System Canada Technologies Jobs

Process Engineer Development Improvement

System Canada Technologies

Process Engineer Development Improvement

Posted 5 Days Ago

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In-Office

Boston, MA, USA

Mid level

In-Office

Boston, MA, USA

Mid level

Lead process and manufacturing engineering for Class I/II medical devices: design tooling/equipment, develop and validate processes, scale-up manufacturing, troubleshoot production, manage supplier/contractor transfer, improve QA and technical transfer, drive cost and process optimization, ensure FDA and ISO 13485 cGMP compliance.

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Company Description

SCT resources have a broad range of skills in different technologies. The large skill-set has been made possible by a conscious focus on strengthening our skills base. Every person selected for our team brings something new, something that adds to our offerings. We learn continuously, both on the job and through formal training programs.

Job Description

Company: SystemCanada | www.systemcanada.com

World wide office: Canada - USA - Australia - UK - South Africa - New Zealand - Ireland - Japan

Job Description

Extensive experience in Product Development, Sustaining, Compliance to FDA regulations, Quality, Process and Manufacturing Engineering of medical equipment/devices

Responsible for the design and specification of tooling and equipment, validation & verification, design and development of processes.

Develop best practice in executing process development, scale-up, validation and manufacture troubleshooting.

Develop contractor site of manufacture and packaging supplier. Significantly improved the QA system and technical transfer procedure.

Provide cost improvement project and process optimization,

Prefer certified as Six Sigma Green Belt.

Prefer experience of CAPA investigation.

Experience on of Class I and II medical devices.
Experience on implementing structure following cGMPs for medical devices using ISO 13485.

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