The Clinical Quality Manager will support the Clinical Affairs Organization in ensuring the quality and compliance of studies conducted within the clinical portfolio. This role will be responsible for leading and proactively driving clinical quality behaviors, accountability, and cross-functional collaboration (e.g. Clinical Programs, Scientific Affairs, AtriCure Quality, Regulatory Affairs, Medical Directors, Study Teams, Investigational Trial Sites, and external vendors) with respect to clinical quality assurance activities. The Clinical Quality Manager will also drive continuous improvement in adherence to agency regulations and standards, GCP, global industry guidelines, and AtriCure policies, procedures and processes for the conduct of clinical studies.
ESSENTIAL FUNCTIONS OF THE POSITION:
Maintain and monitor AtriCure clinical processes and procedures for compliance with applicable regulations and industry best practices, driving clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.g. Standard Operating Procedures (SOPs), Work Instructions (WI) and Templates).
Lead implementation of Quality processes including audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant AtriCure policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
Support and/or represents the company in clinical audits, coordinating responses with Regulatory Affairs, AtriCure Quality, Scientific Affairs, legal, and vendors as applicable.
Identifies non-conformance with requirements, providing suitable recommendations and facilitating ongoing quality improvements using optimal methodologies while maintaining compliance with applicable study protocols, and global regulatory requirements as applicable.
Lead and contribute to the development and maintenance of Clinical Quality metrics for input into process improvement initiatives and/or presentation to study management and leadership teams.
Lead the development and delivery of clinical quality compliance related training to internal functional groups, providing guidance and ensuring study teams are following targeted SOPs/WIs during a study.
Assist in development of GCP audit strategies across clinical programs and/or studies.
Plans, develops and manages audits of clinical vendors, clinical sites, and/or internal clinical processes, and manages pre/post inspection follow-up activities (e.g. reports, corrective actions) as applicable.
Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulations, including quality control checks of the eTMF to ensure it is inspection ready.
Assure appropriate oversight of Clinical Software Validation and Supplier/Vendor Qualification/Management and Approved Supplier Lists in accordance with SOPs as applicable.
Leads and/or supports audits, risk assessments and inspections of clinical study vendors. Work with vendors and support personnel in eliminating issues via root cause analysis techniques to continuously review and improve existing processes.
Leads, develops and/or implements inspection readiness programs (e.g. BIMO) and associated activities working closely with cross-functional team members to drive audit/inspection readiness activities and clinical responses, driving process improvements as needed.
Responsible for the development and operational implementation of quality assurance initiatives, process improvements, and sound quality principles and practices.
Leads and/or supports harmonization of processes and procedures across the Clinical, Regulatory, Scientific and Medical Affairs Organization as needed, including AtriCure Registry Studies.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
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
BASIC QUALIFICATIONS:
Bachelor's degree with relevant medical, scientific/clinical experience.
Minimum 5 years of experience working in medical device (preferred), pharma, biotech clinical quality assurance/operations roles.
Direct experience with health authority inspections such as US FDA BIMO inspections (Sponsors, CROs and/or Clinical Investigator sites), BSI inspections etc.
Experience preparing investigational sites for inspection by regulatory agencies.
Experience in auditing clinical vendors, CROs and internal clinical programs.
Exceptional written and verbal communication and influencing skills, with the ability to communicate effectively at all levels of the organization including with external regulatory agencies.
Strong people leadership and talent development skills.
Demonstrated strategic thinking and leadership skills.
Independently motivated, detail oriented, strong analytical and problem-solving skills, with a focus on risk management and continuous improvement.
In depth knowledge of guidelines and FDA/ISO regulations for pre- and post-market clinical trials.
Previous experience of CTMS, eTMF and EDC systems.
Skilled at working effectively in a collaborative team environment.
Proficient in Microsoft Office skills, including Excel, Word, and Power Point.
Ability to exercise judgment and determine appropriate action.
Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment, and manage deadlines.
PREFERRED QUALIFICATIONS:
Master's degree with 3 years relevant medical, scientific/clinical experience in a GCP practice area; Clinical Quality Assurance or similar role preferred.
Global Clinical Quality experience (e.g. APAC, EU, UK, etc.)
Expert CAPA knowledge and experience
Previous experience working as a Clinical Quality Manager within a cardiology therapeutic area
Direct management of clinical quality personnel (Quality specialists), remote and onsite, providing work direction, guidance and mentoring
OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
25% travel possibility
Ability to pass pre-employment drug screen and background check
#LI-KN1
$92k-117k yearly est. 10d ago
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Shipping/Receiving Clerk I
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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/Title: Shipping and Receiving Clerk I Department: Operations Reports To: Distribution Manager AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. POSITION SUMMARY: This position will be responsible for all receipts to and shipments from the company. This individual will be required to receive material within the system making sure all required documentation is present and the counts are accurate. This person will also be required to pack and ship material to vendors, or finished product to the sterilizer for processing through Work Orders. The Shipping and Receiving Clerk will also be required to accurately pick, pack and ship finished goods to customers and Sales Reps. while following all inventory processes and procedures with an emphasis on safety, and accuracy. In addition, this person will be required to participate in all physical inventory activities. This person will also be required to operate a pallet jack and forklift. ESSENTIAL FUNCTIONS OF THE POSITION: Demonstrates a good level of understanding of the inventory system in Great Plains (GP) Demonstrates the ability to research inaccuracies within GP Demonstrates the ability to work independently and achieve a standard level of work volume and accuracy Demonstrates the ability to complete all required documentation for shipments Perform all receiving and shipping activities Accurately pick, pack, and ship product and materials to vendors, customers, and or sales representatives Responsible for the integrity of system inventory data for their assigned areas of responsibility Identify and communicate material issues and shortages that may disrupt production activities Trusted to monitor the expedite report to identify and route parts accordingly Responsible for the organization and cleanliness of their assigned inventory areas Responsible to maintain records as required by the quality system ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable worksite attendance Ability to work under fast-paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: High School diploma or demonstrated equivalent combination of education, training and experience equivalent Minimum of 3 years of work experience in related field Computer/data entry skills Good organizational and verbal communication skills Detail oriented and able to multi-task Ensures professional interactions with customers and employees Seeks out opportunities to learn new skills and acquire information PREFERRED QUALIFICATIONS: FedEx and/or UPS shipping experience Previous Inventory or Warehouse experience Knowledge of Microsoft Office Suite Knowledge of cGMP and ISO standards OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 25 lbs. Ability to pass pre-employment drug screen and background check #LI-AM1
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: *************************************************** 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).
