CIVCO Medical Solutions · 4 days ago
Design Engineering Manager
Coralville, IA
Full-time
Hybrid
Director/Executive
10+ years expCIVCO Medical Solutions is a company focused on innovative medical device solutions. The Design Engineering Manager leads a team in managing the full product lifecycle, ensuring projects meet regulatory, quality, and business objectives while fostering a culture of innovation and continuous improvement.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
Lead, mentor, train, and develop a team of design engineers, engineering technicians, and co-op students to achieve project and career growth objectives
Manage the full product development lifecycle, from concept through design, verification, validation, manufacturing transfer, and sustaining engineering
Provide system-level design leadership, integrating mechanical, electrical, hardware, and software components into cohesive, high-performing medical device solutions
Allocate design engineering resources appropriately across multiple projects to balance priorities, timelines, and business needs
Oversee the engineering lab, ensuring safety, compliance, and effective use of equipment and resources
Foster a culture of innovation and continuous improvement, encouraging new ideas and advanced design practices
Ensure design work complies with regulatory, quality, and safety standards for medical devices
Partner with cross-functional teams (manufacturing, quality, marketing, operations, service, and regulatory) to ensure seamless product development and commercialization
Collaborate with the Service Department to ensure products are designed for serviceability, maintainability, and effective field support throughout their lifecycle
Drive standardization and optimization of design processes, tools, and best practices to improve efficiency and reduce cycle times
Monitor project progress, manage risks, and provide clear reporting to leadership on deliverables and resource needs
Manage department budget, including forecasting, capital planning, and expense control
Align team priorities and engineering initiatives with CIVCO’s strategic objectives to accelerate product development and deliver high-value solutions
Manage relationships with external development partners, including software and PCB design firms, ensuring deliverables meet CIVCO’s quality, regulatory, and business requirements
Qualification
Required
Minimum of a Bachelor's degree (BA/BS) in engineering from a four-year college or university
10 years' experience and/or training in the engineering and development of complex systems (electro-mechanical and software)
5 years of supervisory or project leadership experience desired, preferably in a regulated environment
Demonstrated experience in managing processes related to medical device design and manufacturing
Experience operating in a regulated environment, ideally FDA 21 CFR 820 and ISO 13485
Experience with Microsoft products including but not limited to Word, Excel, Outlook, Teams, Project, etc
Experience with PTC Creo and Windchill products
Experience working in an ERP system
Company
CIVCO Medical Solutions
CIVCO Medical Solutions has over 35 years of experience offering cutting-edge medical technology to a diverse group of medical professionals.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase