Senior Systems Engineer

Responsibilities

• Lead cross-functional team through the design control process.
• Complete DHF documentation deliverables including – Product Requirement Specification, System Architecture Document, System Hazard Analysis, Failure Modes and Effects Analysis.
• Collaborates with stakeholders to decompose User Need requirements into product level and subsystem level requirements.
• Lead the risk management process in compliance with ISO 14971.
• Strategizes and develops verification and validation test plans to ensure product requirement specifications are met.
• Covers testing activities with internal teams and external partners to ensure V&V testing deliverables are met.
• Develops and validates test methods to appropriately verify product level requirements.
• Actively performs system level verification testing to ensure systems meet product level requirements and standards.
• Lead investigations into complex technical issues or failures related to hardware/software sub-components.
• Apply advanced problem-solving techniques, such as root cause analysis (RCA) and failure mode and effects analysis (FMEA), to identify underlying causes and implement robust corrective actions.
• Share knowledge, best practices, and lessons learned from previous experiences to cultivate a culture of learning and excellence within the engineering team.

Requirements

• Expert knowledge on medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
• Proficiency in engineering tools (e.g., SolidWorks, Minitab).
• Demonstrated proficiency in scripting languages (e.g. Python, MATLAB) and other software languages.
• Strong problem-solving skills with the ability to conceptualize and develop innovative engineering solutions to complex technical challenges.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders at all levels of the organization.
• Prior proven ability to drive results and meet project timelines and milestones while maintaining high standards of quality and compliance.

Education & Experience

• Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering.
• Minimum 5 years of related experience or 3 years and a Master’s degree in engineering.
• Solid systems engineering experience across the entire product lifecycle, with proficiency in tools such as requirements management, change control, traceability analysis etc.
• Strong experience in risk management methodologies (e.g., FMEA, fault tree analysis) and their application to medical device development and regulatory compliance.
• Strong experience in managing product and subsystem-level requirements throughout the development process.
• Experience in conducting design verification and validation activities, including protocol development, testing, and documentation, in accordance with regulatory requirements.
• Experience in system architecture design and control system design.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Must be able to access all areas of the facility to determine needs.

Salary

$120,000 - $133,000