Product Development Engineer III

5 hours ago

Le Pontet, Provence-Alpes-Côte d'Azur, United States Spectrum Plastics Group, A DuPont Business Full time
Job Summary

We are seeking a highly skilled Product Development Engineer III to join our team at Spectrum Plastics Group, A DuPont Business. 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 products.

Key Responsibilities
  • Lead or Participate in Project Teams: Function as a leader or team member on projects involving all phases of product design and development, leading Core Teams through the execution of project activities.
  • Drive Project Execution: Drive the execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production.
  • Risk Management: 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.
  • Design Optimization: Optimize design and technology to drive innovation and significantly improve patient outcomes.
  • Design for Manufacturability: Ensure all applicable aspects of product design, including design for manufacturability, scalability, testing, variability, and usability.
  • Product Requirements: Diligently develop product requirements and design inputs based on applicable standards and other relevant sources.
  • Design Specifications: Oversee and participate in the creation of sub-assembly and final assembly drawings to serve as design specifications for medical devices.
  • Verification and Validation: Develop verification and validation plans for protocols, test methods, and reports for execution of design verification and validation testing.
  • Traceability Matrix: Verify the connection between product requirements, design inputs, design outputs, and verification/validation in the traceability matrix.
  • Risk Management Activities: Lead and ensure thoroughness of risk management activities as documented in the Risk Management File, dFMEA, and pFMEA.
  • Cost Efficiency: Evaluate and design products, parts, or processes for cost efficiency to minimize the cost for patient care.
  • Commercial Release: Coordinate project activities for Commercial Release of products and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations.
  • Project Execution: Define activities for project execution to meet the requirements of the Product Development Process.
  • Requests for Quotes: Support requests for quotes by outlining necessary project activities and timing for new product introduction.
  • Company Vision and Values: Uphold Spectrum Plastics Group's vision and core values.
  • Safety Guidelines: Follow all safety guidelines and adhere to safety absolutes.
Qualifications
  • Education: Bachelor's degree in engineering or equivalent experience in a related field.
  • Experience: 3-7 years industry experience.
  • Problem-Solving Skills: Demonstrated history of problem-solving, identifying errors and deficiencies, and performing research.
  • ISO 13485 Requirements: High degree of understanding of ISO 13485 requirements for Design Controls.
  • Leadership Skills: Ability to provide guidelines and instructions applicable to the job function.
  • Accuracy and Attention to Detail: Accuracy, attention to detail, and thoroughness.
  • Computer Skills: Proficient computer skills.
  • Communication Skills: Proficient communications skills.
  • Company Standards: Ability to comprehend and comply with company safety and quality standards.
  • Instructional Skills: Ability to provide oral and written instructions to others.
Preferred Qualifications
  • Master's Degree: Master's Degree in Engineering discipline.
  • Project Management Experience: Experience as project manager on a project involving all phases of product design and development, leading Core Teams through the execution of project activities.
  • Project Planning: Knowledge of developing full-scale project plans.
  • Communication Skills: Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion.
  • Financial Management: Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production, including budget accountability and revenue recognition.
  • Gantt Charts: Experience developing Gantt Charts in Microsoft Project.
  • Product Design Transfers: 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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