The Sustaining Engineer at Cook Inc. Spencer will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.
Responsibilities• Interface with Contract Engineers, Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians as necessary to progress projects/tasks• Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals• Analyze risk using CEA and current FMEAs • Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable• Identify user needs and develop into design input requirements • Formulate Verification & Validation Test Plan and collaborating with other COOK departments to execute testing
• Update device and production specifications accordingly • May mentor/coach technicians or other engineering employees (co-ops/interns)
Qualifications• Bachelors Degree in Engineering or Engineering Technology, or experience of such kind and amount as to provide a comparable background• Previous project management experience preferred
• Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving
• Knowledgeable with Windows based software (i.e. Word, Excel, Project, Power Point, Visio)
Skills Required
- Bachelor's degree in Engineering or Engineering Technology, or equivalent experience
- Previous project management experience
- Knowledge of statistical practices (sample sizes, confidence intervals, capability, risk assessment, problem solving)
- Familiarity with Design Control procedures and regulatory standards (21 CFR 820, ISO 13485, ISO 14971) and experience with FMEA
- Proficiency with Windows-based software: Microsoft Word, Excel, Project, PowerPoint, Visio
- Ability to formulate Verification & Validation (V&V) test plans and collaborate to execute testing
What We Do
At Cook, we are building our future on Invention, Connection, People, and Community. As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device. Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
