Manager, Sustaining Engineering - Medical Device

Job TitleManager, Sustaining Engineering - Medical Device

Requisition

JR000014149 Manager, Sustaining Engineering - Medical Device (Open)

Location

CC-Madison - USA503

Additional Locations

Chicago, IL, Madison, WI

Job 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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JR000014149