Manager, Systems Engineering

About the role

The Systems Engineering Manager facilitates the execution of strategic product development objectives by providing both technical leadership and direct systems engineering contributions across the product development lifecycle. This role leads a small team of Systems Engineers while actively participating in system architecture, requirements development, risk management, system integration, and verification activities. The Systems Engineering Manager partners closely with cross-functional teams to translate customer, clinical, business, and regulatory requirements into robust medical device solutions while continuously improving systems engineering processes, tools, and best practices.

Responsibilities

• Leads and develops the Systems Engineering team.
• Generates and analyzes system architectures, requirements, and risk management artifacts.
• Communicates and coordinates with cross-functional teams.
• Provides technical leadership for system integration, verification, validation, and problem resolution.
• Advises teams on systems engineering tools, methods, and standards.
• Monitors work to ensure technical quality, effective execution, and schedule adherence.
• Conducts performance reviews, provides performance feedback, establishes development goals, allocates resources, and supports career growth.

Requirements

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Software Engineering, or a related discipline with a minimum of 10 years of relevant experience.
• Demonstrated experience leading cross-functional engineering teams.
• Direct experience with requirements development, traceability management, risk management, system architecture, and verification activities.
• Strong written and verbal communication skills.

Qualifications

• Previous people management experience.
• Direct experience developing regulated medical devices.
• Strong knowledge of ISO 14971, IEC 60601 series, IEC 62304, IEC 62366, and FDA design control requirements.
• Experience with requirements management and traceability tools such as IBM DOORS.
• Experience supporting FDA, EU MDR, and international regulatory submissions.

Skills

• Passion: Contagious excitement about the company – sense of urgency.
• Commitment to continuous improvement.
• Integrity: Commitment, accountability, and dedication to the highest ethical standards.
• Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service.
• Action/Results: High energy, decisive planning, timely execution.
• Innovation: Generation of new ideas from original thinking.
• Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
• Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence others. A critical skill for pressure situations.