Systems Engineer II Medical Devices ​/ Combination

Systems Engineer II Medical Devices / Combination Job Summary

The Engineer II will support systems engineering activities for the development of medical device and combination products within a regulated research and development environment. This role will contribute to patient focused product design, system integration, design control activities, requirements development, traceability, and risk management. The engineer will collaborate with cross functional engineering teams to ensure product designs and documentation meet applicable safety, quality, and regulatory requirements.

The position requires strong analytical abilities, effective communication, and the ability to manage multiple priorities in a matrixed organization.

• Manage Design History File activities and develop Design Control documentation in accordance with applicable regulatory requirements.
• Lead and support user and stakeholder needs definition, use case analysis, requirements definition, and requirements traceability activities.
• Develop and maintain system and subsystem requirements, system architecture, integration activities, and standards coverage assessments.
• Support risk management planning, system risk assessments, use error risk assessments, FMEA activities, and development of appropriate risk mitigation strategies.
• Coordinate engineering activities across multiple disciplines and support integration of third party development activities.
• Support design verification and validation activities to ensure product performance, safety, and regulatory compliance.
• Provide technical leadership within assigned areas and effectively influence cross functional teams and stakeholders.
• Support project planning, identify project risks, develop mitigation plans, and manage competing priorities.

• Bachelor’s degree or equivalent education with typically 5 to 10 years of relevant experience.
• Product development experience within a regulated industry such as medical devices, pharmaceuticals, or biotechnology.
• Hands on experience with Design Control processes for medical devices or combination products.
• Experience with systems engineering principles, including design inputs, requirements definition, and traceability matrices.
• Experience with risk management activities including Risk Management Plans, FMEA, and risk assessments.
• Experience working within regulated environments and familiarity with applicable quality and regulatory requirements.
• Strong written and verbal communication skills with the ability to influence and collaborate across cross functional teams.

• Master’s degree or equivalent advanced education.
• Experience with medical device and combination product development.
• Knowledge of IEC 60601, ISO 14971, IEC 62304, ISO 13485, 21 CFR 820, and applicable medical device regulations.
• Experience with user and stakeholder needs definition, product architecture, standards coverage analysis, and design validation.
• Experience coordinating third party development activities.
• Experience providing technical leadership within a matrixed engineering organization.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)