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 cryo ICE cryo SPHERE 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 Education Specialist will assist in developing and maintaining training materials aligned with business objectives, using instructional design methodologies and digital learning tools. This role combines clinical knowledge, instructional design, and strong writing skills to educate healthcare providers, internal teams, and external stakeholders. The specialist will also assist with medical writing and editing and provide support while working closely with members of the Professional Education team and other AtriCure departments. ESSENTIAL FUNCTIONS OF THE POSITION: Work directly with the lead Instructional Designer to assist to develop innovative learning and support materials including eLearning, webinars, and assessments Work with Learning Management Systems administrators to create custom dashboards for various departments within the organization Incorporate learning technologies within courses/curricula, including digital media, social learning, gaming, visual learnings, as appropriate Work with subject matter experts and key stakeholders to develop learning objectives for training programs Ensure that presented material (IFUs, eLearning, presentations, customer tools, etc.) is consistent with current product iteration, procedure and technique, and software version Ensure training and certification material is consistent with sales and marketing messaging and branding Develop and manage material for online customer training, internal eLearning, field-team training, presentations, and customer learning/support materials which facilitate the achievement of AtriCure objectives Assist with slide creation for HCP courses and provide medical writing and editing. Manage delivery of all content through AtriCure's content approval process and ensure it is posted in proper locations ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance 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 BASIC QUALIFICATIONS: Bachelor's degree Excellent organization and communication skills Intellectually curious Familiarity with content delivery methodologies including eLearning, mobile learning, web, and audio/visual presentations Proficiency in MS Office, especially PowerPoint and/or other tools to develop training content to be delivered via a learning management system. Willingness to travel up to 25% OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to pass pre-employment drug screen and background check #LI-KN1
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: *************************************************** 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).
$47k-63k yearly est. 12d ago
Principal Clinical Quality Specialist
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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 Principal Clinical Quality Specialist will support the Clinical Affairs Organization in ensuring the quality and compliance of studies conducted within the clinical portfolio. This role will be responsible for leading and proactively driving clinical quality behaviors, accountability, and cross-functional collaboration (e.g. Clinical Programs, Scientific Affairs, AtriCure Quality, Regulatory Affairs, Medical Directors, Study Teams, Investigational Trial Sites, and external vendors) with respect to clinical quality assurance activities. The Principal Clinical Quality Specialist will also drive continuous improvement in adherence to agency regulations and standards, GCP, global industry guidelines, and AtriCure policies, procedures and processes for the conduct of clinical studies. ESSENTIAL FUNCTIONS OF THE POSITION: Maintain and monitor AtriCure clinical processes and procedures for compliance with applicable regulations and industry best practices, driving clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.g. Standard Operating Procedures (SOPs), Work Instructions (WI) and Templates). Support implementation of Quality processes including audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant AtriCure policies, procedures, regional and local regulatory requirements, and global guidelines and standards. Support and/or represents the company in clinical audits, coordinating responses with Regulatory Affairs, AtriCure Quality, Scientific Affairs, legal, and vendors as applicable. Identifies non-conformance with requirements, providing suitable recommendations and facilitating ongoing quality improvements using optimal methodologies while maintaining compliance with applicable study protocols, and global regulatory requirements as applicable. Lead and contribute to the development and maintenance of Clinical Quality metrics for input into process improvement initiatives and/or presentation to study management and leadership teams. Lead the development and delivery of clinical quality compliance related training to internal functional groups, providing guidance and ensuring study teams are following targeted SOPs/WIs during a study. Assist in development of GCP audit strategies across clinical programs and/or studies. Assist in planning, developing and managing audits of clinical vendors, clinical sites, and/or internal clinical processes, and manages pre/post inspection follow-up activities (e.g. reports, corrective actions) as applicable. Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulations, including quality control checks of the eTMF to ensure it is inspection ready. Assure appropriate oversight of Clinical Software Validation and Supplier/Vendor Qualification/Management and Approved Supplier Lists in accordance with SOPs as applicable. Supports audits, risk assessments and inspections of clinical study vendors. Work with vendors and support personnel in eliminating issues via root cause analysis techniques to continuously review and improve existing processes. Leads, develops and/or implements inspection readiness programs (e.g. BIMO) and associated activities working closely with cross-functional team members to drive audit/inspection readiness activities and clinical responses, driving process improvements as needed. Responsible for the development and operational implementation of quality assurance initiatives, process improvements, and sound quality principles and practices. Supports harmonization of processes and procedures across the Clinical, Regulatory, Scientific and Medical Affairs Organization as needed, including AtriCure Registry Studies. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance 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 BASIC QUALIFICATIONS: Bachelor's degree with relevant medical, scientific/clinical experience. Minimum 7 years of experience working in medical device (preferred), pharma, biotech clinical quality assurance/operations roles. Direct experience with health authority inspections such as US FDA BIMO inspections (Sponsors, CROs and/or Clinical Investigator sites), BSI inspections etc. Experience preparing investigational sites for inspection by regulatory agencies. Experience in auditing clinical vendors, CROs and internal clinical programs. Exceptional written and verbal communication and influencing skills, with the ability to communicate effectively at all levels of the organization including with external regulatory agencies. Strong people leadership and talent development skills. Demonstrated strategic thinking and leadership skills. Independently motivated, detail oriented, strong analytical and problem-solving skills, with a focus on risk management and continuous improvement. In depth knowledge of guidelines and FDA/ISO regulations for pre- and post-market clinical trials. Previous experience of CTMS, eTMF and EDC systems. Skilled at working effective in a collaborative team environment. Proficient in Microsoft Office skills, including Excel, Word, and Power Point. Ability to exercise judgment and determine appropriate action. Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment, and manage deadlines. PREFERRED QUALIFICATIONS: Master's degree with 5 years relevant medical, scientific/clinical experience in a GCP practice area; Clinical Quality Assurance or similar role preferred. Global Clinical Quality experience (e.g. APAC, EU, UK, etc.) Expert CAPA knowledge and experience Previous experience working as a Clinical Quality Manager within a cardiology therapeutic area OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds 25% travel possibility Ability to pass pre-employment drug screen and background check #LI-KN1
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: *************************************************** 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).
We anticipate the application window for this opening will close on - 23 Jan 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Bring your sales talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career in sales that changes lives.
To grow sales and market share for an assigned territory by promoting, selling and servicing Vascular products. Build business by aggressively developing new accounts and driving therapy adoption of DCB, Atherectomy, and the full PV product portfolio across the continuum of care for PAD. Practice good, ethical territory management in terms of organization, planning, administration and expense planning and control. Train medical staff on products and procedures. Meet expectations as defined by Sales Management.
**POSITION RESPONSIBILITIES:**
Planning/Results Orientation
+ Consistently meet and exceed AOP, sales budget and account development targets (QoQand YoY)
+ Develops and executesaccurateand on-going sales plan to achieve sales objectives
+ Maintains and consistently grows market share across all product lines
+ Identifyopportunities within current and new customer base; develop and implement sales strategies to drive business growth and account penetration
+ Leverage the full product portfolio to maximize sales and share performance
+ Monitors key market trends and competitive market information and informs sales management of relevant data/changes
+ Ensure maximum coverage of all accounts within territory geographic areas tomaintainoptimumlevel of exposure and effective time management
+ Effectively manage expenses to drive business growth and adhere to company policies and procedures
+ Adheres to financial, regulatory, quality compliance standards and requirements
Influence and Selling
+ Identify,establishand maintain productive working relationships with key decision makers, customers and their staff, administrators, etc. that drive business and therapy adoption
+ Drives value in accounts through disciplined pricing resulting in strong ASPs
+ Effectively uses contracts to drive high compliance and pullthrough ofall products.
