Engineer II, R&D Systems - Wayne, NJ

Getinge•Wayne, NJ

5d•$100,000 - $105,000•Onsite

About The Position

The Systems Engineer will be responsible for providing technical input to a team of systems and cross-functional engineers. You will support the development, improvement, verification, and troubleshooting of on-market electromechanical medical devices, including hands-on work in the engineering lab to support testing, data collection, and root cause assessment. A key aspect of this role involves the use of tools such as Excel and 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, remediation, and investigation activities are compliant with internal development processes and regulatory requirements specifically 21 CFR 820.30.

Requirements

BS in Systems, Biomedical, Electrical, Software, or related Engineering discipline with 4+ years of related systems engineering, design controls, medical device, product development, engineering lab testing, or root cause investigation experience
MS or PhD in Systems, Biomedical, Electrical, Software, or related Engineering discipline with 2+ years of related systems engineering, design controls, medical device, product development, engineering lab testing, or root cause investigation experience
Demonstrated ability to work with moderate independence in regulated product development, system-level testing, troubleshooting, objective evidence collection, and root cause assessment.
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
Hands-on ability to work safely and effectively in an engineering lab environment to execute test setups, collect objective evidence, support troubleshooting, and contribute to root cause investigations.
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
Demonstrates a learning mindset, curiosity, and willingness to ask questions, seek feedback, and apply coaching from senior engineers and cross-functional partners.
Uses clear communication to share observations, document test results, raise concerns, and align with team members on assigned work.
Works collaboratively in a team environment, demonstrating reliability, accountability for assigned tasks, and openness to different technical perspectives.
Maintains attention to detail and follow-through when collecting data, documenting objective evidence, tracking action items, and escalating issues appropriately.

Responsibilities

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 Excel and JAMA to manage requirements, track progress, and ensure traceability throughout the project.
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 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.
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.
Drive product improvements based on data and feedback.
Ensure compliance with all relevant regulatory requirements and standards.