Integra LifeSciences Senior Engineer, Product Development in Irvine, California
Senior Engineer, Product Development
US–CA–Irvine, Vacancy ID2021-37082
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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. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
The Senior Engineer, Product Development is a professional that applies 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Manage all phases of Product Development, including conception, design, specifications, prototyping, verification, validation, risk management, project management, process development, management updates and design transfer.
Lead cross functional teams.
Apply engineering knowledge and expertise to resolve crucial issues and/or unique conditions.
Develop next generation neurological medical devices.
What are we looking for?
DESIRED MINIMUM QUALIFICATIONS
B.S., M.S., PhD degree in an engineering discipline with 5 or more years of applied experience.
Experience developing medical devices from concept through commercial release.
Demonstrates mechanical skills.
Demonstrates organizational and project management skills.
Proficiency in data analysis and data analysis software (Minitab, Excel).
Strong understanding of FDA QSR and ISO 13485 medical device regulations.
Proficiency in Computer Aided Design software, such as Solidworks or Onshape.
Proficiency in Risk Management (UFMEA, DFMEA, PFMEA)
Professional communication skills, verbal and written.
Advanced troubleshooting / problem solving skills.
Experience working with operations to ensure smooth product transitions from design to manufacturing.
Experience utilizing a wide range of fabrication techniques.
Proficiency applying ASME Y14.5 drafting standards.
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required.
Computer aided design software (Onshape, Solidworks)
Project management software (Microsoft Project)
Basic shop tools (Drill press, 3D printer, lathe, mill etc.)
Basic electronic tools (multimeter, solder, wire cutters)
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.
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.
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.
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