Product Development Engineer III

3 days ago

Le Pontet, Provence-Alpes-Côte d'Azur, United States Spectrum Plastics Group, A DuPont Business Full time
Job Title: Product Development Engineer III

Spectrum Plastics Group, A DuPont Business, is seeking a highly skilled Product Development Engineer III to join our team. As a key member of our product development team, you will be responsible for designing new devices and components, as well as making design changes or improvements to existing devices and components.

Key Responsibilities:
  • Lead or be a team member on projects to bring new designs or design changes through the applicable phases of the Product Development Process.
  • Apply the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks, and monitoring the effectiveness of risk controls.
  • Optimize design and technology to drive innovation and significantly improve patient outcomes.
  • Ensure all applicable aspects of product design, including design for manufacturability, scalability, testing, variability, and usability.
  • Develop product requirements and design inputs based on applicable standards and other relevant sources.
  • Oversee and participate in the creation of sub-assembly and final assembly drawings to serve as design specifications for a medical device.
  • Develop verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testing.
  • Verify the connection between product requirements, design inputs, design outputs, and verification/validation in the traceability matrix.
  • Lead and ensure thoroughness of risk management activities as documented in the Risk Management File, dFMEA, and pFMEA.
  • Evaluate and design products, parts, or processes for cost efficiency to minimize the cost for patient care.
  • Coordinate project activities for Commercial Release of product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations.
  • Define activities for project execution to meet the requirements of the Product Development Process.
  • Support requests for quotes by outlining necessary project activities and timing for new product introduction.
  • Uphold Spectrum Plastics Group vision and core values.
  • Follow all safety guidelines and adhere to safety absolutes.
Qualifications:
  • Bachelor's degree in engineering or equivalent experience in a related field.
  • 3-7 years industry experience.
  • Demonstrated history of problem-solving, identifying errors and deficiencies, and performing research.
  • High degree of understanding of ISO 13485 requirements for Design Controls.
  • Ability to provide guidelines and instructions applicable to the job function.
  • Accuracy, attention to detail, and thoroughness.
  • Proficient computer skills.
  • Proficient communications skills.
  • Ability to comprehend and comply with company safety and quality standards.
  • Ability to provide oral and written instructions to others.
Preferred Qualifications:
  • Master's Degree in Engineering discipline.
  • Experience as project manager on a project involving all phases of product design and development, leading Core Team through the execution of project activities.
  • Knowledge on developing full-scale project plans.
  • Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion.
  • Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production.
  • Has knowledge of commonly-used concepts, practices, and procedures within medical device design and development.
  • Can handle financial responsibilities for projects such as budget accountability and revenue recognition.
  • Experience developing Gantt Charts in Microsoft Project.
  • Demonstrated ability to complete product design transfers.
Working Conditions:

Works with supervision from manager as necessary. Requires light physical activity performing non-strenuous daily activities.

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