Bachelor's degree with 5-10 years experience, or Master's with 3-7 years, or PhD with 1-4 years.
Strong understanding of scientific or engineering principles in related fields.
Experience in regulated environments such as Medical Device or Pharmaceutical.
Proficient with Design Controls, Design History Files (DHF), and risk management.
Excellent written and verbal communication skills.
Demonstrated technical leadership and negotiation skills.
Ability to work in a cross-functional and matrixed environment.
Responsibilities
Develop and maintain Design History Files (DHF) and related documentation.
Define user and stakeholder needs, conducting Use Case Analysis.
Create and manage Design Inputs and System Requirements documentation.
Perform Standards Coverage Analysis to ensure compliance.
Support System Architecture and Integration tasks.
Integrate third-party development into product development.
Conduct risk assessments and create Risk Management Plans.
Benefits
Opportunities for professional growth and development.
Engagement in innovative drug-device combination product initiatives.
Collaborative work environment with cross-functional teams.
Impact on patient-focused product design and performance.
Exposure to industry standards and regulatory requirements.
Full Job Description
Job Description:
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.
pply strong analytical and decision-making skills to resolve technical challenges.
Qualifications:
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
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.
