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O firmie Allergan Aesthetics

W Allergan Aesthetics, firmie należącej do grupy AbbVie, opracowujemy, produkujemy i sprzedajemy portfolio najlepszych marek i produktów estetycznych. Nasze portfolio produktów estetycznych obejmuje preparaty do wstrzykiwań w obrębie twarzy, modelowania sylwetki, zabiegów chirurgii plastycznej, pielęgnacji skóry i wiele innych. Naszym celem jest konsekwentne dostarczanie naszym klientom innowacji, edukacji i wyjątkowej obsługi oraz dążenie do doskonałości — a wszystko to z akcentem osobistym. Aby uzyskać więcej informacji, odwiedź stronę www.AllerganAesthetics.com.

Sr. Validation Engineer

Primary Kalifornia Identyfikator oferty 2213806 Kategoria Engineering Dział Allergan Aesthetics

The Senior Validation Engineer will be responsible for planning, performing and documenting product validation and HFE (Human Factors Engineering) / UE (Usability Engineering) activities of a complex electro-mechanical systems with software.  It includes testing of User Needs and Design Inputs for electro-mechanical systems to ensure that the product works for the end user as intended. The engineer is experienced in all aspects of product development life cycle with strong understanding of medical devices design verification, design validation and Human Factors. This person will work with a multi-disciplinary engineering teams including software, electrical, and mechanical design engineers, and other product development function members to ensure validated product introductions for class II medical devices. 

Responsibilities:

  • Lead the validation and HFE / UE activities for complex electro-mechanical medical device products within the Product Development team
  • Responsible for planning, coordinating, performing and documenting Validation and HFE / UE activities ensuring related international standards are applied
  • Develop and maintain HFE / UE and design Validation plans, protocols and reports
  • Translate User Needs and Intended Use(s) into test Validation and HFE / UE protocols and validate that system works for the end user as expected and intended
  • Build Validation Lab and provide validation and HFE / UE direction and oversight of Validation Testing and HFE / UE in the Lab
  • Perform and document design Verification activities if required, depending on existing program needs
  • Support development of acoustic and thermal energy delivery devices using HFE / UE best practices and in accordance with current regulations and guidelines within the medical device industry
  • Contribute to risk analysis activities for the product development including providing inputs and reviewing hazards analysis, Design FMEA, and Use FMEA
  • Collaborate with internal and external partners and across functions with stakeholders, engineering, design, commercial, quality, and regulatory teams
  • Support project study design, methodology, data collection, root cause analysis to inform design and apply sound HFE / UE knowledge, experience and best practices to research, development, clinical studies, product verification and validation in support of regulatory submissions

 


Qualifications 

  • Master of Engineering or related technical field
  • A strong technical background in medical device verification, validation or similar
  • 10+ years of experience in regulated industry validating and performing HFE / UE activities for complex electromechanical systems
  • Strong understanding of Design Controls for medical device development including experience with medical device product life-cycle processes conforming to standards including ISO 13485, IEC 62366, IEC 62304, EU MDR, and ISO 14971
  • User center design / human center design experience
  • Proficient in using Requirement Management and Traceability tools
  • Technical leadership or program management experience with strong understanding of project / program management according to regulated product development process
  • Hands-on experience performing HFE / UE activities for high and low temperature, high acoustic, and high liquid pressure systems
  • Experience writing User Manuals and Work Instructions
  • An enthusiastic team builder and player
  • Strong communication, written and personal computer skills
  • Ability to earn trust, maintain positive and professional relationships, and strengthen our culture of inclusion

Desired Skills & Experience

  • 2+ years of experience performing design verification activities
  • Experience in medical device Software Verification or Validation
  • Experience performing Hardware and / or Software system verification testing

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

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