Sustaining Engineering Manager

The Sustaining Engineering Manager leads the Engineering Lab team in the development maintenance and continuous improvement of Cadwells cutting-edge medical devices. This leadership role oversees the technical team that provides long-term engineering sustaining support of released products as well as supporting prototyping and testing efforts for products in development. As a team leader they are responsible for the development and growth of skilled technicians and engineers along with the identification planning and maintenance of the techniques processes systems and tools they use every day to optimize team quality efficiency and consistency.

Job Duties and Responsibilities:

• Lab Team Ownership: Oversees and leads the Engineering Laboratory team in supporting both new development and post-release sustaining of Cadwells medical devices; includes failure analysis design verification testing component management production/procurement support design improvements and releasing new and updated engineering design
• Team Leadership & Growth: Provides mentorship and guidance to Laboratory Technicians and Engineers assisting in their technical development and strategically growing and diversifying skills and team composition to best support Cadwells success
• Manage and Monitor Resources: Oversees and actively manages Engineering Laboratory resources to ensure they are efficiently applied to both projects and smaller supporting activities; continuously evaluates team outputs and workload to proactively identify and communicate resource needs and schedule impacts adjusting plans and priorities as needed
• Reactive Work Management: Ensures timely resolution of engineering support escalations from other departments as well as externally sourced escalations from Cadwells vendors
• Sustaining Change Planning and Oversight: Leads engineering change control efforts for released designs chairing change control activities and crossfunctionally coordinating with Production Procurement and Manufacturing Engineering as necessary to ensure success
• Laboratory Systems Ownership: Provides leadership on and direction for the systems (standards processes checklists and tools) used by the Engineering Laboratory team; continuously monitors and manages the performance of the Engineering Laboratory team and systems against set goals
• Technical Expertise: Maintains strong technical skillset to evaluate guide and continually improve the teams produced work; ensures that work quality meets Cadwell design standards and industry best practices
• Inter-team Collaboration: Partners with other departments such as Procurement Manufacturing Service Software & Hardware Engineering Regulatory Affairs Quality Assurance and Supplier Quality Engineering to ensure they are supported as needed
• Regulatory and Process Compliance: Ensure the teams processes trainings and outputs align with applicable regulations (FDA 21 CFR Part 820 ISO 13485 etc.) and Cadwell processes; supports internal and external audits from FDA and Notified Bodies
• Perform other duties as assigned

Qualifications:

Knowledge Skills and Abilities:

• Comprehensive knowledge of engineering team leadership staff development and development of engineering procedures checklists and work instructions
• Comprehensive knowledge of PCB design from concept through manufacturing transfer and post-release support; includes Design-For-Manufacturability and Test (DFM/DFT) analysis
• Thorough knowledge of electrical engineering principles including failure analysis reliability engineering component selection and risk-based decision making.
• Thorough knowledge of common embedded electronic circuits such as DC-DC converters embedded microcontrollers memory interfaces sensors and other technologies
• Thorough knowledge of regulatory compliance and Quality Management Systems (QMS) required for Medical Device
• Thorough knowledge of the entire hardware development life cycle including development testing change control deployment to production and maintenance
• Ability to plan organize and exercise sound judgment; communicates plans and schedules well motivate and lead employees and collaborate with other teams
• Ability to clearly assess articulate and manage risk with a sense of urgency to meet product requirements on schedule and on budget. Must be able to see the big picture prepare contingency plans and ensure execution of plans through effective organizational awareness

Education and Experience:

• B.S. in Electrical Engineering or equivalent worked experience
• Typically has greater than ten (10) years of relevant professional or technical engineering management experience of increasing responsibility and difficulty of assignment
• Experience designing regulated equipment. Ideally this experience is in a medical or similar safety-conscious highly regulated industry

Physical Requirements And Working Conditions:

• Positions working with Cadwell equipment generally may require some reaching bending stooping squatting crawling kneeling pushing pulling lifting and carrying up to 50 pounds finger dexterity repetitive motions standing walking sitting hearing visual acuity color vision and 2-way written/verbal communication. More specific details may be provided as needed or requested.
• Extensive use of a computer will be required.
• Travel may be required; must be able to obtain necessary travel documents.
• Work hours outside normal business hours may be required at times to meet business needs.

Cadwell Industries Inc. is an Equal Opportunity Employer and affirms the right of every individual to participate in all aspects of employment without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position please contact our Human Resources department at.