Job Description

We are seeking a Junior Engineer / Engineer II to apply engineering and technical skills to support the development, improvement, and maintenance of medical devices and combination products. In this role, you will contribute to the creation and upkeep of Design History File (DHF) documentation and support compliance with 21 CFR 820.30 Design Controls and ISO 14971 Risk Management.

You will collaborate with cross-functional partners to research requirements, support design verification and validation activities, contribute to human factors assessments, and help maintain DHF and risk management deliverables that ensure the safety and efficacy of new and existing products.

Responsibilities

As a Junior Engineer / Engineer II, you will support new product development and the remediation/maintenance of existing product lines by assisting with the creation, management, and analysis of DHF documentation, product risk management files, and associated engineering design records. Depending on the project, you will:

• Participate in early use-case discussions and focus groups to identify unmet needs for design concept development.
• Work with marketing and cross-functional teams to help translate unmet needs into clear User Needs.
• Support the development and maintenance of Design History Files (DHF) and Risk Management Files.
• Research clinical use cases, industry standards, and regulatory requirements to support product development and regulatory submissions.
• Assist in analyzing product complaints, standards, and clinical data to generate robust design inputs and user needs.
• Partner with functions such as Manufacturing, Clinical/Safety, Human Factors, Quality, Regulatory, and Design Engineering to support risk assessments.
• Contribute to FMEA development and risk mitigation activities under appropriate guidance.
• Support inspection readiness activities as needed for medical devices and combination products.
• Assist with gap assessments against industry regulations, standards, and internal procedures.
• Extract and summarize technical information from internal studies for use in regulatory submissions or inspections.
• Support design verification and validation activities (test protocol development, execution, and documentation).

Qualifications

• Bachelor's degree in engineering with 3+ years of experience in developing medical devices, drug delivery devices, and/or combination products.
• An Engineering degree in Biomedical, Mechanical, Chemical, or Industrial engineering is a great fit, but other engineering degrees will be considered.
• Experience creating and maintaining Design History Files (DHF) and ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management.
• Medical Device and/or Combination Product Experience.
• Exposure to prefilled syringes, autoinjectors, or other drug-delivery devices.
• Basic understanding of engineering principles, system design, traceability, and risk management.
• Experienced with performing risk assessments using a variety of tools.
• Experience leading other engineering disciplines to execute and able to support product development technical challenges.
• Experience with design verification and validation.
• Experience with change control and design transfer.
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues.
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgment.

Preferred, but not required, Qualifications

• Experience with statistical analysis, DOE, or Minitab.
• Familiarity with EU MDR requirements.
• Experience with human factors engineering or usability activities.
  
• Knowledge of consensus standards related to combination products (e.g., biocompatibility, particulate, sterility).
• Experience working with external development partners.
• Familiarity with ISO 11608 series or ISO 24971 guidance.

Location

• Illinois is preferred but open to remote (US)

Employee Type

• W2 Employee

Benefits

• 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