Job Overview:The Director of Software Engineering will be responsible for overseeing all software development activities for our medical devices. This role requires a deep understanding of the medical device industry, including regulatory requirements, software development lifecycle, and quality assurance standards. The ideal candidate will have a strong background in C/C++ programming and a proven track record of leading engineering teams in the successful delivery of complex projects.
Key Responsibilities:
- Lead and manage the software engineering team, providing technical guidance, mentorship, and career development.
- Oversee the entire software development lifecycle, including planning, design, implementation, testing, deployment, and maintenance.
- Collaborate with cross-functional teams, including hardware engineering, quality assurance, regulatory affairs, and clinical affairs, to ensure seamless integration and compliance of software components.
- Develop and implement software development processes and best practices to enhance productivity, quality, and efficiency.
- Drive innovation by staying current with industry trends, emerging technologies, and best practices in software engineering and medical devices.
- Manage project timelines, budgets, and resources to ensure on-time and within-budget delivery of software projects.
- Participate in risk management activities, including the identification, assessment, and mitigation of software-related risks.
- Prepare and present technical documentation, reports, and presentations to stakeholders, including senior management, regulatory bodies, and customers.
- Foster a culture of continuous improvement, collaboration, and excellence within the software engineering team.
Qualifications:
- Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field. Advanced degrees or certifications in medical device software development are a plus.
- Minimum of 10 years of experience in software engineering, with at least 5 years in a leadership role within the medical device industry.
- Strong proficiency in C/C++ programming and a solid understanding of software architecture and design principles.
- In-depth knowledge of medical device regulations and standards, including ISO 13485, IEC 62304, and FDA guidelines.
- Proven experience in managing the software development lifecycle and leading teams in the delivery of complex software projects.
- Excellent problem-solving skills and the ability to make sound technical decisions under pressure.
- Strong interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to non-technical stakeholders.
- Experience with risk management, quality assurance, and validation/verification processes in the context of medical device software.
- Demonstrated ability to drive innovation and stay current with industry trends and emerging technologies.
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