Senior Product Design Engineer

4 weeks ago

Irvine, United States altaviz, llc Full time

Senior Product Development Engineer


We are looking for someone who demonstrates:

  • Creative problem-solving expertise
  • Deep technical knowledge
  • Intense collaboration
  • Thoughtful, fast, disciplined execution
  • Tenacious commitment to excellence
  • Relentless drive to win


Here is a glimpse of what you’ll do:

  • Provide leadership to cross-functional product development teams during the pre-concept, development, design and documentation for new and improved disposable medical and surgical devices and instruments.
  • Support multiple project teams in developing and managing schedules and resources from concept through product launch. 
  • Execute projects with a sense of urgency and ability to break down barriers.
  • Identify and develop key external technologies.
  • Foster and maintain strong vendor relationships.
  • Manage communications and project activities with external customers, vendors, and strategic partners.
  • Perform project financial management including tracking and reporting.
  • Develop and oversee design history files within a project team structure. 
  • Write protocols/reports and independently analyze results of a moderate to high degree of technical complexity for review.
  • Provide technical support for regulatory submissions.
  • Perform special projects and other duties as assigned.


Here is some of what you’ll need:

  • Experience coordinating design controls including establishing functional and design requirements, generating risk analysis documentation, performing verification and validation activities and managing the design history file throughout the product development process. 
  • Complete knowledge of the product development process, engineering principles, concepts, and application from concept to commercialization.
  • Excellent analytical and problem-solving skills.
  • Practical experience with technical design, development, optimization, manufacturing ramp-up including test method validations, tolerance analysis, inspection methods and production processes.
  • Understanding of external standards, design controls, and quality controls.
  • Ability to prioritize and multitask. 
  • Good verbal and written communication with all levels of technical and operating management.


Here are a few of our preferred experiences:

  • BS or MS in Mechanical Engineering: B.S. Degree with a minimum of 7 years relevant experience or M.S. degree in of 5 years relevant experience.
  • Strong medical device development experience.
  • Knowledge of GMP’s, current FDA Medical Devices legislation and regulations.
  • Experience with designing plastic injection molded components for single- use medical devices.
  • Working level SolidWorks user.

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