Medical Device/Combination Product Engineer

2 weeks ago

Vernon Hills, IL, United States Ventura Solutions Inc. Full time

We are seeking passionate and driven Medical Device/Combination Product Engineers to join our medical device consulting team. This is an ideal opportunity for recent graduates or those with limited experience who are excited to apply their academic knowledge in real-world product development.

If you have a strong interest in medical devices, pharmaceuticals, and combination products, and are eager to gain hands-on experience in product development, design controls, and risk management - we want to meet you

As a Medical Device/Combination Product Engineer, you will support the development and maintenance of medical devices and combination products by assisting with technical documentation, testing, and cross-functional collaboration. You'll contribute to the creation of Design History Files (DHF), risk management files, and other engineering documentation in accordance with industry regulations and standards such as FDA 21 CFR 820 and ISO 14971.

Responsibilities

  • Assist in developing and maintaining Design History Files (DHF) and Risk Management Files for medical devices and combination products
  • Support product development activities, including gathering user needs, design inputs, and testing requirements
  • Participate in risk assessment activities, such as creating or supporting FMEAs
  • Help prepare and review technical documentation for design verification and validation
  • Research applicable regulations, standards, and guidance documents to support compliance efforts
  • Work closely with cross-functional teams, including Quality, Regulatory, Manufacturing, Human Factors, and Clinical
  • Contribute to design control activities and help ensure traceability from requirements through testing
  • Support documentation for inspections and regulatory submissions
Qualifications
  • Bachelor's degree in Biomedical Engineering or related engineering discipline (e.g., Mechanical, Chemical, Electrical)
  • Strong academic foundation in engineering principles and a desire to apply them in a regulated industry
  • Understanding of or exposure to design control, risk management, and product development lifecycle through coursework, internships, or academic projects
  • Strong written and verbal communication skills
  • Detail-oriented with good documentation and organizational skills
  • Team-oriented with a willingness to learn and grow in a fast-paced environment
Preferred (Not Required) Experience
  • Internship, co-op, or project work related to medical devices, drug delivery, or combination products
  • Familiarity with standards like ISO 13485, ISO 14971, or FDA design control regulations
  • Exposure to tools such as FMEA, DHF documentation, or verification test planning
  • Experience with engineering software (CAD, Minitab, MATLAB, etc.)
Location
  • Northwest Chicago Suburbs or remote for the right candidate
Employee Type
  • W2 Employee
Compensation and Benefits
  • Salary: $60,000 - $75,000 annually, depending on experience
  • 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

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