+ Leverage APV, Corporate Accounts, and CVG partnerships to capitalize on partnership and contracting opportunities
+ Probes to understand and confirm customer needs, effectivelyengagesand overcomes customer objections
+ Effectively plans and manages referral marketing resources to drive expected outcomes
+ Effectively builds consensus, gainsappropriatecommitmentsand closes business
+ Plan and implement effective sales/product presentations to customers
+ Maintain and expand existing business; develop new business opportunities
+ Represent company at industry conferences and maximize potential by targeting specific customers to gain sales leads and pursue opportunities to promote the company's product range
+ Develop and implement strategies to counter competitors
Customer Service
+ Educates customers to ensure that products and features are understood and used effectively
+ Respond to customer requests and resolve complaints in a prompt and effective manner
+ Effectively plans cases with physicians, manages theirexpectationsand improves outcomes when supporting cases
+ Engages physicians in clinical conversations about advantages of the Peripheral Vascular products
+ Conducts all business with customers in a manner that adheres to ethics & compliance guidelines and FDA requirements
Communication
+ Work with internal functions (marketing, customer service, finance, etc.) to meet targets (ie. Inventory management audits, customer service protocols,etc.)
+ Communicate market intelligence/competitor activity promptly, including potential sales leads, informationregardingproduct pricing or account activity to District Sales Manager and otherappropriate companypersonnel
+ Contribute to the development ofa strong teameffort
Self-Development and Product Knowledge
+ Develop andmaintaincomprehensive technical/clinical knowledge and capabilities
+ Recognize and understand competitive products, features, strengths in relation to the company's products
+ Participate in product and skills development programs, managing own self development
+ Maintain strong ongoing knowledge of the reimbursement landscape
**BASIC QUALIFICATIONS:**
_IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME_
+ Bachelor's degree, AND
+ 5+ years of B2B sales or healthcare sales experience
OR
+ 5 years total sales experience with a minimum of 2 years of Medtronic sales experience(Bachelor's DegreeRequired)
**DESIRED/PREFERRED QUALIFICATIONS** **(optional)** **:**
+ Sales experience in medical devices, capital equipment sales, surgical sales & in-hospital pharmaceuticals
+ Degree in biological science or business preferred
+ Must be able to meet hospital vendor credentialing requirements
+ Business planning skills
+ Presentation skills
+ Demonstrated ability to work independently & drive results
+ Must be willing to travel, some overnight potentiallyrequired
+ Knowledge & experience in operating room, hospital & physician office protocol/conduct
+ Ability to teach & educate medical personnel, peers & technical support personnel
+ Demonstrated ability to grasp use of technology & applications (ie. iPad, SalesForces.com); PC literate
+ Top 10% past performance; President's Club winner
**PHYSICAL JOB REQUIREMENTS:**
+ Lifting/carrying 20 pounds
+ Sit/stand/walk 6-8 hours a day
+ Operate moving vehicle
**Environmental Exposures**
+ Infectious disease; radiation; blood borne pathogens
+ Must be able to wear all required personal protective equipment (PPE)
+ Ability to work in Cath Labs
+ Ability to travel extensively by carand plane
+ Ability to conduct company business outside of typical Monday through Friday, 8:00 am to 5:00 pm; work schedule preferred
+ Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be consideredas part of your application
**Work and Travel Requirements**
+ Ability to travel extensively by carand plane
+ Ability to conduct company business outside of typical Monday through Friday, 8:00 am to 5:00 pm; work schedule preferred
+ Must have a valid driver's license and active vehicle insurance policy. In addition, your driving record will be reviewed and will be considered as part of your application
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (********************************************************** .
In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards on page 6 here.
The provided base salary range is used nationally. The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):80000
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans (**************************************************************************************************************
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (************************* .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (*************************************************************************************************************************************** a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will...
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (*********************************** .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email *******************
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$43k-55k yearly est. 13d ago
Legal Coordinator I
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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: Charged with delivering legal solutions to all departments and entities within this global company, the AtriCure legal group is busy and dynamic, handling myriad tasks including but not limited to transactional work, litigation and strategic development. The Legal Coordinator will help to support the day-to-day functions of AtriCure's Legal Affairs team. ESSENTIAL FUNCTIONS OF THE POSITION: Use the contract lifecycle management system to administer all contract intake requests to ensure timely and accurate processing Manage the signature process for all contracts and other documents for the Legal Affairs team Handle the filing of all executed contracts within the CLM tool, including entry of all contract metadata Assist members of the organization with locating executed contracts within the CLM Run screenings within third party KYC screening platform, including monitoring of ongoing screenings Coordinate with legal vendors and AtriCure Finance to facilitate the vendor setup process for all new vendors Coordinate with third party translation provider to assist attorneys and paralegals with all translation needs Assist with user administration for CLM tool Monitor the shared legal email inbox, resolving and escalating emails as necessary Carry out various other legal operations and support tasks as needed ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance 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 BASIC QUALIFICATIONS: Bachelor's degree from an accredited four-year college or university and one to two years related experience and/or training required; or equivalent combination of education and experience Excellent skills in the following areas: follow-up, organization, critical thinking, flexibility, and internal processes Must possess the ability to navigate within a corporate environment and build successful business relationships in a team environment Ability to effectively present information and respond to questions from senior management Must be confident, goal-oriented, self-motivated and a team player with a service-focused mindset Computer proficient with experience with Microsoft programs such as Outlook, Word, Excel, and PowerPoint Must have strong verbal and written communication skills Independent worker with a willingness to learn and take on new challenges OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 25 pounds, occasionally lift up 25 pounds Ability to pass pre-employment drug screen and background check #LI-AM1
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: *************************************************** 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).
$42k-66k yearly est. 5d ago
Temporary Document Control Support
Atricure 4.6
Atricure job in Mason, OH
This position will be responsible for the support of company-wide document control as part of Quality Systems. This role will assist in maintaining the documents and records for the company in compliance with regulations and international standards. This person will work primarily with the Document Control team and take direction from them and the Quality Systems Supervisor.
