Manufacturing Engineer II

Industry

Engineering

Advert ID

FOX_BBBH99166

Location

Plymouth

Job Type

Permanent

Hours

Full-Time

Salary Range

Based on Experience

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435

ContactNumber

612-630-1200

Job Description

Manpower Engineering is partnering with a growing medical device company that is now hiring for a Manufacturing Engineer II to join their successful team.



Summary:



The Manufacturing Engineer II will provide manufacturing/process engineering support to new product development projects and production operations. This includes the design, implementation, validation, and/or support of necessary fixtures, tools, processes, and manufacturing documentation required by product development and/or production operations. The Manufacturing Engineer II will also support the procedures/training to implement improved, more cost-effective production processes.



Responsibilities:





* Provide manufacturing technical/engineering support to new product development projects and production.

* Develop equipment qualification and process validation plans, protocols and reports for molding, assembly, and packaging processes.

* Evaluate non-conforming product, perform MRB analysis and disposition of product as required. Support CAPA/NCR/SCAR investigations and reports as needed.

* Design, implement, validate (when required), and/or support assembly tooling/fixturing/processes.

* Create and implement manufacturing procedures, routers, BOM's, and other necessary documentation.

* Support supplier activities from a technical manufacturing perspective for new product development projects and/or production operations.

* Transition development activities into production product, as required.

* Research and investigate new or existing manufacturing assembly technologies which may be applicable (i.e. automation, molding, etc.).

* Interface with Customers to ensure their requirements are met on new product development projects and/or production operations.

* Oversee tooling and automated assembly projects (new and modifications) at suppliers and release test labs

* Develop and track project timelines, cost, and quotes for tooling projects.

* Provide manufacturing technical/engineering support to suppliers for molding and automated assembly.

* Create and revise product and equipment specifications and related documentation.

* Serve as key contact with customers and suppliers, participating in project status meetings (internal/external).

* Collaborate with cross-functional departments and suppliers to create test plans and cost quotes for process updates.

* Manage change controls for continuous improvement/continuous engineering and validation efforts.



Qualifications:





* Bachelor of Science in Mechanical Engineering or equivalent

* 1-4 years of experience in manufacturing engineering within the medical device industry

* Working knowledge of manual/automated assembly preferred

* Experience in GMP or equivalent document intense environment.

* Demonstrated analytical and troubleshooting skills

* Experience designing and implementing assembly tooling/fixturing/processes

* Experience working with suppliers and managing supplier processes

* Experience writing technical contract Statement of Works (SOW) and/or User Requirement Specifications (URS)

* Strong interpersonal and communication skills and ability to effectively with employees and customers at all levels

* Project Management experience

* Experience working closely with both inside and outside customers

* Experience in Process validation