Product Development Engineering Manager

Spectrum Plastics Group•Tucson, AZ

About The Position

The Product Development Engineering Manager provides day-to-day guidance, direction, prioritization, pace, and accountability for the Product Development team, while establishing 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 defines and manages project activities for commercial release of product lines and related manufacturing processes, with a focus on sustainable, efficient, repeatable, and reproducible manufacturing operations. The role ensures that project deliverables meet Stage Gate requirements, design controls are applied, and projects progress through design freeze, process validation, and successful validation outcomes toward production launch. The position also helps ensure medical-device design and development activities meet applicable regulatory and quality requirements, including risk management, design specifications, critical-to-quality requirements, and verification and validation plans. The role works with minimal supervision and performs light physical activity during non-strenuous daily activities.

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 may count toward this experience.
Proficiency in commonly used concepts, practices, and procedures in medical-device design and development.
High degree of understanding of ISO 13485 Design Control requirements.
Experience as a project manager on a project involving all phases of product design and development, leading a project team through 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 ability to problem-solve, identify errors and deficiencies, and perform 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.
Ability to understand and comply 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 performance and development of direct reports, fostering individual growth and development.
Guide the day-to-day direction, pace, prioritization, and accountability of the Product Development Engineering team.
Ensure forward progress and successful execution of projects 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 corresponding manufacturing processes, supporting sustainable, efficient, repeatable, and reproducible operations.
Drive project activities 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 to advance projects and Design Reviews to verify that quality and regulatory requirements have been met.
Identify and implement improvements to the Product Development Process to meet regulatory requirements and intended-use requirements for medical devices.
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, a process suitable for validation, and successful validation outcomes leading to production launch.
For products where DuPont™ Spectrum™ operates as the legal manufacturer, 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 differ substantially from predicates.
Uphold DuPont™ vision and core values.
Follow safety guidelines and adhere to safety absolutes.