Integra LifeSciences Product Development Engineer - Electrical and Software in Mansfield, Massachusetts
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.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Product Development Engineer II will be responsible for the electrical and software aspects of a project, interacting with external design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting and communicating testing activities.
Fulfill design control requirements including the creation of detailed electrical/software specifications and requirements, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines.
Work with development partners and other external vendors to support project plan deliverables.
Coordinate and participate in the development of electrical/software architectures for medical devices.
Coordinate, review and approve electrical/software documentation created by external partners, including product requirements, schematics, code, verification and validation test protocols and reports.
Prepare and lead Design Reviews, Technical Reviews, and Peer Reviews.
Provide support for field-based Sales Team and other Commercial partners.
Partner with Downstream Marketing, Sales and key external stakeholders to identify unmet clinical/surgical needs; evaluate options; and provide sound engineering solutions.
Collaborate with internal and external partners to launch new products.
Attend industry trade-shows, professional education events, and other company-sponsored events to provide product training and support to customers as needed.
Bachelor’s Degree in engineering is required, with preference for Electrical and Computer Engineering.
Advanced Degree (MS) in Electrical Engineering, Computer Engineering, or equivalent is preferred.
Black Belt certification is desired.
A minimum of 5 years of engineering experience is required
Majority of the experience encompasses of electrical design of low power devices and real-time software for embedded systems is required.
Experience in medical device product development is preferred, with emphasis in hand held units, monitoring devices and/or neurosurgery field.
Knowledge of medical device product development in a regulated environment (e.g., FDA, ISO) is required
Experience with Electrical safety testing is required (i.e., 60601-1).
Experience with Medical Software life cycle processes is required (i.e., 62304).
Real-time embedded software experience is a plus (e.g., Java, C, C++, Linux OS, QNX OS).
Experience with x86 or ARM microprocessors, PIC microcontroller, and CPLD firmware is a plus
Knowledge of device drivers is a plus.
Experience with electrical CAD tools including schematic capture, simulation and PCB layout is a plus.
Experience with low power RF technologies and connectivity to smart devices is a plus.
Demonstrated detailed design analysis and statistical analysis for a robust and manufacturable device is required.
Ability to be both a strong team player as well as team leader is desired.
Prior experience working with project teams bringing products from concept to launch is preferred.
Strong communication skills are required; the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/ or teams.
Vacancy ID 2018-26092
Position Type Regular Full-Time
Category Product Development