Senior Manufacturing Engineer

Looking for a hands-on, motivated, and tactical Manufacturing Engineer to join the team at leading Medical Device Company. This is a fantastic 6 month contract-to-hire opportunity for an engineer who is looking to thrive and excel within a company.

This strategic Manufacturing Engineer will be involved with the final assembly of both catheters and stents. My client is looking to fill this role as soon as possible, so I encourage you to apply as soon as possible if interested!

Responsibilities include:

· Developing and maintaining documentation necessary to ensure the consistent manufacture of products (processes, drawings, and shop floor paperwork).

· Working with Process Development engineers to ensure design for manufacturing elements are incorporated into PDP activities.

· Identifying, justifying, and implementing multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.

· Designing and evaluating new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.

· Identifying and recommending manufacturing technologies to strategically develop business objectives and potential opportunities.

· Complying with applicable FDA regulations

Candidates must meet the following qualifications:

· 4 to 8 years of relevant experience in the Medical Device Industry

· Stent and catheter final assembly experience

· Experience with design and process FMECA, Process Validation and variability reduction applications.

· Experience with medical device based products and processing and technologies.

· Implementation and support of Lean Manufacturing, Demand Flow, Total Quality tools.

· Application of statistical and analytical methods such as SPC, SQC, and DOE.

· Process background (development, capability, optimization, validation) within a regulated industry.

· Development of manufacturing documentation (MP, IP, BOM)

· Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design)

· Participation on project teams tasked with new process/product development and the successful transfer into manufacturing.

· Manufacturing continuous improvement support.

· Test protocol generation, execution, and reporting.

· BS or MS degree (Engineering, Manufacturing, or other technical field)
To find out more about Real please visit www.realstaffing.com