System Engineer

The Systems Engineer will provide technical leadership and be responsible for the successful realization of new product releases and sustaining engineering activities. This role involves translating user needs into system requirements, leading system design and integration, and ensuring compliance with regulatory and quality standards for medical devices.

• Provide overall technical leadership for new product development and sustaining engineering efforts.
• Translate user needs into system and subsystem requirements, manage requirements throughout the product lifecycle, and assess feasibility of technical solutions.
• Lead system design, architecture development, and system integration activities.
• Support New Product Introduction (NPI) initiatives through innovation and high-quality engineering solutions.
• Act as technical liaison to program and cross-functional teams.
• Lead defect management, risk management, and design review activities.
• Ensure compliance with regulatory, quality, and safety standards applicable to medical devices.

• Bachelor’s degree in Engineering or a related field.
• Experience leading product development efforts in medical devices or other regulated industries.
• Proven ability to lead teams in solving complex technical problems.
• Experience defining and simulating human-device interactions and use conditions.
• Experience with electronic requirements management tools (preferably IBM DOORS).
• Minimum 5 years of engineering or R&D experience in a quality-focused environment.
• Minimum 3 years of experience in a Systems Engineering role with responsibility across electrical (analog and digital), mechanical, firmware, and software disciplines.
• Strong requirements and technical specification writing skills.
• Demonstrated understanding of U.S. and international regulatory requirements for regulated products.
• Strong cross-functional collaboration and communication skills.
• Excellent verbal, written, and presentation skills.
• In-depth knowledge of risk management per ISO 14971.
• In-depth knowledge of product development and testing to IEC 60601-1 (Safety) standards.
• In-depth knowledge of product development and testing to IEC 62366 (Usability) and EMC standards.

• Strong understanding of U.S. and international medical device regulations.
• Experience developing product reliability plans.
• Knowledge of product development processes and best practices.
• Knowledge of verification and validation (V&V) testing processes.
• Electrical or software development experience.
• Master’s degree in Engineering or a related field preferred.