ESSENTIAL FUNCTIONS OF THE POSITION:
Scanning documents and use DocuWare software as the repository
Filing hard copies
Communicating any missing documents, files, issues to Document Control team
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
Strong organizational skills
Ability to communicate effectively (both verbal and written)
Ability to work independently
Ability to make decisions and use good judgment
Ability to collaborate and work successfully with others
Additional duties as assigned
BASIC QUALIFICATIONS:
Strong computer/data entry and communication skills with an emphasis on attention to details
Ability to use a copier/scanner
PREFERRED QUALIFICATIONS:
Experience with document software (e.g. DocuWare)
OTHER REQUIREMENTS:
Ability to stand for long periods of time
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
#LI-AM1
$26k-35k yearly est. 1d ago
Safety Specialist II
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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 Safety Specialist II will be responsible for safety-related aspects of clinical trials conducted by the AtriCure Clinical Affairs department. This person is responsible for coordinating and managing aspects of safety for assigned clinical trials. Responsibilities include upholding execution of safety related processes during the course of a trial as dictated by current country specific Regulations, Protocol, Safety Management Plan (SMP) as well as Standard Operating Procedures (SOP) and Work Instructions (WI). This position may assist in planning, start-up, execution, data collection, coding, and reporting safety data for clinical studies. This role is involved in collection and processing of clinical study adverse event data, assessment of data, coding, preparation for adjudication, tracking, reporting and analysis of safety data. This position works closely with multiple departments such as Clinical Science, Complaints, Regulatory Affairs, Medical Directors, CRAs, Investigative Sites, and external vendors. ESSENTIAL FUNCTIONS OF THE POSITION: Ensures compliance and adherence to safety aspects for assigned clinical trials including collection, processing, coding and tracking of (Serious) Adverse Events (AE/SAE) reports and adverse event documentation including safety narratives Coordinates and manages reconciliation of AE/SAEs, preparing cases for adjudication, writing event narratives, cleaning data, coding Medical Dictionary for Regulatory Activities (MedDRA) etc. Participates in the development of safety sections for documents such as clinical trial protocols, informed consents, case report forms, site selection materials, data collection and reporting instructions, investigator updates and other project-specific documents required for the conduct of assigned studies in accordance with current applicable regulations, good clinical practices (GCPs), and industry best practices pertaining to safety Provides input to and reviews the SMP and other materials required for conduct, and maintenance of assigned clinical studies for assigned studies in accordance with applicable regulations and best practices pertaining to safety Provides input toward SOP and WIs for the Clinical Affairs department Provides input in the review of interdisciplinary study-specific documents for consistency and compliance Ensures timely reporting of AEs, SAEs and UADE's, in accordance with applicable regulations, protocols, and company procedures. Ensures integrity and quality of safety data including reconciliation of safety data listings BASIC QUALIFICATIONS: Bachelor's degree or equivalent is required Minimum of two years of clinical safety experience is required Proficient knowledge of Microsoft Office suite Experience with writing of safety narratives Working knowledge of MedDRA terminology and its application Familiarity with EDC systems (e.g. Clindex) Skilled at working effective in a collaborative team environment Independently motivated, detail oriented, analytical and strong problem-solving ability Knowledge and understanding of FDA and Global Regulations and Guidelines for the conduct of clinical trials Ability to exercise judgment and determine appropriate action Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment, and manage competing deadlines. Exceptional verbal and written communication skills PREFERRED QUALIFICATIONS: Previous experience in Medical Safety, Clinical Research, and/or working with a Medical Device Sponsor company or CRO Experience with safety monitoring in medical device industry Previous experience working as a safety specialist within a cardiology therapeutic area Demonstrated success in collaborating with and communicating effectively across different functions ESSENTIAL JOB FUNCTIONS: Regularly walk, sit, and stand Occasionally bend and push/pull Regularly lift up to 25 pounds, occasionally lift over 25 pounds 25% travel possibility Position dependent upon candidate passing pre-employment physical/drug screen #LI-KF1
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: *************************************************** 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).
$52k-77k yearly est. 9d ago
Senior Product Sterilization Scientist
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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: This position is responsible for supporting the AtriCure Sterilization Programs, specifically in gamma radiation and/or ethylene oxide modalities, by providing technical and scientific expertise to the Quality Operations staff and internal AtriCure customers. The Senior Sterilization Scientist works within the prescribed GMP/ISO Standards and ensures compliance to applicable domestic and international regulations. The Senior Sterilization Scientist is tasked with leading or supporting projects such as sterilization cycle/process development, management of sterilization cycle validations, product sterilization adoptions, change control assessments, improving sterilization and product microbiology programs and ensuring on-going sterilization effectiveness. This position will be responsible for sterility assurance for routine processing and managing product bioburden and endotoxin programs. ESSENTIAL FUNCTIONS OF THE POSITION: Apply knowledge of sterilization process and the associated microbiological concepts and practices for terminally sterilized single-use devices, as required to comply with relevant ISO standards, industry guidelines, and national / international regulations. Act as a sterilization and microbiology subject matter expert (SME), by supporting new product development, changes to existing commercial products, and associated domestic and international regulatory filings. Guide product development teams with scheduling, budget estimates, deliverables, as needed to ensure project and product launch success, and compliance with applicable regulations, industry standards, and AtriCure business objectives. Provide technical solutions to product development and engineering teams using various fields of science and sterilization theory and practice. Lead cycle development, validation, requalification activities, as well as product-specific sterilization qualifications and adoptions. Manage, perform and document periodic product reviews and annual cycle reviews to determine impact on current sterilization family groups and sterilization cycle effectiveness. Recommend actions to be taken, as needed, to maintain program effectiveness. Analyze/review chemical, biological, or microbiological results for raw materials, in-process materials, validation samples and product release test samples (includes, bioburden, organism, EO/ECH residual levels, BI testing, etc.). Perform product release activities, as required. Guide teams through effective sterilization impact assessments within change control activities. Mentor team for approach to assessment and deliverables to meet effective, and consistent practice aligning with internal programs and external requirements. Accountable for maintenance, and improvement of sterilization, bioburden and endotoxin programs. Develop protocols and reports to document project, product, and process outputs. Support strategy, development and integration of new sterilization modalities into current programs and processes. Collaborate in the development and integration of upstream processes used to control biocontamination such as, product/component cleaning processes, facility cleaning and disinfection, and environmental controls. Lead internal and 3rd party investigations (i.e. dose audit failure, endotoxin product failures) in response to failures or negative trending within the program requirements. Support 3rd party quality system audits for relevant suppliers (ie, sterilization vendors, test laboratories). Deliver periodic internal technical training to AtriCure colleagues. Participate as needed in AtriCure CAPA, NCR, Deviation, HHE and Risk Management programs and complete actions and deliverables as assigned. Support department in administrative tasks such as, but not limited to; Liaison between AtriCure and 3rd party vendors for project scope, quotes, invoices, and training as needed to comply with AtriCure policies and procedures. Tracking/reporting expenditures against approved Purchase Orders. Maintain department electronic file system for retention of technical and business records, such as cycle specification, test specifications, and dose maps. Use electronic document management system(s) to write, review, edit and route technical and administrative documentation. Coordinate product and sample shipping to 3rd party vendors. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Ability to remain calm and respective and maintain productivity in fast paced situations Ability to make decisions and use good judgement Ability to prioritize various duties and multitask as required Ability to communicate effectively across all levels of the organization and work in cross functional teams Additional duties as assigned BASIC QUALIFICATIONS: Bachelor's degree in microbiology, life sciences or related field; and minimum of 5 years of sterilization work experience in a GXP regulated environment, such as medical device and/or pharmaceutical, OR an advanced college degree plus at least 3 years of relevant experience. Demonstrates technical expertise, through applied experience in at least one sterilization modality, i.e. Ethylene Oxide Sterilization or in Radiation Technologies (e.g., Gamma, X-Ray, E-beam). Knowledge of applicable external standards; ISO 13485, ISO 11135, ISO 11137, ISO 11737, AAMI TIR28 or TIR35, and related national and international medical device industry standards and regulations. Excellent writing and communication skills. Intermediate Microsoft Office Skills (Excel, Word, PowerPoint). Strong analytical and mathematical skills. Detail-oriented, with strong commitment to accuracy and completeness of work. Ability to work non-standard hours on occasion to support organizational and department objectives and commitments (e.g., audits, dunnage builds, project deadlines, etc.). Ability to travel up to 15%. Travel to supplier and service provider sites, other AtriCure offices or industry-specific meetings or conferences. PREFERRED QUALIFICATIONS: A current ASQ certification as a Quality Engineer, Quality Auditor, or Biomedical Auditor, or an equivalent certification from a comparable professional organization. A current certified sterilization specialist (CSS) designation by AAMI or similar professional organization, in at least one sterilization modality. Participatory experience with FDA inspections or ISO audits. Experience with regulatory requirements and submission processes for FDA, MDD/MDR, CMDR, and JPAL OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull Ability to regularly lift up to 25 pounds, occasionally lift over 50 pounds Ability to pass pre-employment drug screen and background check #LI-KN1
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: *************************************************** 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).
