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Hybrid Sr. Manufacturing Engineer

4 months ago


Marlborough, United States Advantage Technical Full time

Advantage Technical is seeking a Hybrid Senior Manufacturing Engineer

for a global medical device manufacturer in Marlborough, MA.


MUST BE LOCAL CANDIDATES


Hybrid Senior Manufacturing Engineer, External Products

The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12-month plus contract position is part of the Sourced Finished Medical Device team and entails driving improvements suppliers of finished medical devices.

Responsibilities

• Managing projects which include new production equipment, process improvements, cost reduction initiatives, and new product onboarding while supporting the day to day operation success of assigned key suppliers.

• Successfully contributes to both new product development and current product support of suppliers, typically including the following activities: process capability studies, process development, process validation, value improvement projects, protocol / report review and approval, capacity analysis, and process risk reviews.

• Review and manage supplier change requests through the Supplier Change Impact Assessment (SCIA) and Change Notice processes.

• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success.

• Ability to independently designs and coordinate engineering tests and experiments including Design of Experiments.

• Prepares standard reports/documents and presentations to communicate results/recommendations to the technical community or management

• Trains and/or provides work direction to operators/technicians at Supplier Sites (OEM and CM suppliers).

Preferred Qualifications:

• BS in Engineering from ABET accredited institution

• 5 - 8 years of manufacturing experience

• Proven organization and execution skills

• Proven ability to solve technical problems and implement solutions

• Proven leader and team player with the ability to drive tasks / projects to completion

• Willing and able to work with engineers and technical staff from a suppliers at a different site.

• Strong verbal and written communication skills.

• Ability to travel 25% of the time (Including International). Travel typically does not occur over weekends.

Preferred Qualifications:

• Experience in the Medical Device field

• Experience with Contract Manufacturers (CM) and/or Original Equipment Manufacturers (OEM)

• Manufacturing Experience