Senior Product Development Engineer II

Integra LifeSciences•Plainsboro Township, NJ

About The Position

Changing lives. Building Careers. Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. SUMMARY DESCRIPTION Integra is a leader in applying the principles of tissue regeneration to the development of medical products for reconstructive, neurosurgical, and orthopedic procedures. Reporting to the Senior Director, R&D, employees in this role are typically technical professionals who have the skills and expertise in the research, development and commercialization in the development of medical products based upon a variety of platforms (synthetic, xenograft and allograft) for Tissue Regenerative applications. Employees in this role 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 position performing well-defined activities.

Requirements

Bachelor degree with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience or equivalent education and years of experience
A minimum of 4 years in development of medical devices.
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments
Primarily hands-on worker, with instruction or supervision of others secondary to own technical work
Recognized as a leader within the team
Manages and/or coordinates programs within the function
Must have strong interpersonal and organizational skills, possess multitasking capability, be computer literate, and be able to work independently.

Responsibilities

Understands and applies basic principles of Design Controls.
Lead and manage the Design Control process for Medical Device products.
Assists with exploratory research and the identification of new products.
Uses expertise to improve operational efficiencies and meet compliance requirements.
Presents interpretation of data and recommendations for next steps at in-house meetings.
Summarizes, interprets, reviews data, draws conclusions, and independently proposes next steps.
Manages processes and ensures that goals are achieved.
May act as team leader and/or mentor junior professionals.
Advises project team management of resources needed to accomplish scientific project.
Collaborate with Manufacturing 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.
Specify and execute project work with a small team and prepare Quality System-compliant documents for equipment, processes, product specifications, etc.
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 in planning and execution of Safety and Performance testing of products consistent with varying levels of regulatory and clinical requirements.
Establishes priorities, checkpoints, and timelines for experimental work in support project objectives.
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.