Career Opportunities with Nihon Kohden Orange Med
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Current job opportunities are posted here as they become available.
The software design engineering manager is to be an integral member of the engineering management team. This role will be responsible for developing and overseeing the software team members, and all software development for new product designs and maintaining the software designs for existing products. The ideal candidate will have a combination of technical expertise and leadership skills to effectively manage a team and ensure timely deliverables.
Duties and Responsibilities
- Lead a team of software engineers and facilitate design, development, and maintenance of existing and new products, and software products.
- Promote and provide best practice guidance for software development lifecycles in accordance with FDA guidelines and ISO 62304.
- Assist in product and project management effort for software development activities, ensuring that resources, tasks, workflows and timelines are properly allocated and met.
- Collaborate and support Regulatory Affairs (RA) and Quality (QA) in the creation and maintenance of software-related activities for product registration, as well as other cross-functional teams as needed.
- Mentor and train team members to enhance their technical skills and promote career growth.
- Adhere to all company policies, procedures, and business ethics codes.
- Duties may be modified or assigned at any time based on business need.
Qualifications
- Bachelor’s degree in computer science or engineering, or a related field. Master’s degree preferred.
- Minimum of 10 years of experience in software development. Critical care medical devices preferred.
- Minimum of 10 years of direct experience with real-time embedded software development for high reliability critical care medical devices.
- Strong proficiency in C/C++ and multi-threaded software development.
- Experience with object-oriented architecture and design.
- Experience with the development and performance of unit level testing and code review required for high reliability software verification testing.
- Strong knowledge of FDA software documentation and test requirements for 510K submissions.
- Experience with training and mentoring team members.
- Excellent leadership and communication skills.
Working Conditions
Works in an office environment which includes laboratory and manufacturing areas. Occasional travel may be required. Works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.
Physical Requirements
Must be able to type using the keyboard of a computer. Must be able to talk, listen, and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.
Direct Reports
All the software design team members report to this position.
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