Intellectt Inc

Role : staff Engineer, Verification and Validation. The Staff Engineer, R&D Verification and Validation, is the technical lead in the design verification or design validation of electromechanical medical devices developed by embecta.. Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering or related field.. Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies.. Established expertise in leading engineering analysis to predict behavior of proposed designs with analysis tools based on analytical or computational methods (e.g. Minitab, Matlab, etc

staff engineer

Hi, Hope you are doing well, This is Bhanu from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the below job description and if you are interested, please forward your resume to bhanuprakash@intellectt.com Role: staff Engineer, Verification and Validation Location: Andover MA - Hybrid (1-2 days Remote) Duration: Full time Vacation: PTO, Floating Holidays and Paid Company Holidays Opportunities: Yes - Multiple areas that this individual can advance into. Benefits <ul><li>Medical & Health Insurance</li><li>21 Days of PTO</li><li>3 Paid Floating Holidays</li><li>9 Paid Company Holidays</li></ul> Description The Staff Engineer, R&D Verification and Validation, is the technical lead in the design verification or design validation of electromechanical medical devices developed by embecta. Reporting to the Associate Director, R&D Verification and Validation, the successful candidate brings prior electromechanical medical device design, development and qualification experience and a passion for delivering innovative, cost effective and reliable medical device solutions to their customers. Required Skills <ul><li>IEC 60601: Product Safety Standards for Medical Device REQUIRED - 5 years working at a company in the Medical Device Industry</li><li>Experience and understands statistical analysis and engineering strategies. Is able to understand how to complete the technical responsibilities, understands why they exist and the purpose and can master the planning and preparation stages of executing the goal.</li><li>Is well versed enough to be a mentor and teach others.</li><li>REQUIRED - Has experience with Class 2 and Class 3 Devices (Any candidates submitted can NOT have only Class 1, must have class 2 and 3, if they have both classes AND class 1, that works</li><li>REQUIRED - Has completed at least one project of Design Validation vs Verification for Med Device Development and dissemination test validation cycle.</li><li>If a candidate has a series of contract work in their work history, this worker will need to provide solid examples of how they fulfilled their project from start to finish. A huge plus would be experience with fusion pumps!</li><li>10+ years of experience </li></ul> Minimum Qualifications <ul><li>Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering or related field.</li><li>10+ years of professional experience leading or supporting product development projects, including electrical and mechanical systems.</li><li>5+ years of experience with leading or executing Design Verification of disposable electromechanical medical devices.</li><li>Practical experience with various elements of the New Product Development (NPD) process; including design lifecycle phases and product design qualification in order to make regulatory submissions (US -FDA or other geographic region agencies)</li><li>Experience with defining and executing testing regimen to demonstrate compliance with IEC 60601 for mechanical safety/essential performance.</li><li>Demonstrated experience with developing and executing product reliability test plans for both durable and disposable medical devices.</li><li>Experience with implementing product changes through a structured, phase-gated product development process that compiles with FDA regulations for Design Control.</li><li>Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies .</li><li>Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions.</li></ul> Desired Qualifications <ul><li>Graduate degree (MS or PhD) in Engineering or related field</li><li>10+ years of post-educational experience in Medical Device Design highly desired</li><li>Experience as lead in the development of medical disposable devices highly desired</li><li>Experience with software or firmware development compliant with IEC 62304 highly desired</li><li>Six Sigma certification training / experience</li><li>Pharmaceutical Infusion pump development experience </li><li>Expertise in common risk management techniques highly desired</li></ul> Knowledge, Skills And Abilities <ul><li>Established expertise in leading engineering analysis to predict behavior of proposed designs with analysis tools based on analytical or computational methods (e.g. Minitab, Matlab, etc.).</li><li>Demonstrated deep understanding of establishing project and product requirements.</li><li>Regulatory standards (21CFR 820, IEC 60601, ISO 14971, ISO 13485), and system level V&V planning and execution.</li><li>Knowledge of Design for Six Sigma (DFSS) methodology.</li><li>Excellent verbal and writing skills.</li></ul>

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