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Sr. Product Development Engineer

Company: Envista Holdings
Location: Thousand Oaks
Posted on: January 10, 2022

Job Description:

Implant Direct is part of Envista's portfolio of dental product and service companies, including more than 30 trusted brands and over 125 years of dental excellence. With over 4.6 million implants placed worldwide, Implant Direct enables dentists to advance their patients' oral health with high-quality dental implant solutions. All implants are manufactured in the USA using only medical-grade titanium alloy, meeting the industry's highest performance and safety standards. We offer a unique portfolio of products and solutions that elevate the performance of your practice through predictable outcomes, greater patient satisfaction, and reduced total costs. We are committed to renewing confidence and changing lives through enhancing patient access. For more information about Implant Direct, visit www.Implantdirect.com

Job Description:Job Summary:The Sr. Product Development Engineer is engaged in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market. In this role, you will participate in Concept Development, Design & Development, Design Verification & Validation, and Design Transfer. You will serve as a core team member of the Design Engineering team working independently with minimal guidance, while partnering with cross-functional experts on projects. You will participate in the planning and execution of project team leader activities related to Design Verification & Validation activities including product & packaging performance evaluation, Biocompatibility assessment, Usability Studies and Sterilization Validation assessment.Essential Duties:

  • Perform project team leader activities to design and develop new technologies.
  • Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30.
  • Create various elements of the Design History File and Technical File, using Design Control.
  • Participate in the following Design Control activities: Design and Development Plan, Design Input, Design Output (e.g. engineering drawings, specifications, labels, packaging), Design Verification and Validation (e.g. write protocol, perform testing, write test report, write engineering rationale), and Design Transfer.
  • Conduct risk management activities and document results ensuring compliance with internal procedures and ISO-14971.
  • Conduct biocompatibility evaluations and generate documentation ensuring compliance with internal procedures and ISO 10993-1.
  • Perform Finite Element Analysis.
  • Perform statistical analysis for test results and sample size rationalization.
  • Partner with cross-functional Core Team Members to drive the project through completion; perform project management tasks
  • Generate documentation of Technical Files per CE Marking requirements.
  • Review dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines.
  • Review and approve drawings, applying knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5.
  • Acts a knowledgeable resource for colleagues and team members.Job Requirements:Education/Experience:
    • Bachelor's degree in Mechanical Engineering (preferred) or Biomedical Engineering with minimum 6 years' experience in product development activities of medical devices, or
    • Master's degree in Mechanical Engineering (preferred) or Biomedical Engineering and minimum 4 years' experience in product development activities of medical devices
    • Experience in new product development of medical devices.
    • Proficient in 3D CAD modeling and Engineering Drawings (SolidWorks)Preferred Skills:
      • Experienced with Design Control and Risk Management per 21 CFR Part 820, ISO 13485, ISO 14971
      • Knowledge of ISO 10993 for Biological Evaluation and ISO 11737 for Sterilization.
      • Knowledge of Usability Engineering per IEC 62366-1
      • Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.#LI-PB1IND123Operating Company:Implant DirectEnvista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Keywords: Envista Holdings, Thousand Oaks , Sr. Product Development Engineer, Engineering , Thousand Oaks, California

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