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Process Specialist

Dorado, PR
DESCRIPTION
  • Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
  • Prepares and presents technical data and recommendations at technical reviews.
  • Writes validation protocols and reports applicable to new processes.
  • Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
  • Oversees development builds associated with the project using special work requests.
  • Develops qualified production lines.
  • Provides Design for Manufacturability (DFM) input to the engineering print package.
  • Contributes ideas to or generates Intellectual Property submissions.
  • May serve as a core team lead or extended team member on new development projects.
  • Possibly supervise and/or mentor engineers with the team.

 
EDUCATION
Bachelor’s degree in Engineering or related field education with 3-5 years or more of experience in the Regulatory industry.
 
REQUIREMENTS & SKILLS 
  • Demonstrated use of  DFSS tools (DOE, problem solving)
  • Minimum of 5+ years of demonstrated process development / improvement activities.
  • Demonstrated field experience with Vision Systems.
  • Experience working with silicone and/or medical adhesives
  • Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
  • Demonstrated ability to develop and drive innovative solutions into processes and products.
  • Medical Device Design experience; new product development
  • Process Development; equipment validations and process characterization and validation experience
  • Demonstrated cross functional teamwork in technically demanding environment
  • Demonstrated ability to develop processes from concept to production
  • Open to occasional travel
  • GMP & ISO knowledge, understanding and experience
  • Proficient in MS Word, PowerPoint, Excel, and Project
  • Effective interactions in a team environment
  • Team player, self-starter, persistent, tactful, and persuasive
  • Good organizational skills, detail-oriented & accurate, analytical skills
  • Effective verbal and written communication skills (writing and presentations)
  • Fully Bilingual (English and Spanish)
  • Able to work with minimum or no supervision
 
 
Ultimate Solutions Corp is an equal opportunity employer.

 

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