Product Development Engineering Manager

DuPont™ Spectrum™; Tucson (AZ); On-site; USD 130,000 - 180,000; Full time

Job summary

DuPont™ Spectrum™ is seeking a senior leader to guide the Product Development Engineering team through strategic initiatives and Stage Gate processes for new medical devices. You will drive cross-functional collaboration, set annual goals, and ensure timely, compliant releases.

You will oversee design controls, risk management, and continuous process improvements to meet regulatory standards and product requirements, while upholding safety and quality commitments across programs.

Qualifications

• Bachelor’s degree in engineering or equivalent experience.
• 10+ years industry experience in medical device design and development.
• 4+ years in leadership role (project management possible).
• Proficient in medical device design and development concepts and ISO 13485 requirements.
• Ability to lead cross-functional teams and manage complex programs.

Responsibilities

• Provides day-to-day guidance, direction, pace, and accountability for the Product Development team.
• Oversees New Product Development projects through Stage Gate process to commercialize new products.
• Defines and manages annual goals and objectives for team members.
• Drives project execution and design controls to final Commercial Release for ongoing production.
• Ensures regulatory and quality requirements are met and risk controls are effective.

Skills

Leadership

Project management

Communication

Problem solving

Attention to detail

Safety compliance

Education

Bachelor's degree in engineering or equivalent

Master's degree in Engineering (preferred)

Tools

Microsoft Project

Job description

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.

• 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

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.

• 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 valuesFollows all safety guidelines and adheres to safety absolutes

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

Qualifications

• Bachelor’s degree in engineering or equivalent experience in a related field.
• 10+ years industry experience
• 4+ years in leadership role (this could include project management)
• Proficient in commonly-used concepts, practices, and procedures within medical device design and development
• High degree of understanding of ISO 13485 requirements for Design Controls
• Experience as project manager on a project which involved all phases of product design and development, leading project team through the execution of project activities
• Demonstrates success developing full-scale project plans
• Effectively 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 their job function 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

Preferred

• Master’s Degree in Engineering discipline
• Proficiency in Microsoft Project
• Demonstrated ability to complete product design transfers
• Knowledge of applicable standards for EtO and Gamma sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)

Working Conditions

Works with minimal supervision from manager. Requires light physical activity performing non-strenuous daily activities