We are seeking a highly skilled Combination Products Systems Engineer with direct experience in on-body injector (OBI) devices to support one of our key clients in the pharmaceutical/biotechnology sector. In this consulting role, you will be responsible for leading and supporting systems engineering activities across the product development lifecycle of combination products, ensuring compliance with relevant regulations and standards.
Responsibilities
- Serve as a technical expert in the design and development of on-body injector combination products, including drug-device integration.
- Lead and execute systems engineering tasks, including requirements gathering, functional decomposition, interface definition, risk analysis, and verification planning.
- Collaborate with cross-functional teams, including quality, regulatory, and clinical, to ensure the device meets intended use and performance requirements.
- Author and review design control documentation, including system requirements, design specifications, risk management files, and traceability matrices.
- Conduct design reviews, root cause analysis, and support failure investigations for development and post-market issues.
- Ensure compliance with applicable regulatory standards and guidance, including FDA 21 CFR Part 4, ISO 13485, ISO 14971, IEC 62366, ISO 11608, and FDA Guidance for Combination Products.
- Provide technical input for design verification and validation (V&V) strategies and test protocols.
- Act as a liaison between device development teams and pharmaceutical/CMC stakeholders to ensure system integration and combination product performance.
Qualifications
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Systems Engineering, or a related field.
- 5+ years of experience in medical device or combination product development, with at least 2 years focused on on-body injectors or wearable drug delivery systems.
- Strong understanding of design controls and systems engineering methodologies.
- Experience with combination product regulatory requirements (FDA, EMA) and associated guidance documents.
- Proven experience in risk management (ISO 14971) and requirements management tools (e.g., DOORS, Jama, Polarion).
- Familiarity with drug delivery devices, electromechanical systems, and disposable/biologic-device interfaces.
- Excellent communication and documentation skills; ability to interact with internal and external stakeholders at all levels.
- Prior experience with commercialized on-body injector platforms (e.g., wearable patch pumps, electromechanical OBIs).
- Knowledge of Human Factors Engineering (HFE) and usability testing.
- Experience working in an Agile or hybrid product development environment.
Location
Employee Type
Compensation
- Hourly rate: $50-$125/hour, depending on experience and qualifications
Benefits (W2 engagement)
- Choice of medical and dental plans
- Paid time off
- 401(k)
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 onboard 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.
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