This job has expired

Sr Engineer, Product Development

Employer
Integra LifeSciences
Location
Plainsboro, NJ
Closing date
Jun 24, 2022

View more

You need to sign in or create an account to save a job.
Sr Engineer, Product Development

USNJPlainsboro, Vacancy ID2022-41778

Career Home Job Search Results Sr Engineer, Product Development

Changing lives. Building careers.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integras common stock is listed on The NASDAQ Stock Market under the symbol IART.

RESPONSIBILITIES

Responsibilities

Reporting to the Director, R&D, the Sr Product Development Engineer is responsible for managing all aspects of design development and testing for medical devices and biologics at Integra in compliance with the FDA Quality System Requirement. These duties include developing medical device designs and prototypes, detailed specifications and tolerances, and test methods. They will apply knowledge of engineering to lead and technically support the development of medical devices. They utilize knowledge and expertise to resolve critical issues and successfully commercialize products. Employees in this role have had success as technical members of cross functional project teams and have the skills necessary to lead projects.
  • Lead research and development activities using knowledge of anatomy/physiology, biomaterials, and basic engineering principles
  • Develop design testing methods and procedures; conduct prototype and design verification as directed
  • Prepare and present technical updates to the Tissue Technology leadership team
  • Provide written documentation and reports for testing
  • Mentor and direct other engineers in design development and testing for medical devices and biologics
  • Participate in in-vitro and in-vivo studies, including animal and human evaluations as part of product development
  • Update estimates, budgets, schedules, reports, and design control documents based on revisions and changes to the product designs and research projects
  • Investigate design changes and failures, product complaints, and non-conformances; report findings and recommendations in company systems for corrective and preventive action
  • Assist in preparing and maintaining the departmental policies, procedures, and manuals
  • Submit new ideas for patent filing
  • Prepare Failure Mode Effects Criticality Analysis (FMECA) and risk assessments for product and processes
  • Assist in process/product validations of new and modified designs and processes
  • Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the companys products
  • Generate test plans and reports in support of regulatory submissions
  • Interface with Manufacturing, Quality, Regulatory, Research and Development, Sales, Marketing, and outside vendors to accomplish assigned tasks
  • Performs related duties as assigned

QUALIFICATIONS

What are we looking for?

Qualifications

Qualifications:
  • Minimum of a Bachelors degree in an Engineering discipline, or possess the equivalent combination of education and experience
  • Minimum of 7 years of medical device industry experience, preferably in a product development engineering position
  • Experience with tissue-based technologies or experience developing or refining biological implantable materials
  • Experience in extracellular matrix processing with an understanding of the biological performance of collagen-based membranes in soft tissue, including but not limited to xenografts, allografts, natural matrices, and regenerative tissue (processing of materials)natural, not synthetic desired
  • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products
  • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives
  • Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing
  • Working knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices
  • Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes, secondary operations, and assembly of medical components and devices
  • The ability to travel up to 15%

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas big and small are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) |EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

Please see our Privacy Policy (https://www.integralife.com/privacy) . Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to our Terms of Use (https://www.integralife.com/terms) . You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Integra Life Sciences. Contact Us (https://www.integralife.com/contact) with any questions or search this site for more information.

Copyright 2020 Integra LifeSciences Corporation. All Rights Reserved.
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert