Engineer II

• We are seeking a Systems Engineer II to join a Device and Combination Product Development R&D team. The engineer will contribute to the development and launch of innovative drug-device combination products.
• The role will integrate multiple engineering disciplines to support robust, safe, compliant, and patient-focused product design and performance.

Responsibilities:

• Develop and maintain Design History Files (DHF) and Design Control documentation in compliance with applicable regulations.
• Define User and Stakeholder Needs and perform Use Case Analysis.
• Develop and maintain Design Inputs, System/Sub-System Requirements, and requirements traceability.
• Perform Standards Coverage Analysis.
• Support System Architecture and System Integration activities.
• Integrate third-party development activities into the overall product development process.
• Develop and support Risk Management Plans, risk assessments, and risk reporting.
• Conduct or support FMEA and Use Error Risk Assessments.
• Support integration of drug product development activities.
• Support design verification and validation activities.
• Collaborate across engineering and cross-functional teams to meet project objectives.
• Provide technical leadership and influence stakeholders within a matrixed organization.
• Support implementation and improvement of Systems Engineering principles.
• Ensure system design and documentation meet applicable safety, quality, and regulatory requirements.
• Identify project risks and develop appropriate mitigation strategies.
• Support project schedules, priorities, and competing deliverables.
• Apply strong analytical and decision-making skills to resolve technical challenges.

Qualifications:

• Bachelor's degree: Typically, 510 years of relevant experience.
• Master's degree: Typically, 37 years of relevant experience.
• PhD: Typically, 14 years of relevant experience.
• Strong theoretical and practical understanding of the relevant scientific/engineering discipline.
• Experience developing products within a regulated industry, particularly Medical Device, Pharmaceutical, Biotech, or Combination Product environments.
• Experience with Design Controls, DHF, requirements definition, traceability, risk management, and product architecture.
• Strong written and verbal communication skills.
• Experience preparing technical, scientific, or regulatory documentation.
• Demonstrated technical leadership and ability to influence and negotiate internally and externally.
• Strong analytical, problem-solving, organizational, and decision-making skills.
• Self-driven, proactive, and comfortable working in a cross-functional/matrixed environment.
• Regulatory & Industry Standards

Experience with relevant standards and regulations, including:

• IEC 60601.
• ISO 14971.
• IEC 62304.
• ISO 11608.
• ISO 11040.
• ISO 13485.
• 21 CFR 820.
• MDR.
• FDA/regulatory requirements for medical devices and combination products.

Top Skills Required:

• Design Controls experience in Medical Device or Combination Product development.
• Systems Engineering experience, including Design Inputs and Traceability Matrix.
• Risk Management experience, including Risk Management Plans, FMEA, and risk assessments.
• Strong written and verbal communication skills.
• Experience working in a regulated product-development environment.