Principal Manufacturing Engineer

 

AtriCure, Inc. has an opening for the Principal Manufacturing Engineer in Mason, OH.

Duties include:

 

Implement lean manufacturing principles to improve efficiency and reduce waste Conduct Design for Manufacturability (DFM) and Design for Assembly (DFA) analyses to ensure product designs are optimized for production; Develop and maintain process documentation, including work instructions, process flow diagrams, and control plans; Coordinate with cross-functional teams, including R&D, Quality, and Supply Chain, to support new product introductions and process improvements; Develop detailed project plans, including timelines, resource allocation, and risk management strategies Prepare and present project status reports to senior management; Manage multiple projects simultaneously, ensuring timely completion within budget; Lead continuous improvement initiatives to enhance product quality and manufacturing efficiency; Conduct training sessions and workshops to disseminate best practices and new technologies within the team; Provide technical guidance and mentorship to junior engineers and technicians; Stay current with industry trends and advancements in manufacturing technologies; Develop, specify, procure, and validate manufacturing equipment and tooling; Characterize the process parameters and output using design of experiments (DOE); Develop and implement preventive maintenance programs for critical equipment; Troubleshoot and resolve equipment-related issues to minimize downtime; Design and develop custom jigs, fixtures, and tooling to improve manufacturing processes; Implement automation solutions to enhance production efficiency and consistency; Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) and internal quality systems; Conduct root cause analysis and implement corrective actions for process-related issues; Collaborate with the Quality Assurance team to develop and execute validation protocols; Perform Failure Mode and Effects Analysis (FMEA) to identify and mitigate potential risks in manufacturing processes; and 10% domestic travel and 5% international travel anticipated to AtriCure sites and supplier sites.

Required:

Bachelor’s degree inIndustrial Engineering, Mechanical Engineering, Production Engineering or related field (foreign equivalent degree accepted) and 10 years of progressive, post degree experience as a Manufacturing Engineer or closely related role OR Master’s degree inIndustrial Engineering, Mechanical Engineering, Production Engineering or related field (foreign equivalent degree accepted) and 8 years of progressive, post degree experience as a Manufacturing Engineer or closely related role 5 years of experience in each of the following: Manufacturing in the medical device industry; Development of semi-automatic, vision systems, or manual assembly equipment for medical device manufacturing; Implementing Design for Manufacturability (DFM) and Design for Assembly (DFA) strategies to optimize component designs for efficient and cost-effective manufacturing processes; Design of experiments (DOE) or process characterization; Application of advanced statistical tools or techniques (such as process capability analysis and statistical process control) for the process development or validation activities; Fixturing and gages development; Developing manufacturing plans or project plans and independently managing time to lead projects; Good manufacturing practices (GMPs) and Good documentation practices (GDPs) in technical writing; and Applying Geometric Dimensioning & Tolerancing (GD&T). 3 years of experience in each of the following: Lean manufacturing principles; Technical writing in the medical device industry; and Mentoring junior engineers in process development and validation activities.

 

2 years of experience leading project review presentations to executive management team

 

Experience may be gained concurrently. Ability to pass pre-employment drug screen and background check is required.

 

 

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