Validations/ Verifications Engineer

Karwell Technologies

  • Boston, MA
  • 30+ days ago

    Highlights

    People Management: ability to ensure small delays don't derail critical items and work with embedded team on site to ensure smooth implementation. Strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively through strong technical and/or project leadership experience.

    Numbers & Facts

    LocationBoston, MA

    Description

    Roles & Responsibilities:
    • Conducting Process Verifications / Validations.
    • Design and/or Process Failure Modes Effects and Analysis.
    • Blueprint reading/literacy/inspection methods & techniques including GD&T.
    • People Management: ability to ensure small delays don't derail critical items and work with embedded team on site to ensure smooth implementation.
    • Strategic Mindset: ability to think bigger picture and work with Senior leadership on long term strategy for area/site.
    • 3Performing risk management, execute product testing.
    • Work on Quality System, including, but not limited to corrective & preventive actions, nonconforming materials, risk management, and medical device regulations.
    Requirements:
    • A Bachelor's degree in Technical or Scientific discipline.
    • 5+ years of work experience in medical device industry.
    • Experience conducting Process Verifications / Validations.
    • Experience conducting Design and/or Process Failure Modes Effects and Analysis.
    • Excellent problem solving and decision-making skills.
    • Interpersonal skills that foster collaboration as they relate to technical situations.
    • Strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively through strong technical and/or project leadership experience.
    • Design Quality Engineering experience.
    • Design Control experience.
    Preferred:
    • An advanced degree.
    • A Bachelor's degree in Mechanical Engineering or Bioengineering.
    • New Product Development experience.
    • Experience with Blueprint reading/literacy/inspection methods & techniques including GD&T.
    • Strong experience with Design Excellence, Six Sigma, or Lean.
    • Spanish as a second language.
    Generic Managerial Skills, If any:
    • Required to have good communication skills both written & verbal and be computer literate (Word, Excel, outlook Email - a must).
    • Strong interpersonal, organizational, written and oral communication skills.
    • Dependable, somewhat assertive, reasonably organized, resourceful and communicative with an ability to adapt and learn quickly as well as follow verbal and written instruction, detail oriented.
    • Must Have Technical/Functional Skills.
    Desirable Skills:
    • EIS: Medical Device & Regulations ~EIS : New Product Development (NPD) Methodology and Management.
    • Experience Required: 4-6.
    • 5+ years of work experience in medical device industry

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