Product Development Engineering Manager
About The Position
The Product Development Engineering Manager provides day-to-day guidance, direction, prioritization, and accountability for the Product Development team, and develops and maintains a well-trained, motivated, cross-functional team. The role sets annual goals and objectives, manages the performance and development of direct reports, 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 associated manufacturing processes, with an emphasis on sustainable, efficient, repeatable, and reproducible operations. The role drives project execution and use of design controls through the applicable Stage Gate, prepares and delivers Stage Gate and Design Reviews, and ensures quality and regulatory requirements are met. It also applies risk management throughout product development and identifies improvements to the product development process and product design. The position ensures project deliverables meet stage gate requirements, including design freeze, a process capable of validation, and successful validation outcomes that support production launch. For medical devices for which DuPont Spectrum operates as legal manufacturer, the role ensures the adequacy of design specifications, critical-to-quality requirements, risk management plans, and verification and validation plans, protocols, test methods, and reports. The position works with minimal supervision and involves light physical activity performing non-strenuous daily activities.
Requirements
- Bachelor's degree in engineering or equivalent experience in a related field.
- 10 or more years of industry experience.
- Four 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 execution.
- Demonstrated success developing full-scale project plans.
- Ability to communicate project expectations to team members and stakeholders in a timely and clear fashion.
- 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 understand and comply with company safety and quality standards.
- Ability to provide oral and written instructions to others.
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 the day-to-day direction, pace, prioritization, and accountability of 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 corresponding manufacturing processes, meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations.
- Drive project activities and effective use of design controls through the applicable Stage Gate to final commercial release for ongoing production.
- Prepare and deliver Stage Gate reviews to advance projects and Design Reviews to ensure 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 the 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 greatly from predicates.
- Uphold DuPont's vision and core values.
- Follow safety guidelines and adhere to safety absolutes.
- Understand and comply with SPG and DuPont safety policies and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
