We are searching for an experienced Combination Products Engineer for one of our top clients. The Combination Products Engineer will lead design control projects and create documents for Design History Files and Risk Management Files to support development and manufacturing of combination products.

Responsibilities

• Support R&D’s efforts by providing engineering expertise and services.
• Manage on market change control projects and new product development projects for combination products.
• Perform Combination Product development activities in compliance with 21 CFR 210, 211, and 820.
• Perform design control activities in accordance with ISO 13485 and FDA 21 CFR 820.30.
• Perform risk management and risk analysis activities in accordance with ISO 14971.
• Design and develop test protocols, experiments, and fixtures.
• Perform experiments, gather and analyze data.
• Develop design verification and validation plans, protocols and reports.
• Project Management.
• Plan, schedule, and complete projects in an aggressive manner consistent with corporate objectives.
• Develop component and system design inputs, specifications, and performance criteria, as needed.
• Ensure project documents, processes and capabilities are complete and current and that they comply with Quality Systems and Regulatory requirements.
• Create technical reports and technical justifications.

Qualifications

• Bachelor's Degree or higher in appropriate Engineering disciplines, e.g. Biomedical, Mechanical; or other related discipline.
• Minimum 2 years of experience in Medical Device, Pharmaceutical, and/or Combination Product Experience.
• Expertise and experience with 21 CFR 210, 211, and 820.
• Experience with requirements creation, management, change control, and traceability.
• Authoring a testing plan, protocol(s), report(s) and conducting investigations during testing.
• Experience with Design Verification and Validation (per ISO 13485 and 21 CFR 820 regulations), including simulated use testing.
• Experience with Risk Management – top down and bottom up analysis.
• Experience with the creation of DFMEA, Use FMEA, PFMEA, and Hazard Analysis documents.
• Experience with creating and managing Design History Files in accordance with ISO 13485 and FDA 21 CFR 820.30
• Labeling regulations/label development.
• Managing scope and depth of requirements/ fit for purpose for co-development (non-organic).
• Leading meetings and providing status updates to management.
• FDA and EU regulations and standards affecting medical devices and combination products.
  

Location

• Boston, MA or
• Remote for the right candidate

Employment Type

• Consulting

Compensation and Benefits

• $60 to $100/hr. depending on experience.
• Choice of medical, dental, and vision plans
• Paid vacation time
• 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 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