Johnson & Johnson has agreed to sell the Codman Neurosurgery (CNS) business to Integra LifeSciences subject to customary closing conditions and regulatory approvals. This transaction is anticipated to close later this year 2017. Please be advised that should you be hired, upon completion of this transition, your employment and the position with Codman Neurosurgery will transfer to Integra LifeSciences
Codman Neuro, a member of the Cardiovascular & Specialty Solutions (CSS) Group within Johnson & Johnson, is recruiting for a Senior Electrical and Software Engineer located in Raynham, MA.
Codman Neuro is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by neurosurgeons to treat patients with conditions resulting from traumatic injuries to the brain and spine, congenital neurological disorders, and acquired neurological diseases. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
The Cardiovascular & Specialty Solutions (CSS) Group consists of five businesses serving the following healthcare areas: Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, and Reprocessing Services. The CSS Group is committed to delivering innovative, market-leading products, solutions and programs to address unmet customer and patient needs around the world.
The Senior Engineer will participate in projects of varying scope and complexity across all three franchises: Hydrocephalus, Operative Neurosurgery and Neurosurgery Critical Care with a focus on the Neuro Critical care franchise. The Senior Engineer will be responsible for the electrical and software aspects of a project, interacting with external design and development partners, participating on cross-functional project team 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 tradeshows, 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.
- This position is located in Raynham, MA and will require up to 15% travel.
DePuySynthes Products Inc (6149)Job Function
Engineering (Generalist)Requisition ID