Product Development Engineering Manager

Spectrum Plastics Group•Tucson, AZ

5d•Onsite

About The Position

The Product Development Engineering Manager provides day-to-day guidance, direction, prioritization, pace, and accountability for the Product Development team, and sets and manages annual goals and objectives. The role develops and maintains a well-trained, motivated, cross-functional team and oversees New Product Development projects through the Stage Gate process to commercialize new products. The manager guides projects through the New Product Commercialization Framework (NPCF), maintains the Active Project List, and manages project activities for commercial release of product lines and associated manufacturing processes. The role is responsible for effective use of design controls, preparation and delivery of Stage Gate and Design Reviews, and ensuring that quality and regulatory requirements are met. It also applies risk management throughout development and improves product design and development processes, including design for manufacturability, scalability, testing, variability, and usability. The position ensures project deliverables satisfy Stage Gate requirements, including design freeze, a process suitable for validation, and successful validation outcomes leading to production launch. For medical devices for which DuPont Spectrum operates as legal manufacturer, the manager ensures the adequacy of design specifications, critical-to-quality (CTQ) requirements, risk management plans, and verification and validation plans, protocols, test methods, and reports. The role also supports requests for quotes involving complex devices that differ substantially from predicate devices, upholds DuPont's vision and core values, and follows safety guidelines and safety absolutes.

Requirements

Bachelor's degree in engineering or equivalent experience in a related field.
10 or more years of industry experience.
4 or more years in a leadership role; project management experience may count.
Proficiency in commonly used concepts, practices, and procedures for medical device design and development.
High degree of understanding of ISO 13485 Design Controls requirements.
Experience as a project manager on a project involving all phases of product design and development, leading a project team through execution of project activities.
Demonstrated success developing full-scale project plans.
Ability to communicate project expectations to team members and stakeholders in a timely and clear manner.
Experience managing financial responsibilities for major programs, such as budget accountability and revenue recognition.
Demonstrated problem-solving ability, including identifying errors and deficiencies and conducting research.
Ability to apply knowledge to job functions using pre-established guidelines and instructions.
Accuracy, attention to detail, and thoroughness.
Ability to comprehend and comply with company safety and quality standards.
Ability to provide oral and written instructions to others.
Responsible for understanding and complying with all SPG and DuPont safety policies and procedures.

Nice To Haves

Master's degree in an engineering discipline.
Proficiency in Microsoft Project.
Demonstrated ability to complete product design transfers.
Knowledge of applicable standards for EtO and Gamma sterilization, such as ANSI/AAMI/ISO 11135-1 and ANSI/AAMI/ISO 11135-2.

Responsibilities

Develop, set, and manage annual goals and objectives for team members.
Manage the performance and development of direct reports, fostering individual growth and development.
Guide day-to-day direction, pace, prioritization, and accountability for the Product Development Engineering team.
Ensure progress and successful execution of projects included in the New Product Commercialization Framework (NPCF), and maintain the accuracy and detail of the Active Project List.
Define and manage project activities for commercial release of product lines and related manufacturing processes, with sustainable, efficient, repeatable, and reproducible operations.
Drive project execution and effective use of design controls through the applicable Stage Gate process to final commercial release and ongoing production.
Prepare and deliver Stage Gate reviews and Design Reviews, ensuring quality and regulatory requirements are met.
Identify and implement improvements to the Product Development Process to meet regulatory requirements and ensure medical devices meet intended-use requirements.
Apply the Risk Management Policy to identify hazards, estimate and evaluate risks, control risks, and monitor the effectiveness of risk controls.
Identify and implement improvements to product design, including design for manufacturability, scalability, testing, variability, and usability.
Ensure project deliverables meet Stage Gate checklist requirements, including design freeze, establishment of a process that can be validated, and successful validation outcomes leading to production launch.
For applicable medical devices, ensure adequacy of design specifications, CTQs, risk management plans, and verification and validation plans, protocols, test methods, and reports.
Support requests for quotes, particularly for complex devices that vary substantially from predicate devices.
Uphold DuPont's vision and core values.
Follow safety guidelines and adhere to safety absolutes.