$83k-106k yearly est. 41d ago
Principal Manufacturing Engineer
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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.
This Position is located in Mason/Cincinnati OH and will be onsite. Must be able to commute or relocate to Cincinnati OH for this position to be considered. POSITION SUMMARY: A Principal Manufacturing Engineer is a high level, experienced manufacturing/process engineer and is accountable for developing and maintaining capable and stable manufacturing processes to meet product quality standards/requirements. The role is responsible for process development and improvement, and tooling and fixture development and improvement both internally at AtriCure, and externally at key suppliers. A principal manufacturing engineer may also be involved in development of process analytics for preemptive defect control, process documentation and process layout & material logistic flow. ESSENTIAL FUNCTIONS OF THE POSITION: Experienced member of the manufacturing engineering team responsible for the development, qualification, implementation and support of new manufacturing processes and equipment Design and develop fixtures in CAD prototypes for manufacturing and assembly Is considered a subject matter expert in at least 2 major areas of manufacturing engineering Ensures continuous improvement in process, cost, quality and production Responsible for leading/mentoring members of the Manufacturing/Process Engineering Teams Supports and drives a DFM (design for manufacturability) focused culture within the PD teams and the operations organization Supports and drives a Lean processes and continuous improvement culture within the PD teams and the operations organization Develop business, operational and financial strategies, plans and programs that foster the achievement of organizational objectives Translate broad strategies into specific objectives and action plans Read blueprints and interpret technical specifications and illustrations Drive multiple initiatives at a rapid pace, making thoughtful recommendations with available data ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable worksite attendance Ability to work under fast-paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: Bachelor's degree in Industrial Eng., Biomedical Engineering or Mechanical Eng. or equivalent is required 15+ years (10 years + Masters) of experience: Experience in development of new manufacturing processes and the tooling/equipment required to implement the processes Demonstrated ability to design in CAD and prototype manufacturing/assembly fixtures Knowledge base in Lean Processes and Continuous Improvement Experience in Design for Manufacturability Experience with medical device design and manufacture Experience with process validation Previous class II or class III Medical Device manufacturing experience Possess a strong knowledge of manufacturing processes and capabilities. Provide guidance in process and supplier selection when necessary. Self-motivated with strong time management skills Demonstrated ability to develop business, operational and financial strategies, plans and programs that foster the achievement of organizational objectives Ability to translate broad strategies into specific objectives and action plans Demonstrated possession of in-depth and current knowledge of industry best practices and the ability to implement the same Experience in technical report writing and verbal and oral communication skills Must be able to read blueprints and interpret technical specifications and illustrations Comfortable driving multiple initiatives at a rapid pace, making thoughtful recommendations with available data Active, high-energy communicator who drives a company vision/mission to align teams, critical resources, management, and stakeholders Creative thinker with exceptional process, analytical, management and relationship skills Problem solving/trouble shooting experience Ability to travel 10% OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 25 pounds Ability to pass pre-employment drug screen and background check #LI-RS1 #LI-ONSITE
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: *************************************************** 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).
$70k-86k yearly est. 9d ago
Clinical Research Associate II
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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 Clinical Research Associate II (CRA II) at AtriCure is a critical role within the Clinical Affairs department, responsible for site management and/or monitoring activities during clinical trial execution. This position involves working under moderate supervision to ensure compliance with study protocols and regulatory standards. The CRA II plays a pivotal role in maintaining the integrity of clinical data while adapting to the dynamic needs of different studies. Key Responsibilities: Site Management: Coordinate the collection and review of essential documents from clinical investigation sites in collaboration with study team personnel. Support site Qualification, Initiation, Interim and Close-Out training visits. Assist with scheduling of required training sessions (e.g., EDC, Protocol, Device) and support site nomination and qualification processes. Site Communications: Serve as the main point of contact for site communications and inquiries. Liaise with clinical study management, clinical development, site personnel, and CROs, escalating protocol or study related issues as necessary. Compliance: Ensure clinical study sites adhere to assigned study protocols and regulatory standards, notifying study management of any concerns. Data Management: Review and analyze data for accuracy and completeness. Manage the creation, resolution, and tracking of data queries. Monitoring: Conduct site monitoring visits (qualification, initiation, interim, and close-out) to ensure adherence to study procedures and regulatory requirements. Safety: Process product complaints and adverse events as reported, collaborating with safety specialists to gather necessary materials for CEC meetings. Study Management: Assist in the development of study-related materials, including patient recruitment materials and newsletters. Facilitate ordering of clinical study devices, including verification and tracking of the devices to ensure proper receipt and storage at study sites Coordinate activities with study-specific committees, vendor services, and core labs. Other Duties: Ensure appropriate translations for study documents. Contribute to process improvement initiatives and department activities. Leadership & Development: Focus on self-development with opportunities to mentor entry-level professionals. Engage in continuous learning and professional development in clinical research areas. Qualifications and Experience: Bachelor's degree with a minimum of 2 years of clinical research experience. Strong organizational and communication skills with an ability to work effectively in a team. Proficiency in Microsoft Office Suite and familiarity with clinical data management systems. Willingness to travel between 10-75% of the time. #LI-KN1
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: *************************************************** 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).
