Product Development Engineer
Billerica, MA

Job Description

Overview

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 4,400 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

* Provides technical leadership in software development within project teams
* Develops software according to Integra's Software Development Process.
* Design, develop, review, and debug software.
* Supports design verification and validation activities.
* Contributes to and executes engineering schedules and plans.
* Instructs engineers and technical support staff on engineering test and build requirements.
* Work as part of multi-functional team with other hardware engineers and support functions.
* Prepares cost and time estimates for engineering and project schedules.
* Provides written reports and engineering documentation as necessary.
* Executes tactical implementation of strategic plans.
* Assures compliance with company Standard Operating Procedures and policies.
* Participates in team decision making.
* Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards including the IEC 62304 standard for software development in medical devices.
* Stays informed about applicable new rules, regulations, and standards, specifically with respect to software.
* Writes engineering test protocols for testing of component parts and integrated systems.
* Prepares weekly progress reports on projects.
* Prepares verbal presentations for various company meetings.
* Develops and writes specifications for components/systems, product, processes, and packaging/labeling.

Qualifications

* Bachelor's degree in Computer Science, Electrical Engineering, or other related scientific discipline; Master's degree or higher preferred.
* 3-5 years experience in software development, preferably in the medical device industry.
* Solid programming experience in C#, C, and C++ is a must.
* Experience in hands-on development and troubleshooting on embedded devices is desired.
* Familiarity with software configuration management tools, defect tracking tools, and document control systems (Agile) preferred.
* Excellent knowledge of embedded OS design concepts and user interface design, preferably on Windows systems desired.
* Experience with Windows embedded operating systems, .NET, WPF desired.
* Knowledge of IEC 62304 based software development will be a plus.
* Experience working with Visual Studio or other IDE desired.
* Strong verbal and writing skills needed.
* Knowledge of serial, I2C, or other communication protocols will be a plus.