Manufacturing Engineer II

• ◆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
• ◆Coordinate with suppliers and external resources needed in developing and implementing new processes
• ◆Work closely with R&D and Manufacturing to capture and interpret design intent in order to refine and improve processes
• ◆Facilitate excellent communications between all team members
• ◆Responsible for communicating business related issues or opportunities to next management level
• ◆For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• ◆Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• ◆Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
• ◆Performs other duties assigned as needed

• ✓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
• ✓Work reviewed for sound reasoning and accuracy

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.

Bachelor degree required – some majors that would fit the role are below with the priority also in order:

• ✓Biomedical Engineer
• ✓Chemical Engineer
• ✓Mechanical Engineer