AbbVie

Director, Medical Device Engineering Validation & Testing

Employer
AbbVie
Location
Pleasanton, California
Posted
Jan 13, 2022
Ref
2122099
Required Education
Bachelors Degree
Position Type
Consultant
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

A proven and experienced engineering leader, this individual is responsible for planning, conducting and directing the systems level testing activities within the body contouring R&D team. The person shall be experienced in all aspects of product development with emphasis on systems integration with a strong understanding of complex electro-mechanical systems with software. The person will provide input into User Needs definitions, system requirements, risk assessment, usability engineering, and systems integration to ensure robust testable specifications are developed. The individual is a champion of cross functional collaboration, both within R&D and across the broader development team.  

Responsibilities include: 

  • Within the Product Development team lead the planning and directing of system integration level testing activities for complex electro-mechanical medical devices.
  • Acts as a consultant with the engineering team to translate customer needs, research findings and business requirements into testable product requirements and specifications.
  • Ensure system integration and appropriate supporting documentation meets all safety and regulatory compliance.
  • Expert knowledge of design control requirements for releasing equipment including situations where regression testing is sufficient and EMC/EMI certified body testing.
  • Develop strategies for Design Verification and Validation (working with commercial) across multiple device types.
  • Develops new or refined applications of engineering principles used in analysis and testing, such as validating novel testing tools or automated testing tools.
  • Develop and implement processes to support development activities from a system integration perspective, e.g. requirements management, software defect tracking.
  • Determines project needs and assigns personnel to ensure milestones are met.
  • Develop and implement robust software testing controls such as Software Change Control Board.
  • Maintain a controlled lab for all on markets products and products in development updated to the latest revisions of hardware/software.
  • Assures procurement of necessary equipment to complete project testing related activities, including equipment for clinical evaluation/ validation activities.
  • Communicate and collaborate with a wide range of project contributors and stakeholders spanning the organization, and external partners.
  • Collaborate with technical leaders for product design, development, integration, testing, and reliability improvements.
  • Support usability evaluation plans and conduct and coordinate usability testing activities as necessary with released equipment or equivalent work flow simulators.
  • Hires, trains, directs and develops a competent technical staff that can effectively carry out all required functions.
  • #LI-PD1


    Qualifications
    • Bachelor’s/Master’s Degree in Engineering with specialization in medical device development with 15 years of relevant work experience 

    Additional Requirements: 

  • Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
  • Requires at least 10 years of technical leadership or team management experience
  • Strong understanding of Design Controls for medical device development including software testing for medical device applications.
  • Strong understanding of project/program management is required with an understanding of the FDA product development process.  and understanding of PLM are a plus.

  • Significant Work Activities
    N/A
    Travel
    No
    Job Type
    Experienced
    Schedule
    Full-time
    Job Level Code
    D
    About AbbVie
    AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
    Equal Employment Opportunity
    At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.