Software Architect​/Program Manager - Neuromodulation

Software Architect/Program Manager - Neuromodulation

Location:

Twin Cities, MN

Compensation: $200k + Equity

Join a medical device start-up seeking an experienced Software Engineer to establish, manage and lead the company's software engineering function, oversee the design and development of software for an advanced implantable neuromodulation system, and serve as a technical contributor to the software design and development. The position will initially report to the CEO and will collaborate with other members of the technical leadership team.

• Develop software architecture and requirements from system requirements and use cases.
• Develop software system documentation, including requirements, risk analyses, and verification and validation (V&V) test strategies and plans.
• Develop company-wide software engineering practices and procedures in accordance with international and regulatory standards.
• Develop applications with existing Bluetooth connected system components and cloud-based backend components.
• Analyze existing software elements, including licensed software technology, to determine system fit for use.
• Contribute to software implementation, as well as manage and oversee software development partners.
• Lead design reviews, code reviews, software status meetings and software project management activities.
• Collaborate closely with all engineering disciplines, both development and quality, on project and partner requirements.
• Collaborate with the management team to define and accomplish project objectives. Present at technical leadership and management team meetings, as required.
• Collaborate with clinical affairs to support clinical trials.
• Support system regulatory submissions with technical documentation and strategic input.

• BS, MS or PhD in electrical engineering, computer engineering, computer science or other relevant degree in an engineering or software-related discipline.
• 10+ years professional experience in implantable medical device development, with a minimum of 5 years in a software engineering leadership role.
• Deep experience with active implantable neuromodulation systems, including typical software and electrical characteristics of implantable neurostimulators and external instruments.
• Expertise in the medical device software development lifecycle, software documentation and deliverables. Expertise in configuration management, software anomaly tracking, automated testing, and software verification and validation.
• Successful technical project management skills, including the ability to work quality and regulatory functions.
• Ability to build and maintain strong relationships with internal and external stakeholders.
• Deep knowledge of ISO 62304, ISO 14971, and other industry standards applicable to medical device software development.
• The candidate must have strong interpersonal skills and demonstrate excellent technical expertise and leadership, as well as strong written and verbal communication skills.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.