KH
Engineer II
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
1 month ago
- Risk Management
- FMEA
- System Design
- IEC
1 month ago
- 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.
- 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.
- Bachelor's degree: Typically, 5–10 years of relevant experience.
- Master's degree: Typically, 3–7 years of relevant experience.
- PhD: Typically, 1–4 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
- 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.
- 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.
Engineer II · Katalyst Healthcares & Life Sciences