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Design Engineering Manager

Company: SPR Therapeutics, Inc.
Location: Cleveland
Posted on: August 7, 2022

Job Description:

Unique Cleveland area medical device engineering opportunity! Game changing technology in a rapidly growing neuromodulation medical device company!
SPR Therapeutics, in the Highland Hills/Beachwood area, focuses on developing, manufacturing, and commercializing non-opioid, minimally invasive, neuromodulation treatment, designed to provide sustained pain relief. Summary: Manage the Design Engineering employees and projects including all Design and Sustaining Engineering activities. Utilize management skills to develop and coordinate technical resources in support of product development and sustaining programs within the company. Responsibilities: - Lead Design Engineering resources to sustain existing products and drive product improvements. - Define Design Engineering objectives and manage towards completion of objectives. - Support the Quality Management System (QMS) and related Design Engineering responsibilities, including - Ensure products meet customer, company, and regulatory requirements. - Develop and manage design engineering project budgets and timelines, communicating progress across the organization. - Oversee the maintenance of product Design History Files (DHF) and the creation of the Device Master Record (DMR). - Perform analysis and establish test plans to demonstrate products meet all requirements. - Contribute to New Product Development by managing the Design Engineering resources needed to support the development team. - Provide technical support for the Sales Team, customers, and clinical trial sites as needed. - Support the design transfer to manufacturing. - Contribute to project team activities as assigned. Requirements: - Bachelor's Degree in Engineering discipline (Mechanical, Electrical, Biomedical, or related field). - Minimum 7 years of experience with FDA/GMP regulated medical device development and manufacturing to include a minimum of 2 years of Engineering management experience. - Project management including planning, execution, and meeting time and budget constraints. - Proficient with medical device DHF and DMR files management and documentation requirements. - Experience managing medical device development, design transfer, design for manufacturability (DFM), improving reliability and reducing product cost. - Understanding and experience with FDA regulations and design control requirements.
Why Join Our Team? - Entrepreneurial work environment - A growth oriented and collaborative atmosphere in the medical device industry! - Ability to work with game changing technology. - Competitive compensation and benefits - Employee Wellness Program

Keywords: SPR Therapeutics, Inc., Cleveland , Design Engineering Manager, Engineering , Cleveland, Ohio

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