$55k-81k yearly est. 60d+ ago
Law Clerk
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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 person in this position will work directly with AtriCure attorneys and other department personnel on the completion of legal department objectives key to AtriCure business. The ideal candidate must be able to work independently while exhibiting robust command of basic contract principles, legal research and drafting, as well as excellent attention to detail. ESSENTIAL FUNCTIONS OF THE POSITION: Perform legal research, fact-finding, and drafting under the direction of attorneys and other department personnel. Review written agreements, identifying key contract terms and data, while understanding important contract concepts and principles. Enter, validate or correct data contained within various systems, using source documents for comparison. Assist with important department objectives key to the overall business. Other duties as assigned, depending upon candidate's unique skillsets. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Ability to work under fast paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: Must currently be enrolled in law school, and have satisfactorily completed Contracts I & II, Legal Research and Legal Writing Excellent attention to detail Problem-solving / decision-making skills Must be confident, goal-oriented, self-motivated and a team player Computer proficient Outstanding organizational skills Independent worker with a willingness to learn PREFERRED QUALIFICATIONS: Contract management experience including the entirety of the contract lifecycle OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds Ability to pass pre-employment drug screen and background check #LI-KF1
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).
$45k-60k yearly est. 31d ago
Quality Inspector II - RMI
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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: Quality Inspector II, RMI is responsible for ensuring that incoming components and raw material are inspected properly and comply with applicable specifications. Inspections are performed using a variety of mechanical and electrical inspection equipment as required by inspection instructions. This individual is responsible for all documentation required by the quality system, and ensuring all documentation is complete and accurate. The Quality Inspector is responsible for the quality of their work and meeting all Quality System requirements for the tasks assigned. ESSENTIAL FUNCTIONS OF THE POSITION: Inspection of incoming components and raw material per AtriCure Quality Systems procedures Completion of inspection data and other documentation necessary to release materials to internal and external operations or inventory. Reporting non-conforming materials and initiating a Non-conformance Report when required per AtriCure's Quality System procedures. Review product purchase orders and certifications for accuracy and completeness Supporting Rework activities as required by AtriCure's Quality System procedures Ensure all appropriate activities are within compliance to AtriCure's Quality System and policies Assist in completion of First Article Inspections as requested Assist in mentoring of Level 1 inspectors Other duties as necessary and assigned by the Quality Supervisor BASIC QUALIFICATIONS: High School graduate or equivalent. 2+ years experience with common inspection/testing equipment and gauges (Ruler/Scale, Tape Measure, Calipers, Micrometers, Pin gauges, Drop/Dial Indicators, Height Gauge, etc.) Ability to read technical specifications, blueprints and drawings (ASME Y14.5 & ASME Y14.100) Working knowledge of GD&T (ASME Y14.5 1994 or greater) (Datums, Positions, Flatness, Perpendicularity & Parallelism) Experience with advanced/uncommon inspection equipment and gauges (Sine plate Thread Micrometer, Universal Micrometers, hardness tester, profilometer, durometer, etc.) Experience with pneumatic, electrical and environmental testing equipment (Multimeter, pressure gauge, flowmeter, temperature meter) Experience with CNC Vision system operation (OGP, Keyence, Starrett) (MeasureMind 3D, Zone-3, Keyence IM-8000) Strong computer/data entry, report writing, and communication skills (Microsoft Excel, Word & Outlook) Problem solving/trouble shooting experience Specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus PREFERRED QUALIFICATIONS: Advanced knowledge of GD&T (ASME Y14.5 1994 or greater) 2+ years experience with CNC Vision System operation (OGP, Keyence, Starrett) (MeasureMind 3D, Zone-3, Keyence IM-8000) 2+ years experience with CMM operation (PolyWorks with PH10M and Nikon Laser) Experience with tensile/strain and other material testing (Instron, BlueHill Universal) 2+ years experience in the Medical Device industry ASQ, CQI, or CQT Certification OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 10 pounds, occasionally lift up to 25 pounds Ability to use hands to grasp and manipulate small parts in a repetitive motion On Demand overtime to meet production schedule may be required Ability to pass pre-employment drug screen and background check #LI-AM1
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: *************************************************** 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).
$46k-54k yearly est. 15d ago
Senior Principal Perioperative Education Specialist
Atricure, Inc. 4.6
Atricure, Inc. job in Cincinnati, 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 cryo ICE cryo SPHERE 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 Principal Perioperative Education Specialist will be responsible for developing, expanding and optimizing a standardized clinical training pathway to support safe and effective adoption of our innovative solutions. They will provide "best practices" from leading healthcare professionals and centers for perioperative protocol considerations through the patient continuum. The role places a strong emphasis on optimizing the patient experience, advancing multimodal pain management strategies, and driving measurable improvements in clinical and quality outcomes. ESSENTIAL FUNCTIONS OF THE POSITION: Lead and orchestrate strategic program implementation for minimally invasive thoracic and cardiac approaches, open concomitant programs, and lower extremity amputation procedures, demonstrating exceptional leadership in optimizing patient care management along the pathway - including disease state management, evidence-based anticoagulation and advanced pain management strategies that enhance patient recovery and satisfaction. Spearhead the development and execution of a comprehensive, forward-thinking educational program targeting clinicians along the patient pathway, (PAT/ICU/step-down units, office-based staff and operating room teams) within assigned or multi-regional geography, with an emphasis on improving patient care coordination, comfort and overall experience. Consistently demonstrates a commitment to advancing perioperative patient management techniques and a deep understanding of the company's products. Drive the creation and dissemination of cutting-edge clinical best practice resources for internal and external training, and program development, including algorithms, multimodal pain management protocols, and enhanced recovery pathways aligned with regulatory standards and latest clinical evidence. Champion the design and continuous enhancement of standardized clinical training pathways that integrate pain management and patient experience optimization as central components of safe and effective adoption of AtriCure innovative solutions. Cultivate and strengthen strategic partnerships with key stakeholders- including clinicians, hospitals, and other influential entities- to advance perioperative education initiatives that support both clinical excellence and patient centered outcomes. Maintain expert-level of knowledge of AtriCure products, procedures, current literature and emerging trends to inform strategy and support evidence-based education. Ensure compliance leadership by refining documentation processes, optimizing internal record systems, and adhering to compliance standards. Provide mentorship and inspire cross-functional teams, fostering a culture of excellence, innovation, and accountability, while driving transformative initiatives that elevate both the clinical education impact and the overall patient journey. Able to provide coaching, training and onboarding of new team members as appropriate. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Delivery of formal and informal presentation with Q&A/objection handling 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 Appropriate documentation and customer response time Additional duties as assigned BASIC QUALIFICATIONS: Bachelor's degree in a related field (e.g., Nursing, Health Sciences, or Biomedical Engineering); advanced degree preferred. Minimum of 5 years clinical experience. Minimum of 3 years medical device or pharma industry experience. Or, minimum of 7 years medical device or pharma industry experience. Must exhibit a thorough working knowledge of typical hospital policies. Strong knowledge of perioperative patient management, minimally invasive approaches, and open concomitant procedures. Ability to work and communicate effectively with all levels of hospital staff. Excellent communication and presentation skills, with the ability to tailor content to various audiences. Ability to work effectively and diplomatically with internal personnel to execute Company strategy, including senior management and sales personnel. Proficient with Outlook and the Microsoft Office suite, including Teams, Word, Excel and PowerPoint. Experience with Customer Relation Management (CRM) and expense tools. Ability to work independently and as part of a team, with strong project management skills. Ability to travel 75%, including overnights and occasional weekends. PREFERRED QUALIFICATIONS: Experience in cardiac procedures with Atrial Fibrillation and left atrial appendage management. 5 years clinical experience in the inpatient care unit with cardiac electrophysiology, cardiovascular, interventional, or critical care experience. Foundational knowledge of anticoagulation therapy. Experience with sophisticated clinical pathways and/or enhanced recovery programs. Experience using the Company's products as an end-user. OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand for up to 8 hours at a time Ability to occasionally bend and push/pull as needed Ability to regularly lift up to 40-50 pounds Ability to pass pre-employment drug screen and background check #LI-CM1
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: *************************************************** 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).
