CIVCO is looking for a Design Engineering Manager to lead a team in the development and support of innovative medical device solutions, ensuring projects meet regulatory, quality, and business objectives, while accelerating product development and enhancing operational efficiency.
Requirements
- 10 years’ experience and/or training in the engineering and development of complex systems (electro-mechanical and software).
- 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 PTC Creo and Windchill products.
- Experience with Microsoft products including but not limited to Word, Excel, Outlook, Teams, Project, etc.
- Experience working in an ERP system.
- Must have product and equipment knowledge.
Responsibilities
- 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.
- Ensure design work complies with regulatory, quality, and safety standards for medical devices.
- Drive standardization and optimization of design processes, tools, and best practices to improve efficiency and reduce cycle times.
- Manage relationships with external development partners, including software and PCB design firms, ensuring deliverables meet CIVCO’s quality, regulatory, and business requirements.
- Collaborate with the Service Department to ensure products are designed for serviceability, maintainability, and effective field support throughout their lifecycle.
- Oversee the engineering lab, ensuring safety, compliance, and effective use of equipment and resources.
Other
- Lead, mentor, train, and develop a team of design engineers, engineering technicians, and co-op students to achieve project and career growth objectives.
- Allocate design engineering resources appropriately across multiple projects to balance priorities, timelines, and business needs.
- Foster a culture of innovation and continuous improvement, encouraging new ideas and advanced design practices.
- Partner with cross-functional teams (manufacturing, quality, marketing, operations, service, and regulatory) to ensure seamless product development and commercialization.
- Minimum of a Bachelor’s degree (BA/BS) in engineering from a four-year college or university.
