Sr. Device Development Engineer (Project Leadership)
Scorpion Therapeutics
Sr. Device Development Engineer — device combination product and/or platform delivery system within a therapeutic area. Responsibilities Lead multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing, Quality) through the device design and development lifecycle. Define detailed product requirements/specifications with commercial, clinical, and strategy collaborators. Define technical specifications/design requirements with engineering partners (manufacturing, verification, packaging). Own and ensure validation of user needs and requirements through design and development. Develop, manage, and communicate development program plans, risks, timelines, and budgets. Integrate device development activities with Chemistry Manufacturing Controls (CMC) and global timing/goals. Support internal and external manufacturing teams with relevant design and process development information transfers. Lead product testing and quality assurance processes for the specific device development. Ensure a compliant Design History File (DHF) meeting 21 CFR Part 3 and 21 CFR 820.30 requirements. Support related clinical/commercial regulatory activities (e.g., IND/IMPD, BLA submission, Clinical Pharmacy Manuals). Understand design inputs/outputs across delivery systems and impacts to end users. Support therapeutic area device leads on strategic product launch and go-to-market plans. Qualifications B.S. in Engineering and 5+ years relevant experience (or equivalent education/experience). Previous product/project management and/or project leadership experience. Skills / Requirements Knowledge of FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30. Experience with design history file management (21 CFR 820.30). Strong project management, interpersonal, analytical, and problem-solving skills. Ability to balance business objectives with technical constraints and work across functional teams. Willingness/ability to travel for partner meetings, audits, and coordination. #J-18808-Ljbffr
$75.3k - $143.9k
...Job Description Regeneron is seeking a Sr. Device Development Engineer to join our project lead team. The Sr. Device Development Engineer will drive the... ...Cardiometabolic, etc.). They will provide comprehensive leadership in engineering product management, regulatory...SeniorRegeneron
East Greenbush, NY2 days ago$88.3k - $143.9k
...Regeneron is seeking a Sr. Device Development Engineer to join our project lead team. The Sr. Device Development Engineer will drive the end-to-end development... ..., etc.). They will provide comprehensive leadership in engineering product management, regulatory compliance...SeniorLocal area$126.3k - $206.1k
...Senior Manager, Medical Device Quality Assurance (QA)... ...team. This expanded leadership role will provide QA oversight... ...Products Sustaining Engineering and Compliance. The... ...quality engineers and project teams during ongoing... ...combination device development and lifecycle process...SeniorContract workMonday to FridayRegeneron Pharmaceuticals
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East Greenbush, NY23 hours ago- ...accountability for client satisfaction, leading in satisfaction survey development, execution and evaluation. Collaborates with client, Sales... ...and resolved and that financial and other issues receive the leadership attention required for appropriate understanding and response...SeniorContract work
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Philips Iberica SAU seeks a Project R&D Engineer, Electromagnetics in Latham, NY. The role entails interpreting engineering requirements to design medical device components, guiding development of test plans for regulatory compliance. Applicants should have a Bachelor’s...3 days per week- ...is seeking an experienced Executive Director for a full-time, permanent role in Albany, NY. The successful candidate will provide leadership, oversee daily operations, manage budgets, and ensure compliance with regulations in a long-term care facility. Candidates must...SeniorPermanent employmentFull time
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...and repair complex electrical and electronic systems, including: PLCs Networks and PC-based logic controls External I/O devices Assist with development of technical documentation, training materials, and troubleshooting guides Document customer support issues and...SeniorHourly payTemporary workWork experience placementFlexible hoursShift workHoneywell
Albany, NY1 day ago- A consulting engineering firm is seeking a Senior Dams Engineer / Project Manager to lead water infrastructure projects in Upstate New York. The ideal candidate... ...culture dedicated to community giving and professional development. #J-18808-Ljbffr GEI Consultants, Inc.Senior
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