Our client is seeking a Development Engineer primarily responsible for ensuring medical devices and combination products meet their intended function. This includes the development of data through engineering studies that informs new product development as well as test reports that support product submissions. The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis. This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.

Responsibilities

• Partner with Systems engineers in defining product requirements such that they are verifiable.
• Development of test fixtures, test methods, and performance of Test Method Validation activities.
• Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies.
• Ensure integrity and compliance of data according to Standard Operating Procedures.
• Develop Design Verification Plans including test strategy.
• Utilize technical writing and statistical data analysis skills to write protocols and reports.
• As necessary, conduct root cause analysis and derive recommendations based on analysis of data.
• Translate inspections and tests methods into component and product specifications.

Qualifications

• B.S. in Engineering discipline and 5 to 15 years of related experience, preferably in Mechanical/Chemical/Biomedical Engineering.
• Familiarity with ISO standard test methods and related test instrumentation preferred. Excellent analytical and communication skills are required. Ability to work and solve problems in a team environment. Technical writing skills are required for protocol and report writing.
• Strong statistical analysis skills with Minitab, preferred.
• Experience writing Design Verification and Validation Plans, Protocols, and Reports.
• Experience performing test method validations, TMV, Preferred.
• Combination product experience, preferred but not required.
• Green Belt and/or Black Belt Certification a plus.
• Manufacturing operation experience a plus.

Location

• Northern New Jersey, within the Greater NYC Metro Area

Employment Type

• W2 employee

Benefits

• 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.

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