Sustaining / Process Engineer Medical Device

• →Primary focus: Support the manufacturing line and advance the processes/device to support scale up.

• →Create and document new manufacturing processes as necessary for production at significantly higher volumes and validate as appropriate

• →Support ongoing manufacturing activities including dealing with production equipment, non-conformances, facilities and other line related issues. This includes quickly SOLVING issues with laminators, laser welders, hot boxes, etc. in order to keep the line moving.

• →Spending significant time on the manufacturing line alongside the assemblers to improve processes and increase quality. You are the primary interface between engineering and production.

• →Responsible for ongoing process monitoring

• →Assist development of assembly and test fixturing with a focus on quality and volume

• →Write protocols & test reports related to validation activities

• →Generate/support Quality documentation to represent Manufacturing: NCR’s, CAPA’s, deviations, etc.

• →Collaborate with existing suppliers to improve manufacturability and decrease cost

• →Qualify components from new suppliers to improve supply chain flexibility

• Demonstrated ability to collaborate effectively, especially with a team of diverse assemblers

• Solid history of experience in a medical device manufacturing environment (5+ years preferred)

• Hands-on mechanical aptitude with direct experience working on production equipment is required

• Solid experience with either lamination or laser welding is required

• Proficiency in SolidWorks is helpful but not required

• Experience editing Manufacturing Procedures (MPs), Lot History Records (LHRs), Bills of Materials (BOMs), etc. is required

• Comfort using inspection and test equipment (vision systems, tensile testing) is a plus

• Experience working within and maintaining compliance in a highly regulated environment

• Demonstrated ability to work independently in a fast-paced, small company environment

• Flexibility and willingness to take on a variety of roles

• Strong verbal and written communication skills

Principals only please

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