Medical DeviceCombination Product Engineer

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. Youll 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

• Bachelors 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: $60000 - $75000 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 .

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Required Experience:

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