Job Title
Manager, Sustaining Engineering - Medical DeviceRequisition
JR000014149 Manager, Sustaining Engineering - Medical Device (Open)Location
CC-Madison - USA503Additional Locations
Chicago, IL, Madison, WIJob Description
The Manager, Sustaining Engineering guides and supports manufacturing teams across design, sustaining, manufacturing, and quality engineering to meet business objectives for quality, customer satisfaction, cost, and safety. The Manager, Sustaining Engineering identifies, develops, and executes initiatives for continuity of supply, quality improvement, cost reduction, and product safety. As part of the product life cycle management team, the Manager, Sustaining Engineering exhibits agility and resiliency, swiftly transitioning between projects while maintaining engineering excellence. In a cGMP medical device environment, the Manager, Sustaining Engineering prioritizes patient safety and customer satisfaction.
Essential Functions
Leadership of small teams including internal and external resources
Management of projects related to support of current products and/or new product development support
Engagement in cross-functional teams
Process/product changes to resolve field product problems
Process and procedures to comply with regulatory requirements
Process/product changes to resolve internal quality problems
Manufacturing strategies to introduce new products
Resolving system-level design/production problems
Conducting component research/selection and recommendation of suppliers.
Minimum Requirements
Bachelors degree in an engineering discipline or related.
Significant work experience in medical devices may be substituted in lieu of degree.
10+ years of experience in complex medical device design, sustaining or manufacturing engineering role
High degree of interpersonal, influencing skills, negotiation, and team skills.
High degree of supervision/project coordination skills.
Complex problem-solving skills.
Preferences:
In-depth understanding of cGMP requirements, ISO 13485 and other regulatory requirements.
Experience in managing small groups of engineers and small to medium-sized engineering projects including internal and external resources
Strong participation experience in risk analysis and interpretation of risk management files for CAPA
Change request management
System-level troubleshooting (electro-mechanical, electro-pneumatic systems)
Electrical engineering analysis (Analog/Digital)
Root cause analysis
Medical device report generation and review
Cyber-secure networked medical products
Mechanical engineering analysis (fit, tolerance, machinability, finite element)
Design exposure: Pro-E, SolidWorks, EMC compliance
Pneumatic and electromechanical component selection
Statistical methods for failure analysis, reliability, process capability
Development, qualification, maintenance of semi-automated test equipment
Manufacturing process development and qualification
Software structure/logic, PCB design, simulation, component selection
Interpreting product and manufacturing requirements
Environmental testing, reliability evaluation
Analog/Digital simulation, circuit design analysis
Product test requirements, automatic/semi-automatic test equipment systems
Respiratory care device engineering
Organizational Relationship/Scope:
This position routinely interacts with colleagues, including those responsible for but not limited to Product Performance, Device Quality, Post Market Surveillance, Device Development, Materials Management and external resources required to appropriately address all product life cycle issues and new product introduction initiatives. This is an advanced level role requiring in-depth product and therapy understanding across multiple use cases. In-depth understanding of key stakeholder needs is essential, as this role will often interact cross- functionally as a technical resource.
Working Conditions:
Working conditions are those typically found in a final assembly and test environment for medical devices. Workspaces include office environment, sustaining engineering laboratory and device assembly environment. Some travel both domestic and international will be required up to 20%.
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