Manager, Software Engineering

We're committed to being Your Future, Your Solution by helping accelerate your career! To learn more about this opportunity, contact TJ Markwas at tmarkwas@saigepartners.com or 319-450-0380, or schedule a meeting at TJ's Calendly link.

Software Engineering Manager

Position Overview:

As a key leader in R&D Product Development, the Software Engineering Manager will deliver cutting-edge, technology-driven solutions to meet customer and patient needs. You will oversee product programs, foster team development, and drive continuous process improvement. Serving as the design owner, you will ensure compliance with customer, business, and regulatory requirements by translating product requirements into effective design outputs and managing technical risks.

This role requires close collaboration across multiple functions, including Systems Engineering, Firmware, Hardware, Marketing, Regulatory Affairs, Quality Assurance, and Project Management.

Key Responsibilities:

• Provide technical leadership for complex technologies in Windows and Linux environments, focused on Medical Devices in a regulated setting.
• Align software strategy with business goals, driving continuous improvement in systems, products, and processes.
• Develop technology roadmaps in line with business strategy and foster innovation by leading the creation of Intellectual Property (IP).
• Oversee design, development, implementation, and verification of device software and connectivity in compliance with regulatory standards.
• Lead and mentor the Software Engineering team, ensuring talent development, coaching, and career growth.
• Build a high-performing team by identifying required competencies and developing strategies to recruit and nurture talent.
• Work with Program Management to prioritize and allocate resources for programs and projects.
• Collaborate with Principal Architects and adjacent leaders to ensure technical, functional, and operational product requirements are met.
• Lead test strategy development for automation, software verification, and validation.
• Drive DevOps strategies that enhance engineering throughput and software quality.
• Provide technical guidance through trade-off analysis to solve complex product challenges.
• Lead cross-functional decision-making, balancing technical and schedule risks while meeting cost and lifecycle requirements.
• Ensure system integration, meeting user and system requirements, and demonstrating traceability through validation and verification processes.
• Conduct risk, hazard, and timeline analyses to evaluate design concepts and solutions.
• Manage cross-system design activities and interface directly with product leadership to report on project status and issues.
• Support the development of high-quality documentation throughout all phases of product development, including design specifications and test plans.
• Ensure regulatory compliance for all developed products under FDA, EU, PMDA, and other global regulatory bodies.
• Play a pivotal role in driving a culture of engineering excellence and quality.

Qualifications:

• Bachelor’s Degree in Computer Science, Computer Engineering, Electrical Engineering, Physics, or a related scientific field.
• 8+ years of software engineering experience in R&D or product development, preferably in medical devices or regulated industries.
• Proven experience leading the full Software Development Life Cycle through to product launch.
• Familiarity with Software Design and Development processes in compliance with Quality Management Systems (QMS).
• 2+ years of direct or indirect people leadership experience.
• Experience working with global cross-functional teams.
• Strong background in Enterprise Architecture for complex systems, especially those with connectivity.
• Proven skills in technical risk management and mitigation.
• Strong mentoring and coaching abilities with a track record of motivating teams.
• Excellent communication and influence skills, with the ability to gain buy-in for key initiatives.
• Ability to manage multiple projects simultaneously, balancing resources, timing, and quality.

Preferred Qualifications:

• Advanced degree in Computer Science, Computer Engineering, or a related field.
• 10+ years of industry experience with full Product Life Cycle expertise.
• 5+ years of experience developing Medical Device Software in a regulated field.
• Experience developing Intellectual Property.
• Proficiency with C# .NET, Azure DevOps, Python, and related environments.
• Knowledge of clinical radiology terminology and QSR, ISO/EN, and quality system standards.

Additional Information:

• Adheres to all company policies and ethical standards, ensuring team compliance.
• Ability to travel up to 10%.

Saige Partners is one of the fastest-growing technology and talent companies in the Midwest. We believe in Building Careers, Not Jobs by fostering a company culture where people are the most valuable asset.

To learn more about this opportunity or explore other openings, visit Saige Partners Careers.