Product Development Engineering Manager

JOB PURPOSE:

Provides day to day guidance, direction, pace and accountability for the Product Development team as well as yearly goals and objectives. Develops and maintains a well-trained, motivated, cross functional team. Oversees all New Product Development projects through Stage Gate process to commercialize new products.

ESSENTIAL DUTIES:

• Develop, set and manage annual goals and objectives for team members.
• Manage performance and development of direct reports, fostering individual growth and development.
• Guide day-to-day direction, pace, prioritization, and accountability for Product Development Engineering team.
• Ensure forward progress and successful execution of projects included in NPCF (New Product Commercialization Framework) and the accuracy and detail of the Active Project List.
• Defines and Manages project activities for Commercial Release of expansive product lines and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations
• Drives execution of project activities and effective use of design controls through the applicable Stage Gate to the final Commercial Release for ongoing production
• Prepare and deliver Stage Gate reviews to advance projects to the next stage as well as Design Reviews to ensure all quality and regulatory requirements have been met.
• Identifies and implements improvements to the Product Development Process to ensure regulatory requirements are met and that the medical device meets the requirements for its intended use
• Applies 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
• Identifies and implements improvement, when needed, to all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability
• Ensures project deliverables adequately meet the requirements of the stage gate checklist, including design freeze, establishing a process that can be validated, and successful validation outcomes to lead to production launch of new products.
• For products where DuPontTM SpectrumTM operates as legal manufacturer for a medical device, ensure adequacy of design specifications, CTQ’s, risk management plans, and verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testing
• Supports request for quotes, specifically complex devices that vary greatly from predicates
• Upholds DuPontTM vision and core values
• Follows all safety guidelines and adheres to safety absolutes