Praneeth Patlola
This listing was posted on Willhire.
Device Engineer II
Location:
South San Francisco
Description:
<p>Executive Summary:</p><ul><li>The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.</li><li>The candidate has technical expertise in the development and commercialization of drug-device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within Genentech’s device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges.</li><li>The Device Engineer II will be assigned responsibilities to perform tasks and will assist Senior Device Engineers in identifying and defining critical project steps, and develop practical and thorough solutions to problems</li><li>The candidate will work with general direction and may also supervise staff members</li><li>The work is reviewed upon completion.</li></ul><p>Job Responsibilities</p><ul><li>The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.</li><li>This objective will be accomplished by executing activities in the areas of:</li></ul><p>Device Engineering:</p><ul><li>Provide guidance and input regarding product development. This includes creation of technical requirements, test methods/fixtures, Verifying requirements through Design Verification and use of engineering analysis tools</li><li>Create drawings (2D, 3D), perform toleance stackup analysis, use statistics and Design of Experiments to evaluate design performance, perform Root Cause Analysis</li><li>Develop and commercialize devices including interfaces with the primary container.</li><li>Regularly interact with external development partners and components suppliers</li><li>Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.</li><li>Write and execute protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.</li></ul><p>Design Control:</p><ul><li>Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.</li><li>Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.</li><li>Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.</li></ul><p><br />Education and Industry Experience:</p><ul><li>B.S, M.S, Ph.D or advanced degree in Engineering, with preference for Mechanical Engineering, Biomedical Engineering or the equivalent.</li><li>At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.</li><li>Experience in the Pharmaceutical, Biotech or Medical Device industry is preferred, with previous work on development of injection devices.</li></ul><p>Technical Knowledge:</p><ul><li>Application of relevant modeling and design tools, design controls and/or statistical analysis.</li></ul><p>For example:</p><ul><li>Engineering: Electromechanical system design, System engineering.</li><li>Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.</li><li>Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.</li><li>Full data and statistical analysis (JMP, Minitab) and Design of Experiments.</li><li>Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc..</li><li>Six Sigma (Green/Black Belt): DMAIC and DFSS.</li></ul><p>Interpersonal Skills:</p><ul><li>Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.</li><li>Excellent oral and written communication skills are required</li><li>Ability to work with external partners is also highly desirable.</li><li>Highly organized and detail oriented</li></ul><p> </p><p>This is the pay range that Magnit reasonably expects to pay for this position: $48.15/hour-$64.20/hour</p><p>Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)</p><p>Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.</p><p>If you have a disability and need an accommodation in relation to the online application process, please email us at XXXX@magnitglobal.com</p>
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More About this Listing: Device Engineer II
Device Engineer II is a Engineering Engineer Job at Roche and Genentech located in United States. Find other listings like Device Engineer II by searching Oodle for Engineering Engineer Jobs.
Device Engineer II is a Engineering Engineer Job at Roche and Genentech located in United States. Find other listings like Device Engineer II by searching Oodle for Engineering Engineer Jobs.