Sr. Engineer, Systems - Defined Term

Job Overview

The Sr. Systems Engineer will be responsible for providing technical input to a team of systems and cross-functional engineers. You will support the development and improvement of on-market electromechanical medical devices, ensuring that improved practices and industry standards are adhered to. A key aspect of this role involves the use of tools such as JAMA for requirements management and traceability, ensuring that all project deliverables meet the specified criteria. The ideal candidate will support implementation of changes and is capable of working with a degree of flexibility while maintaining the current product and driving improvements in our systems engineering practices. The systems engineer will ensure that development and remediation activities are compliant with internal development processes and regulatory requirements specifically 21 CFR 820.30.

Job Responsibilities and Essential Duties

• Support the development and improvement of on-market electromechanical medical devices, ensuring that solutions are scalable, maintainable, and meet regulatory requirements.
• Utilize tools such as JAMA to manage requirements, track progress, and ensure traceability throughout the project.
• Collaborate with cross-functional teams to define project scope, objectives, and deliverables.
• Participate in design reviews and provide constructive feedback to team members to ensure high-quality designs.
• Maintain the current product while implementing innovative solutions and improvements.
• Support the development and remediation of electromechanical medical devices, ensuring that solutions are scalable, maintainable, and meet regulatory requirements.
• Utilize tools such as JAMA to manage requirements, risk, track progress, and ensure traceability throughout the project.
• Drive product improvements based on data and feedback.
• Ensure compliance with all relevant regulatory requirements and standards.

Minimum Requirements

BS in Systems, Biomedical, Electrical, or Software Engineering with 5+ years related experience or advanced degree in lieu of experience.

Required Knowledge, Skills and Abilities

• Strong track record of supporting the development of electromechanical medical devices.
• Proficiency in using tools such as JAMA for requirements management and traceability.
• Strong understanding of medical device development methodologies and regulatory requirements.
• Excellent problem-solving skills and the ability to think critically and strategically.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with team members and stakeholders.
• Participate in technical meetings with cross-functional team members.
• Knowledge of requirements development, traceability, and allocation.
• Knowledge of medical device risk management, including ISO 14971:2012.
• Knowledge of ISO 13485:2016.
• Knowledge of design verification and validation concepts, including the planning and execution of system-level testing of medical devices.
• Medical Device experience including thorough understanding of Design Controls (21 CFR 820.30).
• Working knowledge of FDA and International Standards requirements as related to capital equipment.
• Experience with Requirements Management Tools (such as JAMA).
• Strong organizational and technical writing skills.
• Excellent written and verbal communication skills.

This is a "Defined Term" assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.