Job Title

Requisition

Location

Additional Locations

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.

• 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.

• 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

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 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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