Advantage Technical has partnered with an innovative medical device company improving the lives of people with diabetes and other conditions.
The candidate will work on the addition of new manufacturing lines and equipment. The candidate will work with various team members within the company to ensure the successful validation and performance of new manufacturing equipment and processes.
The candidate will support in building documentation such as validations, work instructions, SOPs, and tool files.
Responsibilities: • Support equipment validation activities at the company manufacturing facilities • Support responsibility for project phases from installation, training, qualification, implementation into manufacturing, and support. • Generate validation/qualification (IQ, OQ, TMV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports • Support in developing documentation for new equipment including technical drawings, user manuals and operation manuals. • In addition to standard engineering, this person will help with the hands-on assembly of the equipment, and should be comfortable with physical aspects of the job (lifting, etc.). • The team has several technicians primarily responsible for assembly. • Experience with SolidWorks is a must.
Skills required • Excellent knowledge of SolidWorks and drafting • Excellent in Microsoft Word • Moderate Microsoft Excel • Comfortable working around mechanical equipment both Semi and fully automated • Ability to lift up to 20lbs occasionally
Education and Experience • Preferred BS. in Mechanical Engineering or similar • 2+ years experience as an Engineer; preferably in a manufacturing environment