equipment and facility sanitation; initiates corrective action to resolve
deficiency.
o Maintains safety program and all required safety training for employees.
o Maintain work order records utilizing the QAD MRP System.
o Train new hire and other team members with new process.
o Perform design verification and validation.
o Transfer documents to manufacturing, and review Manufacturing Process Instruction
o Work with engineer with design and development, build prototypes.
o Assign daily work orders for Sub-assembly / Final Assembly and delegate to team
members.
Product Development / Sr. Operation Technician
2009 - 2010 | TDC Medical
o Prototype, product and process development: work with Engineers to develop quality
and functional prototypes, products, and processes that contribute to the company
objectives.
o Offer excellent assembly knowledge, which includes processes and documentation.
o Perform incoming inspection on receivable components (familiar with pin gage,
calipers, snap gage and Ram Optical Instruments).
o Familiar in creating document such MPI’s, LHR, BOM, DCO’s and Rework Instructions.
o Familiar with MFG Pro System.
o Perform shipping and receiving functions, manage inventory of all materials and
components. Kitting work orders.
o Perform design verification, PQ and OQ for product.
o Perform surface treatment on metal and plastic components (i.e. Grit Blasted Wet &
Dry, Sand Blasting).

R&D Engineering Support/Sr. Manufacturing

Engineering Technician
2007 - 2009 | Benvenue Medical
o Lead Design Verification, Design Validation and Clinical Trial Product Builds.
o Train new hires with processes and documents, Initiate documentation for Benvenue
product line (i.e. MPI, LHR, BOM), generate LHR format in MFGPro. Initiate and
review DCO’s, Rework Instructions & NCR’s.
o Manage engineering level documents and transfer/release to Document Control.
o Support incoming inspections (First Article Inspection, Receiving Parts). Perform
shipping and receiving functions. Manage inventory of all CER materials and
components.
o Offer excellent assembly knowledge, which includes processes and documentation.
o Familiar with Titanium, Stainless Steel, Nitinol Wire. Familiar with engineering plastics
such as Nylon, Peek, Polypropylene, Polycarbonate, ABS (Acrylonitrile Butadiene
Styrene).
o Familiar with engineering adhesives Cyanocrylae, Epoxy, and UV cure.
o Takes initiative in making suggestions for process improvements ad fixtures.
o Familiar with measuring instruments: Calipers, Snap gage, Micrometer, Ram Optical
Instruments and Optical Comparator.
o Basic machining skills (Drill press, Mill).

Process Engineering Technician IV / Product Transfer

Lead Technician – Costa Rica(Trainer)
1997 - 2007 | ArthroCare
o Prototype, product and process development: Work with Engineers to develop quality
and functional prototypes, products, and process that contribute to company
objectives.
o Product Testing: work with Engineering to perform testing and development test
methods and apparatus for evaluating the product quality and functionality.
o Closely work with engineers in developing and implementing new manufacturing
processes, create drawings, supporting validations and maintain laboratory notebook.
o Highly familiar with technical features of all product lines.
o Write MPI’s, test and validation protocols for products with minimal support from
engineers. Validate new test methods and apparatus to evaluate safety and reliability
of product.
o Manage product transfer documents between Sunnyvale and Costa Rica facilities.
o Train local and international assemblers on new product assembly and process
updates.
o Collaborate with engineers to design new fixtures, equipment and tooling.
o Create ECN, releasing tools, fixtures, components drawings and do first article.
o Familiar with engineering materials such as adhesives, heat shrink tubing and
polymers.