Ventura Solutions partners with pharmaceutical, biotech, and medical device companies to support device development from early design through commercialization. We're always interested in connecting with experienced Combination Product and Medical Device Engineers to join our consulting team. Applications are reviewed as client projects become available, and our recruiting team will reach out when there's a match for your background.

Responsibilities

• Support design and development of drug delivery devices and combination products, such as autoinjectors, prefilled syringes, pens, inhalers, and on-body injectors
• Develop and maintain design control deliverables, including design inputs, requirements, traceability, verification and validation plans, protocols, and reports
• Lead or contribute to risk management activities under ISO 14971, including hazard analyses, FMEAs, and risk management reports
• Plan and execute design verification testing and test method validation
• Contribute to design history files and technical documentation for regulatory submissions
• Work with cross-functional teams across R&D, Quality, Regulatory, Human Factors, Manufacturing, and external device partners
• Support design transfer, process validation, and manufacturing readiness

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Chemical, or a related engineering discipline
• 5+ years of engineering experience in medical devices, combination products, or drug delivery
• Hands-on experience with design controls under 21 CFR 820 / QMSR and ISO 13485
• Working knowledge of risk management per ISO 14971
• Strong technical writing skills and comfort producing DHF-quality documentation
• Ability to work independently and adapt quickly to new client teams and systems
• Experience with 21 CFR Part 4 and combination product development is a plus
• Familiarity with ISO 11608, ISO 11040, or other device-specific standards is a plus
• Experience supporting regulatory submissions (510(k), NDA/BLA device sections, or EU MDR) is a plus
• Prior consulting or contract experience is a plus
• Experience with requirements management tools such as Jama, DOORS, or Polarion is a plus

Location

• Remote, hybrid, or on-site depending on the client project.
• Some projects may require travel.

Employee Type

• W2 consultant, 1099, or Corp-to-Corp, depending on the project.
• W2 Starting at $50/hr, with a range of $50–$90/hr depending on experience and level.
• 1099 and C2C rates are negotiated separately.

Benefits for W2

• Medical and dental insurance
• Paid time off
• 401(k) after 90 days

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