Associate Director, Plastics Product Developmentother related Employment listings - Irvine, CA at Geebo

Associate Director, Plastics Product Development

The Associate Director Plastics Product Development provides technical leadership contributing to the ideation, design and development of medical devices addressing unmet clinical needs. At a minimum, may lead a Product Development team and/or technical team in the design and development of new products without direct supervisory responsibilities. May also take on supervisory role (hiring, managing performance, etc.) of contractor or permanent Product Development engineers and/or technicians.
Responsibilities:
1 New Product Development:
Serves as Product Development Team Member for projects and may serve as Technical Lead for highly technical projects within the Growth Product Flow (GPF) stage gate process and / or Product Presentation & Device Strategy Team (PPDST) Co-Chair within the Asset Strategy Team (AST) Model; establishes and manages project level timelines, budgets and resource needs with project teams and leads the development and execution of technical strategies Partners closely with Marketing to establish user requirements and then translates them into clinically relevant technical requirements through research and customer interactions Develops and/or applies physical and mathematical models in support of product design; develops complex experimental designs and protocols to demonstrate product feasibility; analyzes and resolves complex design problems associated with product performance Designs products, including prototype development of devices, fabrication, verification testing and analysis; applies understanding of surgical procedures, products and trends in related therapeutic area to product design Develops technical specifications (design and test, and test method development) to meet product requirements; applies advanced engineering principles to the design, fabrication, testing and evaluation of products and when resolving technical challenges Prepares and delivers technical and business stage gate presentations to internal and external customers, including senior management Identifies outside vendors and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines Leads technical reviews; reviews and approves the work of more junior engineers, scientists and lab associates; coaches and mentors junior staff 2. Innovation:
Leads Plastics Pre-Concept Team in ideation and assessment of new product concepts aligned with franchise strategy. Innovates by identifying, investigating and evaluating existing technology; designs and implements new methodologies, materials, machines, processes or products. 3. Post-Transfer/Sustaining Engineering Support:
Serves as technical/design control expert to support Regulatory, Quality, Manufacturing, Marketing and Sales as needed Supports Change Control Assessments Bachelors Degree in engineering or related field with 10-12 years Product Development experience, or Masters degree with 6-8 years Product Development experience, or PhD with 5-7 years Product Development experience Medical device experience or experience in a regulated environment Experience developing products within a business stage gate process (preferred) Essential Skills, Experience, and Competencies Demonstrated critical thinking and problem solving skills Ability to exercise judgment both within defined procedures and policies, in the face of ambiguity and balanced across technical and business needs Makes timely, high-quality decision with less than perfect information, seeking out and considering diversity of input Ability to manage diverse, simultaneous projects of varying complexities Self-motivated; ability to execute with urgency under minimal supervision Identifies, understands and proactively mitigates technical/product risk Ability to communicate highly technical information in a clear and easy-to-understand way (both verbally and in writing) Demonstrated strong business acumen Team leadership experience; inspires and motivates others toward a shared purpose Strong collaborative skills; operates with an enterprise mindset; influences colleagues to achieve cross-functional alignment Advanced statistical analysis; experience using Minitab preferred Demonstrated understanding of advanced engineering principles and practices Design Control knowledge Experience with complex experimental design Product development experience, specifically in developing devices used in Plastic & Reconstructive Surgery (e.g. tissue expanders and breast implants) Knowledge of trends, techniques and technologies / products used in Plastic & Reconstructive surgery Experience using Finite Element Analysis (FEA) / Computer-Aided Design (CAD) programs Microsoft Office Suite including Word, Excel, PowerPoint, Visio, Project and Outlook Business Travel Role requires frequent domestic and international travel (Upto 25%)
Salary Range:
$200K -- $250K
Minimum Qualification
Technical Product ManagementEstimated Salary: $20 to $28 per hour based on qualifications.

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