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Sr. Engineer, Product Development (Cardia Surgery)

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Date: Nov 23, 2021

Location: Wayne, NJ, US

Company: Getinge

Job Purpose

Effectively develop and execute:

  • Support the Design and Development of New Product Concepts
  • Lead Product Design for Manufacturability
  • Lead Assembly Process and Equipment Development
  • Lead Device Qualification and Transfer to Manufacturing.
  • Support the various phase/steps of the Product Development Process.

Job Functions:

  • Provide input into project plan(s) which includes timing of tasks, resource planning, budgeting, and product cost.
  • Leads technical assessments relating to conceiving, designing, prototyping, and evaluating new product concepts.
  • Supports the definition and development of product requirements, specifications and working parameters using current engineering methods and technologies.
  • Leads development and execution of prototype builds and evaluations.
  • Leads product manufacturability assessments, and provide solutions to manufacturing challenges while maintaining product integrity.
  • Conduct design of experiments, gather results, analyze, draw conclusions, and make recommendations on product design elements.
  • Develop assembly methods to build prototype and production assemblies.
  • Develop test methods and test equipment for product evaluation testing.
  • Leads the development and execution of design verification and validation testing.
  • Supports the transfer of design from R&D to manufacturing.
  • As applicable, guide associate engineers and technician staff.
  • As applicable, interface with Physicians to build relationships and obtain product design feedback.
  • Applies expertise as an emerging authority in own engineering discipline or specialty areas.  Maintains good understanding of other engineering areas.
  • Interacts with engineers and managers, both inside and outside of Getinge on technical matters.  May provide training, technical advice and guidance to technicians or operators.

Minimum Requirements: 

  • Requires a BS or MS in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or equivalent, with at least 5 years related experience.
  • Must be able to analyze, assess and determine solutions to complex problems, be able to manage multiple tasks and effectively communicate technical issues both orally and in writing.
  • Must have a minimum of 3 years of applied experience in the use of Solidworks 2017 (or later) in the development of product assemblies, manufacturing fixtures, and equipment. Must be proficient enough to guide others through fixture development and product revision.
  • Must have knowledge of GMP, QSR, and good laboratory practices.  Previous experience with an ISO certified organization is highly desirable.
  • Experience in electrical design, schematics, with the ability to troubleshoot product electrical design issues highly desirable.
  • Experience in materials science and material selection for a desired function is highly desirable
  • Familiarity with statistical analysis and tools is highly desirable.
  • Prior experience in supporting multiple cross functional projects is highly desirable.
  • Prior exposure to clinical practices and products is preferred.
  • The ability to use Microsoft Office products such as Word and Excel or equivalent software applications is preferred.

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EEO Language for job advertisements:

 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.


Nearest Major Market: New Jersey