Summary:

The Senior Systems Engineer will play a key role in the full lifecycle development of innovative medical devices, from concept to commercialization. This individual will lead system design activities, translate user needs into technical requirements, and ensure compliance with relevant industry standards and regulations. The ideal candidate possesses a strong understanding of medical device development processes, risk management techniques, and systems engineering principles, along with excellent communication and collaboration skills.

Essential Duties & Responsibilities:

1. Lead system-level design: Define and document system architecture, including requirements, specifications, and design descriptions for complex medical devices.
2. Requirements engineering: Elicit, analyze, and document user needs and translate them into clear, concise, and testable system-level requirements. Manage requirements traceability throughout the product lifecycle.
3. Risk management: Lead and participate in risk management activities, including hazard analysis, FMEA, and risk mitigation planning. Ensure that potential hazards are identified and addressed throughout the design and development process.
4. Verification and validation: Develop and execute comprehensive test protocols for system-level verification and validation activities. Analyze test results and ensure that the device meets all defined requirements and performs as intended.
5. Collaboration: Work closely with cross-functional teams (software, hardware, mechanical, quality, regulatory, clinical) to ensure successful product development and integration.
6. Communication: Effectively communicate technical information to both technical and non-technical audiences. Create and deliver presentations, reports, and documentation to internal and external stakeholders.
7. Compliance: Ensure compliance with all relevant medical device regulations and standards, such as FDA regulations, ISO 13485, and IEC 60601.
8. Process improvement: Contribute to the continuous improvement of systems engineering processes and best practices within the organization.
9. Mentorship: Provide guidance and mentorship to junior engineers on systems engineering principles and methodologies.

Supervisory Responsibilities:

This person has no direct supervisor responsibilities.

Interaction:

The incumbent interacts extensively with various individuals and departments within the organization, acting as a central hub of communication and collaboration, including, embedded systems and software engineering, electrical and mechanical engineering, manufacturing, quality, regulatory and marketing and sales teams.

Education and Experience

• Bachelor's degree in Systems Engineering, Biomedical Engineering, or a related field (e.g., Electrical Engineering, Mechanical Engineering, Computer Science) is required
• A Master's degree in a relevant engineering field is preferred, demonstrating a deeper understanding of systems engineering principles and their application in the medical device industry.
• 8 years of relevant experience is required with 5+ years of experience in systems engineering, specifically within the medical device industry

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

• Design Controls: Thorough knowledge of design controls and their implementation throughout the product development lifecycle
• Risk Management: Expertise in risk management techniques, including hazard analysis, FMEA, FTA, and risk mitigation strategies
• Requirements Elicitation and Analysis: Skilled in eliciting, analyzing, and documenting user needs and translating them into clear, concise, and testable system-level requirements
• System Architecture Design: Ability to develop and document comprehensive system architectures, including block diagrams, interface specifications, and design descriptions
• Communication and Collaboration: Excellent written and verbal communication skills, with the ability to effectively communicate technical information to both technical and non-technical audiences. Strong collaboration skills to work effectively with cross-functional teams
• Problem-Solving and Critical Thinking: Strong analytical and problem-solving skills to identify and address complex system-level issues. Ability to think critically and make sound engineering judgments
• Technical Writing and Documentation: Proficiency in creating clear, concise, and well-organized technical documentation, including requirements specifications, design documents, test plans, and reports
• Medical device development: Proven experience in the full lifecycle development of medical devices, from concept to commercialization
• Systems engineering methodologies: Strong understanding and practical application of systems engineering principles, including requirements engineering, risk management, verification and validation, and system architecture design
• RA/QA compliance: Familiarity with relevant medical device regulations and standards, such as FDA regulations (21 CFR Part 820), ISO 13485, IEC 62304, and IEC 60601
• Risk management techniques: Experience with risk management techniques, including hazard analysis, FMEA, and risk mitigation planning
• Tools and technologies: Proficiency in requirements management tools, system modeling tools, and other relevant software applications
• Travel may be required (5-20%).

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds. May require being on one's feet and walking for extended periods of time.

Work Environment:

The work setting is consistent of a typical medical device manufacturing environment with production areas, offices, and cubicles.