$76k-101k yearly est. 60d+ ago
Senior Infrastructure Engineer
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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: This position will serve as an integral player within AtriCure's Infrastructure and IT Operations function. The successful candidate will perform engineering and IT operations functions for Enterprise level on-premise and Cloud-based IT Infrastructure platforms required for AtriCure to operate its business. ESSENTIAL FUNCTIONS OF THE POSITION: Engineering and support services for Microsoft related technologies including Windows, Active Directory, Azure (IaaS, PaaS), Entra ID, Intune and M365 platforms. Engineering and support services for on-premises Infrastructure platforms including physical and virtual servers, shared storage, networking devices, and IoT devices. Engineering and support services for Cloud and on-premises backup and disaster recovery platforms. Administration of Infrastructure centric applications including patch and vulnerability management. Performing upgrades of Infrastructure equipment (firmware) and Infrastructure applications following prescribed change management and regulatory controls. Acting as engineering liaison for outside vendors supporting Infrastructure platforms. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance 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 After-hours support of Infrastructure platforms including routine maintenance windows and resolution of incidents impacting company operations Collaborating with the IT Enterprise Application, Delivery, and Cybersecurity teams through project meetings and planning sessions Recommending hardware and applications upgrades to IT Infrastructure leadership Monitoring all key infrastructure platforms and driving resolution of issues Provide Tier3 troubleshooting to helpdesk Supporting all regulatory and quality requirements by following guidance or SOP Additional duties as assigned BASIC QUALIFICATIONS: Bachelor's degree required or demonstrated equivalent combination of education, training and experience 4+ years IT Infrastructure engineering or administration experience Demonstrated strong verbal and written communication skills along with ability to work independently, manage prioritization and multi-task Demonstrated knowledge of networking topologies such as LAN/WAN, SD-WAN, DNS, DHCP, and 802.11 Working knowledge of Windows Server 2016-2022 in both physical and virtual environments with experience managing Windows Roles and Features Ability to travel 10% PREFERRED QUALIFICATIONS: Advanced knowledge of Cisco networking including switching, wireless and firewalls Advanced knowledge of HPE data center hardware platforms including Proliant rackmount and Nimble Flash Array Knowledge of advanced networking protocols such as BGP, EIGRP, OSPF, IPsec, GRE, VXLAN, iSCSI, RADIUS and others Advanced knowledge of Windows Server Roles and Features such as Failover Clustering, IIS, and RDS Advanced knowledge of backup technologies including Veeam and Azure Backup. Experience with next generation backup and DR platforms like Cohesity and Zerto advantageous Advanced knowledge of Active Directory and Entra ID including Group Policy, Sites and Services, Replication, LDAP and AAD Sync Knowledge of Azure IaaS offerings such as Azure Virtual Machines, Storage Accounts, and Networking resources Knowledge of basic PowerShell scripting and connecting to Microsoft Online platforms Knowledge of ITIL framework and development/support of associated processes Previous work experience in a regulated environment CCNA, AZ-104, MS-102, certifications (or similar) OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to pass pre-employment drug screen and background check #LI-KN1
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: *************************************************** 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).
$88k-115k yearly est. 44d ago
Process Engineer
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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 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. ESSENTIAL FUNCTIONS OF THE POSITION: Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include: 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 Drive a lean, KPI-driven, and continuous improvement culture across the department Implement lean principles and methodologies to optimize manufacturing processes. Lead continuous improvement initiatives, including value stream mapping (VSM), 5S and Kaizen events Analyze production data to identify bottlenecks, inefficiencies, and opportunities for streamlining 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 Has knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc. Understands GD&T and how to properly apply it to yield the 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. Understand of error proofing, poke-yoke Working knowledge of Manual and Automated Assembly Systems and Technologies Act as a lean champion to train and mentor others on lean concepts and tools as needed MANUFACTURING PROCESS KNOWLEDGE Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) including low to medium volume manufacturing processes Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, using SPC in resolving/improving productivity and efficiencies etc. Work with outside suppliers to define, document, analyze and qualify their manufacturing processes. 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. Understand life cycle costs and cost benefit analysis. 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. Working understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t-Tests, acceptance plans) Able to work in a controlled environment where gowning and strict adherence to clean room procedures are required TOOLING AND EQUIPMENT Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts 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 Working knowledge of Manual and Automated Assembly Systems and Technologies, including both mechanical and control systems Experienced with mechanical equipment and gauges such as microscopes, soldering stations, ovens/furnaces, UV curing stations, Instron, calipers and other measurement gauges VERIFICATION AND VALIDATION 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 Understanding of Test Method Validation, IQ, OQ, PQ approach as defined by AtriCure Quality System MANUFACTURING LOGISTICS Understand supply chains, lead times, and raw material availability Able to construct Bills of Material, with proper unit of measure and inventory points Working knowledge of MRP and other requirement planning systems Able to conduct time studies and analyze cost variances TROUBLESHOOTING AND ROOT CAUSE ANALYSIS 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 DOCUMENTATION 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 ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: 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 BASIC QUALIFICATIONS: Bachelor's degree in engineering (mechanical, industrial, or related field) required or demonstrated equivalent combination of education, training, and experience 3 + 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% PREFERRED QUALIFICATIONS: Medical device industry experience Lean Six Sigma certification (Green Belt (or) Black Belt) Demonstrated lean manufacturing process implementation experience. Proficiency in lean tools such as 5S, Kanban, VSM etc. Solid understanding of Industry regulations as it pertains to medical devices OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 10 pounds, occasionally lift over 50 pounds Ability to pass pre-employment drug screen and background check #LI-KF1
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: *************************************************** 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).
$57k-69k yearly est. 19d ago
Finance Reporting Manager
Atricure 4.6
Atricure job in Mason, OH
This position serves as the lead for the Reporting function, providing oversight and direction for SEC reporting, international statutory reporting, and share-based compensation accounting. The role includes managing the reporting team, ensuring high-quality deliverables, and coordinating audit support, working closely with the accounting team on these tasks along with process improvement initiatives. The Manager, Reporting position must also take initiative to stay knowledgeable of current and changing accounting standards and SEC reporting requirements. Additionally, this position assists in technical accounting research, manages certain general accounting areas and supports special projects as requested by management.
