Position SummaryWe are seeking an experienced Senior Systems Engineer to support the development of advanced medical device technologies from concept through commercialization. As a key member of the Systems Engineering team, this role will collaborate closely with Research & Development, Clinical, Quality, Manufacturing, Software, Electrical, Firmware, and Mechanical Engineering teams to ensure successful product development and system integration.
The ideal candidate will have a strong background in systems engineering within a regulated medical device environment and experience translating clinical and business needs into engineering requirements, managing system-level risks, and leading verification and validation activities. This role requires a highly collaborative and self-directed engineer capable of leading multiple projects while ensuring the delivery of safe, effective, and high-quality products.
Essential Duties and Responsibilities- Translate clinical and customer needs into measurable engineering requirements and ensure traceability through verification and validation activities.
- Develop and maintain system requirements, specifications, and design documentation.
- Perform risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation planning.
- Lead cross-functional system integration efforts involving mechanical, electrical, firmware, software, and sensing technologies.
- Research, design, develop, prototype, and test system-level solutions.
- Develop verification and validation plans, protocols, and reports to demonstrate compliance with product requirements and regulatory expectations.
- Plan and execute system safety and reliability testing activities.
- Analyze test data and system performance to identify opportunities for improvement and ensure compliance with performance specifications.
- Collaborate closely with Software, Firmware, Electrical, Mechanical, Quality, Manufacturing, and Clinical teams throughout the product development lifecycle.
- Support design reviews, root cause investigations, technical assessments, and engineering decision-making.
- Perform cost and performance analyses for new and existing products.
- Develop and implement innovative tools, methodologies, and processes to improve engineering efficiency and product quality.
- Design experiments, test fixtures, and data collection methods to support product development and research activities.
- Lead multiple engineering projects and ensure timely execution of project deliverables.
Required Qualifications- Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline.
- Strong understanding of systems engineering principles and multidisciplinary product development.
- Experience developing system requirements, specifications, and engineering documentation.
- Experience performing verification and validation activities within a regulated environment.
- Knowledge of risk management methodologies and system-level hazard analysis.
- Proficiency with laboratory test equipment and measurement tools.
- Strong analytical, problem-solving, and troubleshooting skills.
- Excellent written and verbal communication skills.
- Ability to work independently and lead multiple projects simultaneously.
Preferred Qualifications- Experience in FDA Class III medical device development.
- Experience with active implantable medical devices.
- Familiarity with requirements management tools and processes.
- Knowledge of electronics, embedded firmware, battery-powered systems, RF circuits, sensors, and mechanical systems.
- Experience with low-power electronic systems.
- Firmware development experience.
- Prior experience with system architecture, integration, and reliability engineering.
- Experience working in a highly regulated medical device environment.
Regulatory and Quality System Knowledge- ISO 14971 - Medical Device Risk Management
- ISO 13485 - Medical Devices Quality Management Systems
- FDA Design Control Requirements (21 CFR Part 820)
- Active Implantable Medical Device Standards
- Medical Device Verification and Validation Practices
Work Environment- Office and laboratory-based engineering environment.
- Frequent collaboration with cross-functional engineering, quality, manufacturing, regulatory, and clinical teams.
- Participation in product development activities from concept through commercialization.
- Fast-paced environment supporting multiple concurrent projects.
Physical Requirements- Ability to remain in a stationary position while working at a computer and laboratory workstation.
- Ability to operate laboratory and testing equipment.
- Ability to communicate effectively with team members and stakeholders.
- Ability to occasionally move throughout office, laboratory, and manufacturing environments.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.
