Associate Engineer, Manufacturing Engineering - Apidel Technologies

Description/Comment:

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This function will be directlysupporting the EUMDR project on Site.

Requirements:

Education and Special TrainingRequired: Bachelors Degree in Engineering or relevant field of studyQualifications and Work Experience Required

1-3 years experience in aproduction/manufacturing environment.

Demonstrated computer skillsusing Microsoft Office applications (Word, Excel, PowerPoint, Project, etc),and experienced work in a Quality Management System and UDI/MDD/MDR/UKCARegulatory Compliance project experience is preferred.

Demonstrated interpersonal,communication and presentation skills. Must be comfortable presenting at teamlevel meetings and lead meetings as necessary.

Demonstrate strong teamworkand time management skills as well as be able to operate in a fast-pacedenvironment.

Ability to perform in and bechallenged by a multi-disciplinary team-based environment, which places a highdegree of emphasis on accountability for quality/GMP/GDP compliance.

Provide technical support forquality control, process improvement, equipment qualifications, and processvalidations.

Operate within s qualitymanagement system (QMS) to produce and/or review documentation such as,inspection guide sheets, product drawings, dynamic control plans (DCPs), andstandard operating procedures (SOPs)        StartTime:            8:00 AM

Hours:   8:00am to 5:00pm

Additional Job Details:

Periodically workindependently with vendors.

2D drawing & GD&Tknowledge or experience.

Create and manage EngineeringChange Requests as well as product impact assessments.

Manage Engineering ChangeNotices for process changes from creation to final approval

Demonstrate a generalunderstanding of Product Part Approval Process (PPAP)

Demonstrate a generalunderstanding of First Article Inspection (FAI) process

Periodically lead projects andprocesses; work with cross-functional teams to get these projects completed.Ability to multi-task between different projects and changes.

Investigate Quality issues forroot cause and recommend/implement corrective actions.

Ability to oversee teammembers workload and provide support when issues arise.

Work to support team membersas both mentor/mentee when necessary.