ESSENTIAL FUNCTIONS OF THE POSITION:
Lead the preparation of external financial statements in accordance with SEC rules and US GAAP.
Manage SEC filings, including Forms 8-K, 10-Q, 10-K, 3 and 4; proxy statements and Conflict Minerals filing.
Direct international statutory reporting, ensuring compliance with local regulations and timely submission of required reports.
Oversee share-based compensation accounting, including valuation, expense recognition, and related disclosures.
Oversee assigned general accounting areas, including journal entry and account reconciliation review.
Drive process improvement initiatives within the reporting and accounting function to enhance efficiency, effectiveness, accuracy, and compliance.
Supervise and mentor the reporting team, providing guidance, training, and performance feedback.
Work cross-functionally across the business to ensure timely and appropriate financial reporting of key business activities.
Provide audit and tax support, including coordination with external auditors.
Prepare technical accounting position memos and perform technical accounting research, including assessment of impact and implementation of new accounting standards, as needed.
Collect, validate and analyze data required for compliance with sustainability reporting standards and organizational sustainability goals.
Monitor evolving sustainability frameworks and prepare for potential reporting initiatives, ensuring readiness for future disclosures.
Special projects at request of management.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Consistent and reliable worksite attendance is required at a minimum rate of 60%, with potential increases during peak reporting periods.
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
BASIC QUALIFICATIONS:
Bachelor's degree required, preferably in accounting, or demonstrated equivalent combination of education, training and experience
At least 5 years of combined experience in financial accounting and auditing or SEC reporting
Experience and demonstrated success managing personnel
Effective use of Excel, Word, PowerPoint and reporting systems
Effective writing and verbal communication skills
Self-motivated, high initiative and able to work with minimal supervision
Ability to travel up to 10%
PREFERRED QUALIFICATIONS:
SEC reporting experience
Accounting / US GAAP knowledge
Public accounting experience at the senior or higher level and CPA certification
Effective project management skills driven to meet deadlines
Workiva system experience
OTHER REQUIREMENTS:
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
#LI-AM1
$97k-123k yearly est. 11d ago
Senior Talent Acquisition Partner: Sales
Atricure, Inc. 4.6
Atricure, Inc. job in Cincinnati, 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 cryo ICE cryo SPHERE 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 Commercial Talent Acquisition Partner has deep expertise in medical device sales recruiting to support and scale a high-performing commercial organization. This is a strategic, full life cycle recruiting role requiring strong partnership with Sales Leadership and a passion for delivering an exceptional candidate experience. The TA Partner will execute talent acquisition strategies and administer recruiting programs that result in the selection of top-tier sales talent. This individual will serve as a trusted advisor to sales leaders, leveraging market insights, data, and best practices to attract and hire talent that drives business growth. ESSENTIAL FUNCTIONS OF THE POSITION: Full Life Cycle Recruiting Own and execute the full life cycle recruiting process for medical device sales roles, including territory managers, account executives, clinical specialists, sales leadership, and other commercial roles. Manage multiple high-priority requisitions simultaneously while maintaining quality, speed, and compliance. Lead intake sessions with hiring managers to define role requirements, success profiles, and hiring strategies. Strategic Partnership with Sales Leadership Partner closely with Sales Leaders and Hiring Managers as a strategic talent advisor. Consult on position-specific recruiting and selection strategies, including talent availability, competitive intelligence, and compensation considerations. Influence hiring decisions through data-driven insights and best-in-class recruiting practices. Talent Acquisition Strategy & Execution Execute and influence talent acquisition strategies aligned with business objectives and workforce plans. Identify, develop, and deploy sourcing strategies to attract top medical device sales talent. Proactively build pipelines for critical and recurring sales roles. Sourcing & Employer Branding Champion the company's employment brand to candidates and employees. Utilize a variety of sourcing methods including LinkedIn Recruiter, referrals, networking, industry events, in person and virtual career fairs, and direct outreach. Represent the organization professionally in the medical device talent market. Candidate Experience Deliver a high-touch, best-in-class candidate experience throughout the recruitment lifecycle. Act as the primary point of contact for candidates, ensuring clear communication, transparency, and engagement. Partner with internal stakeholders across various departments to ensure a seamless interview and selection process. Compliance, Offers & Reporting Ensure compliance with EEO, OFCCP, and all applicable employment laws and regulations. Complete offer activities, including offer preparation, presentation, and negotiation in partnership with hiring and compensation teams. Maintain accurate documentation and data within the Applicant Tracking System (ATS). Process Improvement & Programs Identify opportunities to improve recruiting processes, tools, and programs. Contribute to or lead initiatives that enhance efficiency, quality of hire, and diversity outcomes. Track and analyze recruiting metrics to measure effectiveness and guide continuous improvement. BASIC QUALIFICATIONS: Bachelor's degree or equivalent combination of education and experience 4+ years of full life cycle recruiting experience with required medical device sales recruiting background Proven ability to assess sales talent using quota attainment and sales performance metrics Strong expertise in sourcing and recruiting tools, including ATS platforms, resume databases, internet search, and social networking Demonstrated ability to build trust and consult with hiring managers to solve complex talent challenges Excellent communication, presentation, organizational, and time-management skills Ability to navigate sensitive, complex, or politically nuanced situations with sound judgment Experience managing relationships with third-party executive, retained, or contingent search partners Ability to manage multiple priorities in a fast-paced environment and adapt creatively to changing business needs Ability to travel up to 10% OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to pass pre-employment drug screen and background check #LI-LH1
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: *************************************************** 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).
$61k-76k yearly est. 13d ago
Engineering Intern
Atricure, Inc. 4.6
Atricure, Inc. job in Mason, 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 cryo ICE cryo SPHERE 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 Co-op/Intern is a college or college-bound student pursuing an engineering or quality-related degree and is interested in gaining experience in engineering, manufacturing, assembly techniques, process development, design principles and philosophies, along with quality assurance. The Co-op/Intern will support engineering, including both sustaining engineering and new product activities. The Co-op/Intern works quarter to quarter on a wide variety of projects. ESSENTIAL FUNCTIONS OF THE POSITION: Responsible for testing, following guidelines described in the AtriCure Quality System, including test report writing Perform research for engineering as assigned by a supervisor Write process validation/qualification protocols, perform qualification activities, and analyze/document the results Design test protocols, equipment and systems as assigned by supervisor Responsible for supporting engineering activities and other company functions as assigned by supervisor Document and install process equipment Identify assembly process or equipment improvements Support pilot build activities including production associate training, component and assembly flow, root cause analysis and inspection data organization/collection Document all work in compliance with AtriCure Quality System requirements & corporate policies BASIC QUALIFICATIONS: Currently pursuing an undergraduate degree in Biomedical, Mechanical, or Electrical Engineering High School diploma Desire to initiate a mechanical/manufacturing/engineering career in future OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds Ability to pass pre-employment drug screen and background check 5% travel possibility #LI-DNI
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).