AtriCure,
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 Associate 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 ways to achieve the company's goals of producing market‑leading products through positive patient outcomes.
ESSENTIAL FUNCTIONS OF THE POSITION
Team member coordination for projects involving design, manufacturing, and quality resources, both internal and external.
Support of product assembly line technical performance and troubleshooting assembly line issues.
Resolution of non‑conformances, completion of root cause investigations, and CAPAs.
Collaboration with cross‑functional engineering teams (quality, product development, regulatory) to address product line issues.
Communication of manufacturing and process issues to cross‑functional engineering teams and suppliers, both verbally and inrasında documentation.
Review of proposed component tolerances and input to manufacturing capability.
Knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc.
Understanding of GD&T and proper application to achieve desired fits between joining parts.
Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over‑molding, soldering, etc.
Understanding of error proofing, poke‑yoke.
Knowledge of manual and automated assembly systems and technologies.
Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) for medium‑volume manufacturing processes.
Work with outside suppliers to define, document, analyze, and qualify their manufacturing processes.
Identify new vendors, processes, materials, and technologies that can improve product quality and reduce product cost.
Identify and implement manufacturing and Bew-Or product‑related cost reduction opportunities.
Understanding of life‑cycle costs and cost‑benefit analysis.
Application of continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes.
Familiarity with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value‑Stream Mapping, and use of SPC to resolve/improve piston.
Perform process capability assessments and establish methods to control process input.
Working understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t‑tests, acceptance plans).
Operating in a controlled environment with gowning and strict clean‑room procedures.
Definition, communication, and development of fixture concepts using internal and external resources.
Incorporation of typical production capabilities into these concepts.
Work with designers and engineers in development of manufacturing‑related equipment איין fixtures.
Define and track project tooling and equipment schedule and cost.
Responsible for installation of new equipment and setting up preventive maintenance and calibration plans.
Working knowledge of mechanical equipment and gauges such as microscopes, soldering platforms, Ovens/furnces, UV curing stations, Instron, calipers, and other measurement gauges.
Support process qualification strategies and define statistical sample sizes based on variable and attribute data.
Maintain and update process maps and FMEAs.
Write and execute process qualification protocols and reports.
Understanding of Test Method Validation, IQ, OQ, PQ approach per AtriCure Quality System.
Understanding of supply chains, lead times, and raw material availability.
Construction of Bills of Material with proper unit of measure and inventory points.
Knowledge of MRP and other requirement planning systems.
Conduct time studies and analyze cost variances.
EVALUATION OF COMPONENTS FOR CONFORMANCE TO DESIGN INTENT VIA INSPECTION AND FUNCTIONAL EVALUATION.
TRENDS scrap and failure rates, analyze failure modes, and develop plans to address root causes.
Support ongoing manufacturing daily to meet required production goals.
Disposition of non-conforming material.
Document all work in compliance with AtriCure Quality System requirements.
Release of process documents using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems.
Write detailed, easy to understand process instructions ఎంతో test protocols and reports to document qualification activities.
Regular and predictable work performance.
Ability to work under fast‑paced conditions.
Decision‑making and use of good judgment.
Prioritization of various duties and multitasking as required.
Effective teamwork skills.
Additional duties as assigned.
BASIC QUALIFICATIONS
Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
Использованные: 0‑7 years of relevant experience, able to assist the lead engineer for process improvement projects with minimal guidance. Demonstrated mechanical and/or process engineering ability.
Understanding of external standards, design controls, quality controls, manufacturing methods.
Planning and task tracking aligned with project plan and team objectives.
Excellent written and oral communication skills.
Strong influence skills on cross‑functional teams.
Data analysis, problem‑solving, and troubleshooting abilities.
Prioritization of tasks and timely schedule of completion.
PREFERRED QUALIFICATIONS
Medical device industry experience.
Validation experience.
Understanding of industry regulations as it pertains to medical devices.
Graduate degree.
Assembly and machining experience.
Regulatory experience.
Statisticalrijven experience.
Financial analysis experience.
OTHER REQUIREMENTS
Ability to regularly walk, sit, or stand as needed.
Occasional bending and push/pull as needed.
Regular lifting up to 10 pounds; occasionally up to 50 pounds.
Pass pre‑employment drug screen aerosol background check.
BENEFITS & COMPLAINT PROGRAMP 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, 20 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: https://www.atricure.com/careers-atricure/benefits.
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 https://www.e‑verify.gov/.
