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Manager, Engineering
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Pager New York, United StatesPager is a virtual care collaboration platform that provides access to whole-person healthcare in a trusted, convenient, connected care experience, like having a "doctor in the family." Pager helps people make better healthcare decisions by enabling better access and reducing cos ...
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Engineering Manager
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Graduate Roosevelt Island New York, United StatesCompensation Type: Yearly Highgate Hotels: · Highgate is a premier real estate investment and hospitality management company widely recognized as an innovator in the industry. Highgate is the dominant player in U.S. gateway markets including New York, Boston, Miami, San Francisco ...
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Value Engineering Project Manager
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Oscar Health New York, United StatesHi, we're Oscar. We're hiring two Associate Product Managers, Process Engineering to join our Product team. · Oscar is the first health insurance company built around a full stack technology platform and a focus on serving our members. We started Oscar in 2012 to create the kind ...
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Hardware Engineering Manager
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Senior Engineering Manager
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Fusion Dynamics Lakes of the North, United StatesHENSOLDT is a leading company in the European defense industry with a global reach. The company, based in Taufkirchen near Munich, develops sensor solutions for defense and security applications. · As a technology leader, HENSOLDT drives the development of defense electronics and ...
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Omega Dynamics East York, United StatesAbout the Company · Welcome to our subsidiary of Wiebe Holding GmbH & Co. KG, the leading company in the construction industry. We take pride in delivering high-quality construction projects and are looking for dedicated employees to join our team. If you have a passion for const ...
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Engineering Manager
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Engineering Manager
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Engineering Manager
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Engineering Manager
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Engineering Manager
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Engineering Manager
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Engineering Manager
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Engineering Manager
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Engineering Manager
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SkyBridge Luxury & Associates New York, United StatesSkyBridge Luxury & Associates is proud to announce our partnership with an extraordinary hotel located in the heart of New York City. We are currently seeking an experienced Engineering Manager to join their esteemed team. In this role, you will be responsible for overseeing all ...
Engineering Manager - New York, United States - RegenTX, LLC
Description
The Engineering manager will lead a Product Development team comprising of project engineers and product managers. The Engineering Manager will be responsible for the planning, managing, and supporting all product development projects within their team. This encompasses both sustaining and new product development initiatives.Duties & Responsibilities:
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Develop and execute product development and product management strategies in alignment with business objectives.
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Oversee product development projects for compliance with quality and regulatory requirements.
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Communicate product strategies, updates, and performance metrics to leadership.
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Develop and manage budgets for product development.
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Conduct market research to identify product opportunities and market trends.
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Identify and mitigate potential risks associated with product development.
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Author, review, and approve product development and product management documents (procedures, validations, marketing materials, etc.).
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Support the development of validation, verification, and qualification protocols for compliance with regulatory requirements and project objectives.
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Review and approve validation, verification, and qualification plans, protocols, execution data, and summary assessments for completeness and compliance with regulatory requirements.
Review and approve project plans to ensure alignment with the business, marketing, sales, and user needs.
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Provide oversight, support, and approval of project timelines for accuracy and accountability.
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Oversee product design development for effective solutions and scalable manufacturing processes.
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Oversee and support technology transfer of new and licensed technologies.
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Oversee and support the development of new product financials (COGS, Gross Margin, etc.).
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Conduct group trainings for direct reports to provide education on regulatory requirements, design controls, validations, product development and product management processes.
Provide technical expertise and guidance on varied product development aspects including product design, project management, manufacturing, and marketing.
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Participate in the development and review of risk management documents such as failure modes and effects analysis (FMEA).
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Collaborate with the Research Department to ensure product development objectives are met.
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Collaborate with the QA & RA Departments to develop quality supplier agreements, labeling, product claims, 510k submissions, regulatory strategies, and sales & marketing materials.
Assist with investigation of product quality events and corrective and preventive (CAPA) actions.
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Support regulatory and reimbursement submissions for products.
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Patent new technologies and processes.
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Conduct performance reviews, monitor annuals goals and establish performance improvement plans as needed.
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Manage work schedules and timesheets.
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Maintain a working knowledge of ASTM, AAMI, ISO, and other necessary validations or testing guidances required for product development projects.
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other regulatory requirements, if applicable.
Starting job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments.
Perform other related duties as assigned.
Skills & Abilities:
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Strong verbal and written communication skills, including presentation skills.
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Strong technical writing ability.
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Ability to manage a cross functional team.
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Knowledge of cleanroom manufacturing environments and validation procedures.
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Strong analytical and creative thinking skills.
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Ability to work in a fast-paced environment.
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Ability to secure and maintain a favorable background investigation and clearance.
Education & Experience:
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Bachelor's or master's degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required.
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8 + years of product development experience required.
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3+ years of leadership and management experience preferred.
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Experience in mechanical design and 3D modeling required.
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Experience in manufacturing process design required.
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Experience with 21 CFR Design Controls required.
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Proficiency in project management required.
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