Sr Engineer, Product Development

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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
Integra is a leader in applying the principles of textile engineering to the development of medical products for reconstructive applications. Reporting to the Director, Product Development and Quality Assurance, employees in this role are typically technical professionals who have the skills and expertise in the research, development, design assurance, and commercialization of medical products.
Employees in this role typically have specialized knowledge gained through wide exposure or experience in a specialized or technical field, in a technique that combines a broad grasp either of involved practices and precedents, or engineering theory and principles, or both.
They are typically team members with responsibility for delivering components of a larger process and may provide work instruction or supervision to lower-level positions performing well-defined activities.
Essential Duties and Responsibilities:

• Lead and manage the Design Control process of new or improved products in close collaboration with Project Management, RA, Marketing and Medical Affairs.
• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process and application FMEAs.
• Leads Design Reviews, Technical Reviews, Risk Reviews, and Gate Reviews in support of the Design Control and Risk Management Processes.
• Summarizes, interprets, reviews data, draws conclusions, and independently proposes next steps.
• Manages processes and ensures that goals are achieved
• Collaborate with internal and external Manufacturing partners to transfer developmental products into manufacturing, sharing responsibility for Verification & Validation
• Work with external vendors, consultants, and collaborators to facilitate project work
• Interact with customers to assure design requirements are established and met
• Develops a strategy and plan of execution using his/her scientific knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project
• Assists with exploratory research and the identification of new products
• Establishes priorities, checkpoints, and timelines for experimental work in support of project objectives
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
• Effectively applies broad scientific knowledge and shows a high level of scientific and technical proficiency in own field
• Demonstrates reasonable knowledge/expertise outside of own field.
• Employ interpersonal, communication and negotiation skills with all levels of personnel and management to facilitate information flow among team members

• Bachelor's Degree in Engineering (Biomedical, Mechanical, or Electrical) or Science (Biology).
• 5 years of experience in a Product Development role or similar for medical device.
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
• Demonstrates excellent organizational, verbal and written communication skills
• Proficient with the MS Office Suite, and statistical software.
• Must be able to work independently with minimal supervision.
• Able to prioritize projects and manage assigned Quality resources to meet organizational goals and objectives