Manufacturing Engineer II

Duties

Manufacturing Engineering contributes to the following:

• Developing manufacturing processes, production floor layouts, and associated tools.
• Reviewing new designs for manufacturability.
• Designing process improvements to reduce product cost, process cycle time, and improve product quality.

Essential Duties And Responsibilities

• Create documentation to support new and improved manufacturing processes.
• Write and perform process validations.
• Make recommendations for equipment purchases based upon manufacturing needs.
• Perform IQ/OQ/PQ as required on equipment.
• Disposition NCR’s and CAPA’s as assigned.
• Perform experiments including but not limited to DOE’s to characterize and improve processes.
• Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis.
• Cook up with suppliers and external resources needed in developing and implementing new processes.
• Facilitate excellent communications between all team members.
• Communicate business related issues or opportunities to next management level.
• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Ensure compliance with Quality Procedures, Laws and Regulations of the applicable markets.
• Perform other duties assigned as needed.

Skills

• EXPERIENCE: 5-7 years related work experience, preferably in a medical device manufacturing environment preferred.
• Excellent hands-on communication and interpersonal skills.
• Experienced in MS Word, Excel, and Project.
• Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process. Failure Mode and Effects Analysis (FMEA).
• Experience with CAD Software (Solid Works & AutoCAD) preferred.
• Strong Lean Manufacturing background preferred.
• Experience in a Controlled Room environment preferred i.e cleanroom (CER) (must be able to multi-task and operate in a fast-paced environment with minimal training and supervision).
• Strong written, verbal, and interpersonal skills.
• Ability to effectively interact with all levels of employees and management, both in the Manufacturing group and cross-functionally.
• Excellent computer skills ? including advanced working knowledge of Microsoft Office (Word, Excel, Outlook, etc.).
• Understanding of regulations related to FDA, GMP/MDD, and ISO preferred.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
• Works on projects of moderate scope and complexity.
• Identifies possible solutions to a variety of technical problems and takes actions to resolve.
• Applies judgment within defined parameters.
• Receives general guidance may receive more detailed instruction on new projects.

Additional Position Requirements

• Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
• Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
• Work includes potential exposure to chemicals.

Education

• Bachelor degree in Engineering required; Mechanical or Industrial Engineering preferred.