Job Description This position is responsible for aspects of the process design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Responsibilities

• Designs fixtures, tools, and machines used to manufacture products.
• Oversees the development of new processes, methods, and production controls.
• Maintains knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes.
• Perform engineering and data analysis for activities such as validations and engineering studies including DOEs and root cause investigations.
• Generate and review process documentation including but not limited to Manufacturing Process Instructions (MPI), Bill of Materials (BOM), and Lot History Records (LHR).
• Generate and execute Engineering Change Orders (ECO).
• Identify and implement process improvements to increase quality, capacity, and efficiency, while reducing waste.
• Monitor process performance using Statistical Process Control (SPC), and other engineering principles.
• Communicate with customers to understand project needs and set expectations for deliverables.
• Reviews production program equipment, hardware, and tooling; make recommendations for repairs or replacement.
• Installs new equipment and ensures that it operates correctly; train others to operate new machinery.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring 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.
• Performs other duties assigned as needed.
• The position does have supervisor responsibilities, is responsible for performance management and the hiring of the employees that are designated under their supervision.

Qualifications

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or related field is required.
• Master's Degree in Mechanical or Biomedical Engineering or related field is preferred.
• Must have one to five (1-5) years' relevant Engineering experience
• Knowledge and experience in catheter design is preferred.
• Experience with CAD software such as AutoCad or Solidworks is preferred.
• Knowledge and experience in development processes and in documentation writing is required.
• Experience with statistical analysis and design of experiments (DOE) preferred.
• Ability to use PC and associated software is required.
• In-depth knowledge of material and metals is preferred.
• Knowledge of Good Manufacturing Process and Good Documentation Practice.

COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies:

• Values: Integrity, Accountability, Teamwork, Innovation
• Excellent verbal and written communication skills
• Ability to work independently
• Ability to manage tight timelines and changing priorities
• Excellent problem -solving techniques
• Proficient with Microsoft office applications
• Skilled at providing technical leadership on cross-functional teams