Senior Process Engineer

AtriCure • Mason, OH

6d • Onsite

About The Position

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: The Senior Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes. He/she contributes in a creative and collaborative way to achieve the company’s goals of producing market leading products through positive patient outcomes.

Requirements

• Bachelor’s degree in engineering (mechanical, industrial, or related field) required or demonstrated equivalent combination of education, training, and experience.
• 7+ years of relevant experience.
• Demonstrated Mechanical and/or Process Engineering ability.
• Solid understanding of external standards, design controls, quality controls, manufacturing methods.
• Demonstrates the ability to plan and track tasks to align with project plan and team objectives.
• Demonstrates excellent written and oral communication skills.
• Demonstrates excellent ability to work on and influence cross functional teams.
• Demonstrated ability with data analysis, problem-solving, and troubleshooting.
• Capable of prioritizing tasks and provide a timely schedule of completion.
• Ability to travel 5%.
• Ability to regularly walk, sit, or stand as required.
• Ability to occasionally bend and push/pull.
• Ability to pass pre-employment drug screen and background check.

Nice To Haves

• Medical device industry experience.
• Demonstrated validation experience.
• Solid understanding of Industry regulations as it pertains to medical devices.
• Lean Six Sigma certification – green or black belt.

Responsibilities

• Ownership of product assembly line technical performance.
• Support production with troubleshooting assembly line issues, resolution of non-conformances, completion of root cause investigations, and CAPA’s.
• Collaborate with cross-functional engineering team (quality, product development, regulatory) to address product line issues.
• Responsible for communication of manufacturing and process issues to cross functional engineering team and suppliers, both verbally and in written documentation.
• Review of proposed component tolerances and input to manufacturing capability.
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
• Identify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost.
• Identify and implement manufacturing and product-related cost reduction opportunities.
• Apply continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes.
• Perform process capability assessments and establish methods to control process output.
• Able to define, communicate, and develop fixture concepts using internal and external resources.
• Work with designers and engineers in the design and development of manufacturing-related equipment and fixtures.
• Define and track project tooling and equipment schedule and cost.
• Responsible for proper installation of new equipment and setting up proper preventive maintenance and calibration plans.
• Responsible for developing detailed process qualification strategies.
• Able to define statistical sample sizes as related to variable and attribute data based on established company and industry standards.
• Responsible for maintaining and updating Process maps and FMEAs.
• Responsible for writing and executing process qualification protocols and reports.
• Understand supply chains, lead times, and raw material availability.
• Able to construct Bills of Material, with proper unit of measure and inventory points.
• Able to conduct time studies and analyze cost variances.
• Responsible for evaluating components for conformance to design intent via inspection and functional evaluation.
• Responsible for trending scrap and failure rates, analyzing failure modes, and developing plans to address root cause issues.
• Responsible for supporting ongoing manufacturing on a daily basis to allow them to meet required production goals.
• Responsible for disposition of non-conforming material.
• Properly document all work in compliance with AtriCure Quality System requirements.
• Responsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems.
• Write detailed, easy to understand process instructions.
• Write detailed test protocols and reports to document qualification activities.
• Regular and predictable worksite attendance.
• Ability to work under fast-paced conditions.
• Ability to make decisions and use good judgement.
• Ability to prioritize various duties and multitask as required.
• Ability to successfully work with others.
• Additional duties as assigned.

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• Full access to our on-site fitness center and cafeteria (for Corporate-based employees)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior