RHODE ISLAND

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Sustaining Engineering Manager

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This company is dedicated to working collaboratively with their customers, taking their projects from rapid prototype into high colume production. Thier unparalleled technical expertise, proven experience and partnership with thier customers have allowed them to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Their primary capabilities include: nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. 

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Education and Experience:

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• Bachelor's Degree in a technical discipline.

• Ten years experience in a technical role in a regulated ISO compliant industry and/or training and equivalnet combination of education and experience.

• Prior medical device contract manufacturing and technical personnel management experience preferred.

• Proven problem-solving skills.

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Skills and Responsibility:

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• In depth knowledge of medical device Design Control standards and regulatory requirements.

• Good interpersonal relationship and people skills. Strong team player.

• Excellent verbal and written communication skills.

• Ability to apply that knowledge to the interpretation of customer requirements.

• Strong written skills to produce reports, business correspondence, and procedures.

• Strong analytical skills to analyze and present technical information and respond to questions from groups of managers, customers, vendors, and others.

• Strong understanding of statistics including DOE, ANOVA, regression, T/F testing. Ability to train others on implantation of DMAIC system and statistical analysis.

• Ability to manage skilled workforce and foster teamwork and innovation.

• Manage the Company’s production products. Implement continuous improvement, SPC, and lean programs. Support and monitor ongoing production maintaining and improving yields and OEE.

• Support NCM, CAPA, Internal Audit, Customer Complaint Systems, and comply with documented procedures.

• Coordinate and implementation validation procedures for IQ of equipment and final product validations.

• Manage process change system working to notify and qualify changes with customers and perform risk assessments related to changes.

• Manage a team of engineers, technicians, and others responsible for developing robust and stable processes that maximize yields, efficiencies and process capabilities. Set priorities and timeline for development projects.

• Responsible for training engineers, technicians, and operators as well as provide mentorship and career development support to engineers and technicians. Interface and collaborate with Sustaining and Quality Engineering groups.

• Interact with customers, vendors, and other employees concerning technical problems and assure that effective corrective action is implemented.

• Design, document, and implement methods for process control and process improvement.

• Collaborate with identifying, investigating, and developing new technologies for textile processing. Develop strategic processing goals and objectives and integrate processes into Lean value streams.

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 Please email a copy of your resume to blair.carter@searchrsa.com