Manufacturing Engineer II

About the role

The Manufacturing Engineer will provide technical support for all Point of Care meter manufacturing operations under the direction of the Sr Manager and Technical Leads. This role will contribute to the development, design and validation of existing and new equipment or processes.

Responsibilities

• Update/create all forms of manufacturing documentation (AP/TP/OI/OP/BOM/DWG/Artwork) which conform to Quality System Regulations (QSR’s) and ISO Standards.
• Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Master Validation Plans and Continuous Improvement studies/evaluations.
• Provide day to day technical floor support by investigation and resolution of issues that arise during the manufacturing process.
• Aid in the transfer of new products to manufacturing.
• Collaborate with R&D and others to develop production processes, tools, and equipment.
• Train assemblers and operators regarding new processes and assemblies.
• Contribute to continuous improvement programs to reduce cost, cycle times and increase quality.

Requirements

• Proficiency in Microsoft Office & Solidworks
• Experience with Business Operating Systems such as SAP
• B.S. in Mechanical, Electrical, or Industrial Engineering
• Strong communication and interpersonal skills
• Hands On approach to problem solving
• An understanding of FDA QSR’s and ISO regulations

Physical Requirements and Working Conditions

• Being able to sit/stand for extended periods of time
• Being able to traverse the manufacturing floor
• Being able to lift 20 lbs.