Product Development Engineer III

4 days 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 making design changes or improvements to existing devices.

Key Responsibilities
  • Lead or participate in projects involving all phases of product design and development, guiding the Core Team through project activities.
  • Drive project execution through applicable project phases to Commercial Release for ongoing production.
  • Apply the Risk Management Policy to identify hazards, estimate and evaluate associated risks, control these risks, and monitor risk control effectiveness.
  • Optimize design and technology to drive innovation and significantly improve patient outcomes.
  • Ensure 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 creation of sub-assembly and final assembly drawings as design specifications for medical devices.
  • Develop verification and validation plans for protocols, test methods, and reports for design verification and validation testing.
  • Verify connection between product requirements, design inputs, design outputs, and verification/validation in traceability matrix.
  • Lead and ensure thoroughness of risk management activities as documented in Risk Management File, dFMEA, and pFMEA.
  • Evaluate and design products, parts, or processes for cost efficiency to minimize patient care costs.
  • Coordinate project activities for Commercial Release of product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations.
  • Define project execution activities to meet Product Development Process requirements.
  • 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.
Requirements
  • 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 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 applicable project phases to Commercial Release for ongoing production.
  • Knowledge of commonly-used concepts, practices, and procedures within medical device design and development.
  • Ability to 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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