Packaging EngineerMason, OH

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 Packaging Engineer is an individual contributor in a fast-paced, high-performing team, providing production support, partnering with design to define packaging requirements, and implementing packaging processes and equipment. This role identifies and advances packaging technologies to meet internal and external customer needs, drives process improvements to strengthen functional deliverables, and supports investigations to resolve packaging-related issues and complaints. The engineer also interfaces with packaging production equipment to ensure successful packaging implementation and reliable production operations.

ESSENTIAL FUNCTIONS OF THE POSITION:

Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include:

• Review and implementation of proposed device packaging requirements and identification of opportunities. Understanding of error proofing, poke-yoke.
• Provide ongoing technical support to manufacturing to ensure compliance and security of supply.
• Drives projects with packaging development focus towards innovation, sustainability and usability that align with team objectives.
• Work and communicate effectively in a cross-functional environment, including Marketing, Quality, Manufacturing, PD and Regulatory departments.
• Identify critical packaging functions and determine the manufacturing techniques that will provide the optimal outcome; make cost/benefit trade-offs.
• Lead sterile barrier sealing process studies and validations of sealing equipment.
• Apply efficiency strategies such as Lean, Six Sigma, 5S, and value stream mapping.
• Review of proposed component tolerances and input to manufacturing capability. Has knowledge of tolerance capabilities related to various packaging designs.

TOOLING AND EQUIPMENT:

• Assist in developing packaging concepts using internal and external resources.
• Understanding of ergonomics as related to repetitive stress injuries.
• Define and track project tooling and equipment schedule and cost.

VERIFICATION AND VALIDATION:

• Perform process qualifications (IQ/OQ/PQ) in alignment with the AtriCure quality system.
• Interpret Process FMEAs and use the output to improve manufacturing processes.

MANUFACTURING LOGISTICS:

• Understand supply chains, lead times, and raw material availability.
• Working knowledge of MRP and other requirement planning systems.
• Understanding of standard costing and variances. Able to conduct time studies and analyze cost variances.

TROUBLESHOOTING AND ROOT CAUSE ANALYSIS:

• Analyze product returns and determine the root cause of customer complaints.
• Evaluate packaging conformance; trend scrap and failure rates; analyze failure modes; and develop plans to address root cause issues.
• Support daily manufacturing to meet required production goals.
• Disposition of non-conforming materials.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Demonstrate reliability and professionalism through consistent attendance and follow-through.
• Manage multiple priorities in a fast-paced environment, adjusting plans as needed to meet deadlines.
• Collaborate effectively across functions and communicate status, risks, and decisions in a timely, professional manner.
• Additional duties as assigned.

BASIC QUALIFICATIONS:

• Knowledge in the areas of flexible packaging concepts and technologies are valued (i.e. barrier films, bags, printing, primary and secondary packaging, etc.).
• Bachelor's degree required or demonstrated equivalent combination of education, training and experience.
• 2+ years of experience in a comparable position.
• Inspection/testing experience.
• Computer/data entry skills.
• Verbal & written/report writing skills.
• Ability to read technical specifications.
• Ability to read blueprints, drawings, and specifications.

PREFERRED QUALIFICATIONS:

• Experience operating in a medical device regulated quality system.
• Statistical use experience.
• Knowledge and understanding of packaging test methods/standards (ISO) and related test and sealing equipment pertaining to Medical Device Packaging.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed.
• Availability to travel up to 10%.
• Ability to lift 50lbs.
• Ability to occasionally bend and push/pull as needed.
• Ability to pass pre-employment drug screen and background check.

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AtriCure has a variety of benefits available for US based employees and their families. Examples include 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, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website:

AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

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