Product Development Engineering Manager

Xeridiem Medical Devices; Tucson (AZ); On-site; USD 120,000 - 180,000; Full time

Job summary

Xeridiem Medical Devices is seeking an experienced Product Development leader to guide a cross-functional team through the full spectrum of medical device development. You will set yearly goals, manage performance, and ensure timely Stage Gate progress toward commercial release while maintaining regulatory and quality standards.

Responsibilities include design reviews, risk management, manufacturability improvements, and collaboration with stakeholders to drive successful product

Qualifications

• Bachelor’s degree in engineering or related field.
• 10+ years industry experience in medical device development.
• 4+ years in leadership role.
• Strong knowledge of ISO 13485 Design Controls.
• Experience managing Stage Gate through product development.
• Proven ability to manage budgets and revenue recognition.
• Experience design transfer and scale-up for manufacturing.

Responsibilities

• Provide day-to-day guidance and direction for the Product Development team.
• Set annual goals and objectives and drive accountability.
• Oversee Stage Gate process for commercializing new products.
• Lead design reviews ensuring regulatory and quality requirements are met.
• Ensure design for manufacturability and scalability across production.
• Drive risk management and verification/validation activities.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory understanding

Risk management

Design controls

Communication

Problem solving

Quality assurance

Education

Bachelor’s degree in engineering

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.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 operationsDrives execution of project activities and effective use of design controls through the applicable Stage Gate to the final Commercial Release for ongoing productionPrepare 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 useApplies 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 controlsIdentifies and implements improvement, when needed, to all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usabilityEnsures 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 testingSupports request for quotes, specifically complex devices that vary greatly from predicatesUpholds DuPontTM vision and core valuesFollows all safety guidelines and adheres to safety absolutesBachelor’s degree in engineering or equivalent experience in a related field.10+ years industry experience4+ years in leadership role (this could include project management)Proficient in commonly-used concepts, practices, and procedures within medical device design and developmentHigh degree of understanding of ISO 13485 requirements for Design ControlsExperience as project manager on a project which involved all phases of product design and development, leading project team through the execution of project activitiesDemonstrates success developing full-scale project plansEffectively communicate project expectations to team members and stakeholders in a timely and clear fashionExperience managing financial responsibilities for major programs, such as budget accountability and revenue recognitionDemonstrated ability to problem solve, identify errors and deficiencies and perform researchAbility to apply knowledge to their job function using pre-established guidelines and instructionsAccuracy, attention to detail, and thoroughnessAbility to comprehend and comply with company safety and quality standardsAbility to provide oral and written instructions to othersResponsible for understanding and complying with all SPG and Dupont safety policies and proceduresPreferred:Master’s Degree in Engineering disciplineProficiency in Microsoft ProjectDemonstrated ability to complete product design transfersKnowledge 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