Engineer II, Systems - Wayne, NJ - Defined Term

Getinge•Wayne, NJ

5d•$100,000 - $105,000

About The Position

The Systems Engineer provides technical input to a team of systems and cross-functional engineers supporting the development, improvement, verification, remediation, and troubleshooting of on-market electromechanical medical devices. The role includes hands-on engineering lab work to support system-level testing, test setup execution, data collection, objective evidence collection, and root cause assessment for product issues, complaints, CAPAs, and design changes. The engineer uses tools such as Excel and JAMA for requirements management, progress tracking, and traceability, and supports implementation of changes while maintaining current products and driving improvements to systems engineering practices. Development, remediation, and investigation activities must comply with internal processes and regulatory requirements, including 21 CFR 820.30. This is a defined-term assignment expected to last approximately 12 months or until the project is complete. Defined Term employees are eligible for most benefits, including health insurance and paid time off. The salary range is $100,000–$105,000.

Requirements

Bachelor's degree in Systems, Biomedical, Electrical, Software, or a related engineering discipline and 3 or more years of related experience; alternatively, a master's or Ph.D. in one of these disciplines and 2 or more years of related experience.
Related experience may include systems engineering, design controls, medical devices, product development, engineering lab testing, or root cause investigation.
Ability to work with moderate independence in regulated product development, system-level testing, troubleshooting, objective evidence collection, and root cause assessment.
Strong track record supporting the development of electromechanical medical devices.
Proficiency with requirements-management and traceability tools such as JAMA.
Strong understanding of medical device development methodologies and regulatory requirements.
Knowledge of requirements development, traceability, and allocation.
Knowledge of medical device risk management, including ISO 14971:2012, and knowledge of ISO 13485:2016.
Knowledge of design verification and validation concepts, including planning and executing system-level testing of medical devices.
Hands-on ability to work safely and effectively in an engineering lab, execute test setups, collect objective evidence, support troubleshooting, and contribute to root cause investigations.
Medical device experience, including a thorough understanding of Design Controls (21 CFR 820.30).
Working knowledge of FDA and international standards requirements as related to capital equipment.
Strong organizational and technical writing skills.
Excellent written and verbal communication skills.
Strong problem-solving skills and the ability to think critically and strategically.
Ability to collaborate effectively with team members and stakeholders and participate in technical meetings with cross-functional team members.
Learning mindset, curiosity, and willingness to ask questions, seek feedback, and apply coaching.
Reliability, accountability for assigned tasks, openness to different technical perspectives, attention to detail, and follow-through in collecting data, documenting objective evidence, tracking action items, and escalating issues appropriately.

Responsibilities

Support development and improvement of on-market electromechanical medical devices, ensuring solutions are scalable, maintainable, and meet regulatory requirements.
Use tools such as Excel and JAMA to manage requirements, track progress, and maintain traceability throughout projects.
Work in the engineering lab to support system-level testing, troubleshooting, data collection, test setup execution, and root cause assessment for product issues, complaints, CAPAs, and design changes.
Collaborate with cross-functional teams to define project scope, objectives, and deliverables.
Participate in design reviews and provide constructive feedback to support high-quality designs.
Maintain current products while implementing improvements and innovative solutions.
Drive product improvements based on data and feedback.
Ensure compliance with relevant regulatory requirements, standards, and internal development processes.