Position: The experienced Software Engineering Manager supports our rapidly growing domestic and international product development, sourcing, and manufacturing business.
Nature of Role: Reporting to the Director of Engineering, the Software Engineering Manager is responsible for planning, implementing and maintaining costs, methods and employees related to the development of software.
The software manager is a key leadership position. In addition to leading the Software team, the manager is responsible for development of software embedded in products including medical products. This may include: medical and non-medical products and/or automated testing / manufacturing processes used to build them; the software development process, software testing, as well as the evaluation of new technology, tools, and development practices. As appropriate, the software manager will also ensure compliance with medical device regulations and device standards in this regulated industry. The manager will oversee a group of professional embedded software engineers and software test engineers while participating in technical work.
Requirements: An effective leader preferably holding a BS/MS degree in computer science, computer engineering, or electrical engineering coupled with 5+ years of software development experience within the medical device/equipment industry, and 4 + years leading, supervising, or managing software engineers. Strong software development skills from requirements development through support are necessary. Knowledge of FDA QSR Regulations (21 CFR 820), ISO 13485:2003 (Quality System), ISO 14971:2007 (Risk Management), and IEC 62304:2006 (Medical Device Software Lifecycle Processes) is essential. Experience with revision and issue tracking software is desired.
Our fast-paced environment demands the ability to manage multiple projects within the discipline and deadlines. High-energy, self-starters with the following qualities:
- Successful communication skills, business acumen and assertive decision-making ability
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency
Responsible advising teams of following Ximedica’s processes and procedures related to software development, including but not limited to:
- Leads and mentors software team while providing employee development and teambuilding .
- Responsible for managing the capacity of the engineering department.
- Works with the Director of Engineering and Human Resources to identify suitable candidates
- Responsible for final selection of candidates for hire
- Works within the resource management process to identify and resolve gaps in capacity
- Acting as independent reviewer at key points in programs, including technical reviews (code reviews), design reviews, phase reviews and risk management reviews and advising on potential corrective action.
- Ensures adherence to established software development policies and procedures, targeting reproducible and high quality output by participating in the overall program development process.
- Advises proposal authors on scope of work and level of effort required for software related activities.
- Further advises Program Management on schedules and risks which may affect delivery timetables.
- Works with the Director of Engineering to determine needed budget and ensure proper execution of personnel training and tools inventory to ensure proper discipline (department) capability.
- Responsible for performance appraisals of software personnel; works with Human Resources to make disciplinary decisions.
- Creates individual professional development plans aligned with Ximedica's growth and business direction.
- Employs/applies/develops standard development methodology and best practices.
- Responsible for recommending, implementing and/or overseeing new technologies to insure Ximedica is a leader in software development.
- Maintain duties and responsibilities of a Senior Software Engineer as a percentage of overall workload.