Product Development Engineering Manager

Job Details: Job Location: Xeridiem - Tucson - Tucson, AZ, Position Type: Full Time, Salary Range: Undisclosed, 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

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