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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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 Associate 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 ways to achieve the company's goals of producing market‑leading products through positive patient outcomes.
ESSENTIAL FUNCTIONS OF THE POSITION
Team member coordination for projects involving design, manufacturing, and quality resources, both internal and external.
Support of product assembly line technical performance and troubleshooting assembly line issues.
Resolution of non‑conformances, completion of root cause investigations, and CAPAs.
Collaboration with cross‑functional engineering teams (quality, product development, regulatory) to address product line issues.
Communication of manufacturing and process issues to cross‑functional engineering teams and suppliers, both verbally and inrasında documentation.
Review of proposed component tolerances and input to manufacturing capability.
Knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc.
Understanding of GD&T and proper application to achieve desired fits between joining parts.
Review of proposed device assembly requirements and identification of Design for Assembly opportunities.
Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over‑molding, soldering, etc.
Understanding of error proofing, poke‑yoke.
Knowledge of manual and automated assembly systems and technologies.
Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) for medium‑volume manufacturing processes.
Work with outside suppliers to define, document, analyze, and qualify their manufacturing processes.
Identify new vendors, processes, materials, and technologies that can improve product quality and reduce product cost.
Identify and implement manufacturing and Bew-Or product‑related cost reduction opportunities.
Understanding of life‑cycle costs and cost‑benefit analysis.
Application of continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes.
Familiarity with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value‑Stream Mapping, and use of SPC to resolve/improve piston.
Perform process capability assessments and establish methods to control process input.
Working understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t‑tests, acceptance plans).
Operating in a controlled environment with gowning and strict clean‑room procedures.
Definition, communication, and development of fixture concepts using internal and external resources.
Incorporation of typical production capabilities into these concepts.
Work with designers and engineers in development of manufacturing‑related equipment איין fixtures.
Define and track project tooling and equipment schedule and cost.
Responsible for installation of new equipment and setting up preventive maintenance and calibration plans.
Working knowledge of mechanical equipment and gauges such as microscopes, soldering platforms, Ovens/furnces, UV curing stations, Instron, calipers, and other measurement gauges.
Support process qualification strategies and define statistical sample sizes based on variable and attribute data.
Maintain and update process maps and FMEAs.
Write and execute process qualification protocols and reports.
Understanding of Test Method Validation, IQ, OQ, PQ approach per AtriCure Quality System.
Understanding of supply chains, lead times, and raw material availability.
Construction of Bills of Material with proper unit of measure and inventory points.
Knowledge of MRP and other requirement planning systems.
Conduct time studies and analyze cost variances.
EVALUATION OF COMPONENTS FOR CONFORMANCE TO DESIGN INTENT VIA INSPECTION AND FUNCTIONAL EVALUATION.
TRENDS scrap and failure rates, analyze failure modes, and develop plans to address root causes.
Support ongoing manufacturing daily to meet required production goals.
Disposition of non-conforming material.
Document all work in compliance with AtriCure Quality System requirements.
Release of process documents using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems.
Write detailed, easy to understand process instructions ఎంతో test protocols and reports to document qualification activities.
Regular and predictable work performance.
Ability to work under fast‑paced conditions.
Decision‑making and use of good judgment.
Prioritization of various duties and multitasking as required.
Effective teamwork skills.
Additional duties as assigned.
BASIC QUALIFICATIONS
Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
Использованные: 0‑7 years of relevant experience, able to assist the lead engineer for process improvement projects with minimal guidance. Demonstrated mechanical and/or process engineering ability.
Understanding of external standards, design controls, quality controls, manufacturing methods.
Planning and task tracking aligned with project plan and team objectives.
Excellent written and oral communication skills.
Strong influence skills on cross‑functional teams.
Data analysis, problem‑solving, and troubleshooting abilities.
Prioritization of tasks and timely schedule of completion.
PREFERRED QUALIFICATIONS
Medical device industry experience.
Validation experience.
Understanding of industry regulations as it pertains to medical devices.
Graduate degree.
Assembly and machining experience.
Regulatory experience.
Statisticalrijven experience.
Financial analysis experience.
OTHER REQUIREMENTS
Ability to regularly walk, sit, or stand as needed.
Occasional bending and push/pull as needed.
Regular lifting up to 10 pounds; occasionally up to 50 pounds.
Pass pre‑employment drug screen aerosol background check.
BENEFITS & COMPLAINT PROGRAMP 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, 20 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: https://www.atricure.com/careers-atricure/benefits.
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 https://www.e‑verify.gov/.
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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