Job Description

We are seeking an experienced Systems Engineer to provide technical consulting and systems integration leadership across a range of combination product and drug delivery programs, with a focus on inhalation and nebulizer-based devices.

In this role, you will apply systems engineering best practices to help clients define, design, and verify safe, effective, and compliant products that bridge the interface between drug formulation, device engineering, human factors, and manufacturing. You’ll work collaboratively with cross-functional stakeholders and external partners to bring complex combination products from concept to clinical and commercial readiness.

This position offers the opportunity to shape strategy, guide development, and deliver technical excellence across multiple programs while ensuring alignment with global regulatory standards and patient-centric design principles.

Responsibilities

• Partner with client teams to establish and execute systems engineering strategies for medical device and drug–device combination products.
• Lead or advise on the development of system architectures, user needs, and requirements definitions across mechanical, electrical, and pharmaceutical components.
• Ensure alignment between drug product design, device performance, and clinical use for inhalation and nebulizer-based delivery systems.
• Create and maintain key Design Control documentation including Design History Files (DHF), Risk Management Files, trace matrices, and verification and validation plans.
• Conduct and/or facilitate system risk assessments, use error analyses, and reliability evaluations in accordance with ISO 14971 and 21 CFR Part 820.30.
• Provide technical guidance and mentoring on systems engineering principles, including requirements traceability, configuration management, and design verification strategy.
• Translate user and stakeholder needs into actionable design inputs, ensuring consistency across formulation, device, packaging, and labeling components.
• Support verification and validation testing, including aerosol performance, flow characterization, dose uniformity, and usability testing for inhalation products.
• Conduct gap assessments and provide recommendations for design control, documentation, or risk management improvements.
• Advise clients on applicable standards such as ISO 20072 (Aerosol Drug Delivery Devices), ISO 27427 (Nebulizing Systems), ISO 11608 (Needle-Based Injection Systems), and ISO 13485 (Quality Management Systems).
• Collaborate with third-party design firms, contract manufacturers, and testing labs to ensure program deliverables meet client expectations and regulatory compliance.
• Support regulatory submission activities by providing system-level design descriptions, verification summaries, and risk-based justifications.
• Lead or contribute to continuous improvement initiatives, identifying and implementing best practices across systems engineering, design control, and risk management processes.

Qualifications

• Bachelor or Master’s degree in Mechanical, Biomedical, Chemical, or Systems Engineering, or related technical field.
• Minimum of 5-8 years in medical device and/or combination product development.
• Demonstrated expertise in systems engineering, design controls, and risk management for regulated medical products.
• Proven experience developing or reviewing Design History Files (DHFs) and risk management documentation (RMFs) in accordance with 21 CFR 820.30, 21 CFR Part 4, and ISO 14971.
• Strong working knowledge of inhalation or nebulizer drug delivery systems, including fluid dynamics, aerosol performance, and dose reproducibility.
• Excellent communication, documentation, and client interaction skills.
• Experience working in or with multidisciplinary project teams, including Quality, Regulatory, and Manufacturing functions.
• Experience supporting clients across development, clinical, and commercial stages of combination product programs.
• Familiarity with human factors engineering (HFE) and usability risk assessment methodologies.
• Knowledge of ISO 20072, ISO 27427, ISO 11608, ISO 10993, and EU MDR requirements.
• Experience conducting technical reviews, gap analyses, or due diligence assessments for clients or partner organizations.
• Exposure to electromechanical systems, digital health integrations, or connected inhalation devices.

Location

• Remote

Employee Type

• 1099 or
• W2 Employee

Benefits for W2

• Choice of medical dental and vision plans
• Paid Vacation Time
• Competitive base salary

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled