Staff Quality Engineer, Contract Manufactured Product

Staff Quality Engineer, Contract Manufactured Product

AtriCure, Inc. has an opening for the Staff Quality Engineer, Contract Manufactured Product in Mason, OH. The Staff Quality Engineer, Contract Manufactured Product will work closely with Contract Manufacturers, AtriCure engineering, manufacturing, supplier quality, and suppliers to ensure that quality system activities are completed. The role will operate regularly with a cross functional team and shall contribute to the creation of a collaborative work environment. Less than 20% domestic travel and less than 5% international travel anticipated to AtriCure sites and customer sites.

Duties include:

• Provide Quality Engineering support for products generally acquired as finished devices (less some value-added operations); products within this category require routine collaboration with key contract manufacturers, suppliers, and internal functions.
• Oversee and coordinate on-going activities from external (contractor and suppliers) and internal functions (i.e. Engineering, Manufacturing, Quality, Inspection, Document Control) and processes (i.e. Product qualification, process validation, NCRs, FMEA’s, Rework, Deviations, Supplier Change Requests).
• Drive correction and preventive activities including managing NCRs and SCARs, possibly including education of manufacturer in these activities.
• Apply reasoning ability.
• Support and prioritize projects, adapt to shifting priorities, and work with minimal guidance from management assuming ownership of, and drive completion of actions and/or decisions on day-to-day activities.
• Determine appropriate response to novel or controversial problems that may impact the business significantly and present plans to resolve such problems.
• Support Design Assurance (and NPD Teams) new product development at transfer, as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer.
• Contribute to the development and implementation of quality system processes as applicable with the manufacturers.
• Use knowledge of best practices, technical proficiency, and past experiences in quality engineering to mentor junior Quality Engineers.
• Assist with 3rd party, internal, and external FDA and ISO audits as necessary.

Required:

• Bachelor’s degree in Manufacturing Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field (foreign equivalent degree accepted)
• 6 years of progressive, post bachelor’s degree experience as a Quality Engineer or a related role.

• 6 years of experience in each of the following:
  • Sterile packaging of disposable medical devices;
  • EO and Gamma sterilization validation and continuous monitoring;
  • Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc.; and
  • Inspection/testing, TMV/GR&R, and/or data analysis.
• 3 years of experience in each of the following:
  • Using tools in MS Office (i.e. Visio, Power BI, etc.) for communication and analysis;
  • Reading technical specifications, blueprints, and drawings; and
  • In machining, molding, finishing, or assembly in a manufacturing engineering environment.
• 2 years of experience in both of the following:
  • Working with Contract Manufacturers of finished devices; and
  • Working with GD&T.
• Some experience in both of the following:
  • Assessing capability and running hypothesis tests of industrial or manufacturing statistics; and
  • With FDA and ISO 13485 knowledge.

Experience may be gained concurrently.

Ability to pass pre-employment drug screen and background check is required.

#LI-DNI