The Senior Systems Engineer will actively contribute to the design and development of medical devices, collaborating closely with other systems engineers and cross-functional team members. This role involves defining, designing, and participating in the overall development of system architecture, design control elements, and integration efforts for new products. The Senior Systems Engineer will play a key role in translating user needs into system requirements and ensuring compliance with industry standards. Additionally, they will support risk management activities and contribute to comprehensive verification and validation processes.

PRIMARY RESPONSIBILITIES

1. Contribute to the definition, design, and development of system architecture and design control elements for new product development efforts
2. Participate in translating user needs into effective system requirements, ensuring compliance with current and emerging industry standards; support development of trace matrices
3. Support the safety, reliability, and performance assessment of complete systems and sub-systems, considering design tradeoffs and product-level specifications
4. Collaborate in risk management activities for new product development in compliance with ISO 14971
5. Contribute to the verification and validation of design outputs to ensure products meet intended design and performance specifications
6. Manage moderate development efforts, collaborating with internal and external partners
7. Participate in technical cross-functional project teams for new product design and development projects
8. Develop and maintain design history file and related documentation
9. Provide updates on project status and technical risk to Program Management
10. Support product launches, clinical, and commercial use of existing and new products

ADDITIONAL RESPONSIBILITIES

1. Mentor junior engineers
2. Support post-market (commercial) product-related investigations, CAPA activities, and other sustaining engineering activities
3. Identify opportunities for process improvement and contribute to the development of best practices
4. Champion and understand the needs of the patient, provider, and business through an unwavering commitment to patient safety and product quality
5. Support development of intellectual property critical to the company’s success
6. Perform other related duties as assigned

KNOWLEDGE AND SKILL REQUIREMENTS

• Typically 5+ years of experience (or equivalent combination of experience and education)
• Proficiency in medical device development, system engineering, and relevant technologies.
• Familiarity with FDA regulations and international standards for medical devices.
• Experience in contributing to risk assessments and implementing mitigation strategies in compliance with ISO 14971.
• Demonstrated ability to collaborate in managing development efforts, both internally and with external partners.
• Developing leadership skills to support and contribute to the guidance of less experienced team members.
• Effective communication and interpersonal skills to provide updates on project status and technical risks.

WORKING CONDITIONS

• Small office environment, electrical and mechanical prototyping labs.
• Ability to effectively work in a "virtual environment" at home or at a centrally located office
• Comfortable and productive working in and contributing to small engineering teams.
• Manufacturing environments typical of assembled electrical medical devices
• Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs
• Periodic travel, such as supplier visits, can usually be well planned in advance.