Systems Engineer

Required Technical/Functional Skills

• Strong knowledge of systems engineering principles, including experience with electro-mechanical systems integrated with software.
• Certification in Systems Engineering or Reliability is highly desirable.
• Proven experience in electromechanical system development, preferably in medical devices or medical-grade water devices.
• Demonstrated ability to deliver projects/products within budget, schedule, and defined quality/product requirements.

Roles & Responsibilities

• Lead and perform systems engineering activities across one or more products at various stages of the product lifecycle—from new product development to post-market surveillance.
• Gather and analyze requirements from diverse sources, including standards, user needs, regulatory requirements, quality, human factors, manufacturing, and service.
• Conduct impact assessments for any proposed design, material, or process changes, including field/service or manufacturing observations; develop recommended mitigations with rationale.
• Coordinate and manage interrelated systems engineering activities across multiple functions while balancing human and financial resources amidst changing priorities.
• Assist in identifying, planning, and allocating tasks, activities, and resources for systems engineering efforts.
• Facilitate understanding of interrelationships between requirements, risk, and reliability throughout product development.
• Apply working knowledge of FMEAs and relevant standards to systems engineering tasks.
• Develop design concepts and research methodologies to meet both current and future customer and business needs for a given product or process domain.
• Translate clinical and user needs into actionable product requirements and realization strategies.
• Create, maintain, and manage Design History File (DHF) elements in compliance with applicable regulatory standards.
• Influence stakeholders and cross-functional teams effectively to ensure alignment with project objectives.
• Leverage domain knowledge of technology, processes, and therapy areas to drive solutions and deliver product design from a systems perspective.

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Electrical, or Biomedical Engineering or related field.
• Minimum 10 years of experience in systems engineering, preferably in the medical device industry.
• Strong analytical, problem-solving, and communication skills.
• Familiarity with regulatory standards applicable to medical devices (e.g., ISO 13485, IEC 60601, FDA requirements) is a plus.

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