Summary

The Design Engineering Manager leads a team of engineers, engineering technicians, and co-op students in the development and support of innovative medical device solutions. This role is responsible for managing the full product lifecycle, from concept and design through validation, manufacturing transfer, and sustaining engineering. The manager ensures appropriate allocation of design resources across projects, oversees the operation of the engineering lab, and fosters a culture of innovation to drive new ideas and continuous improvement in product design. By providing technical leadership and fostering collaboration with cross-functional teams, the Design Engineering Manager ensures projects meet regulatory, quality, and business objectives. In addition to driving engineering excellence, this role develops talent, optimizes design processes, and aligns team priorities with CIVCO’s strategic goals of accelerating product development, enhancing operational efficiency, and delivering high-value solutions to customers.

Essential Duties and Responsibilities include the following. (Other duties may be assigned.)

• 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.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have product and equipment knowledge.

Education and/or Experience

• 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.

Travel

• There is an expectation that this position may travel up to 10% of the time.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear.
• The employee is frequently required to use hands to finger, handle, or feel.
• The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.

Work Environment

• Onsite presence is preferred daily; however, a hybrid schedule (three days onsite, two days remote) may be available once the employee has completed training and demonstrated the ability to successfully perform the essential duties and responsibilities of the position.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is frequently exposed to moving mechanical parts.
• The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock.
• The noise level in the work environment is usually moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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