ALung is now proud to be part of LivaNova.

Careers

Interested in joining the team? Find our current openings below.


Position Title: Solidworks Drafter
Department: Manufacturing
Reports To: Manufacturing Manager 
Exempt/Non Exempt: Exempt                                                                                                                       
Last Reviewed Date: March 29, 2021

To Apply, Please Send Resume to: hr@alung.com

POSITION SUMMARY: Responsible for preparing detailed drawings and documentation of machinery and mechanical devices, including dimensions, fastening methods, manufacturing process routing, and other required information in a medical device manufacturing environment.

POSITION QUALIFICATIONS

  • A minimum of three years’ experience with Solidworks and Solidworks PDM.  Solidworks PDM Admin experience preferred.
  • Must be proficient in the following areas:
    • Strong SolidWorks Drafting Experience
    • Ability to Design and Model 3D parts in Solidworks
    • Creating and Maintaining Bill of Materials
    • Experience in making design changes/updates to existing SolidWorks drawings
    • Ability to interact and communicate successfully with customers, Project Engineers, Designers, and Production personnel.
    • Prepare clear, complete, and accurate drawings
  • Familiarity with FDA (QSR) and ISO-13485 regulations as applied to the manufacture of medical devices preferred.
  • Experience with Microsoft Office products, MRP system interaction and electronic data entry.
  • Associates Engineering or Technical Degree
  • Strong organizational, analytical, and communication skills as well as attention to details.
  • There is only occasional travel (< 5%) required for this position.

KEY RESPONSIBILITIES:

  • Design and model 3D detailed drawings and documentation of machinery and mechanical devices in Solidworks.
  • Revise and update existing SolidWorks drawings
  • Create and maintain Bill of Materials
  • Collaborate and communicate with personnel both inside and outside the company.
  • Other duties as assigned.

POSITION DIMENSIONS:

  • Drafter is expected to use sound judgment to maintain the documentation and processes to the highest levels of quality.
  • Drafter will be comfortable and competent with detailing and updating Solidworks files for multiple projects.
  • Drafter is expected to adhere to all regulatory requirements and processes.

EQUIPMENT:

Works with desk and cellular phones, personal computer, and other manufacturing tools and equipment.

WORKING CONDITIONS:

Work environment varies from office with a low to moderate noise level to the manufacturing/loading dock with a moderate/loud noise level.

PHYSICAL DEMANDS

Job activities require mobility and stamina involving a significant amount of walking, standing, and sitting; manual dexterity to carry, reach, manipulate as well as to write, telephone, use computer keyboard, etc.; stooping and kneeling to pick up and carry equipment; and the ability to communicate clearly.  Lifting requirements are normally up to 25 pounds but may exceed that on occasion.

To Apply, Please Send Resume to:  hr@alung.com



Position Title: Field Service Engineer
Department: Service and Logistics
Reports To: Customer Support Manager                                                             
Exempt/Non Exempt: Exempt                                                                                                                       
Last Reviewed Date: March 22, 2021

To Apply, Please Send Resume to: hr@alung.com

POSITION SUMMARY: 

As a member of the Service and Logistics team, the Field Service Engineer is responsible for providing technical expertise and support to colleagues, current clinical trial sites, customers and/or potential customers.  Works under general direction of the Customer Support Manager and with Service teammates to install, service, and support clinical sites during a large pivotal FDA clinical trial within the assigned geography. Performs work that involves a high degree of independence.  Exercises independent judgment in planning, organizing, and performing work. Seeks to continually improve servicing capabilities.

POSITION QUALIFICATIONS:

  • Must be fluent in English.
  • Technical degree in a field such as electronics, computer science, applied technology, etc.
  • Proven experience in the field will be considered in lieu of education.
  • A minimum of five years industrial experience in medical devices servicing is required (FDA and/or EU standards).
  • Excellent organizational, time management, and prioritizing skills. Must demonstrate the ability to manage multiple tasks in a disciplined, well-organized manner.  Prioritizes and meets deadlines in timely manner.  Accustomed to tight deadlines.
  • High level of technical expertise in computer hardware/software, electronics, and mechanical systems.
  • Results oriented self-starter who can identify necessary goals and actively pursue them.
  • Strong analytical skills, writing skills, communication skills and attention to detail required.
  • Excellent interpersonal verbal, written and presentation skills with ability to effectively communicate at multiple levels and to large groups within and outside the organization.
  • Capable of building strong working relationships with internal/external customers.
  • Capable of working unpredictable schedule that may occasionally change on short notice due to patient changes and or physician delays.
  • Strong sense of urgency.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Ability to travel up to 75% within assigned region and/or outside assigned region including international locations.

KEY RESPONSIBILITIES:

  • Provide proactive customer and technical support, installation, repair, and training services to customers on-site and remotely.
  • Accurately document service activities per ALung’s procedures.
  • Candidate is expected to support internal customers such as engineering and manufacturing.
  • After hours call support and activities.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, clinical sites, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned. Candidate will be an individual contributor with potential for advancement as company grows.
  • Ideal candidate will be comfortable and competent with handling authority and making decisions.

POSITION DIMENSIONS:

  • Candidate is expected to use sound independent judgment to drive a project from initial conception through implementation.
  • Ideal candidate will be comfortable and competent with handling authority and making decisions.
  • Decisions and actions of candidate will directly impact the design and development of medical devices. Considerable resources will be allocated to candidate’s efforts, and errors will deeply impact the success of ALung’s endeavors.
  • The Field Service Engineer position falls under the ALung Engineering Levels for job titles and supervisory responsibilities.

EQUIPMENT:

Works with cellular phone, personal computer, and product line technology.  Has responsibility for field service tool kit and spare part kits.  Operates a motor vehicle for trips to various company sites and outside vendor, field, and customer locations; and to commute to various airports for airline travel.

WORKING CONDITIONS:

Work environment varies from office/field including physician offices, procedure rooms and hospital operation rooms, intensive care units with a low to moderate noise level to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

PHYSICAL DEMANDS

Job activities require mobility and stamina involving a significant amount of walking, standing climbing stairs and sitting; manual dexterity to carry, reach, manipulate, handle and demonstrate company products as well as to write, telephone, use computer keyboard, etc.; stooping and kneeling to pick up and carry equipment; and the ability to communicate clearly. . Lifting requirements are normally up to 25 pounds but may exceed that on occasion.

To Apply, Please Send Resume to:  hr@alung.com



Position Title:  Engineering Manager
Department: Engineering
Reports To: VP of New Technology                                                                          
Exempt/Non Exempt:  Exempt                                                                                                                 
Last Reviewed Date: March 15, 2021

To Apply, Please Send Resume to:  hr@alung.com

POSITION SUMMARY: 

ALung Technologies, a leader in extracorporeal respiratory support technologies, is recruiting an Engineering Manager to lead company-wide engineering activities at ALung’s Pittsburgh, PA headquarters. The Engineering Manager will lead a team of 5-10 engineers in research, product development, and sustaining engineering efforts to advance ALung’s respiratory support products in the marketplace. The Engineering Manager will:

  1. Manage complex engineering projects from concept to commercialization in a dynamic and fast-paced work environment.
  2. Collaborate with regulatory, quality, manufacturing, and clinical science teams to meet project deliverables and maintain superior safety and efficacy of ALung’s products.
  3. Manage development and maintenance of both electromechanical and blood contacting product lines.
  4. Mentor engineering staff and cultivate a culture of professionalism and operational excellence.

POSITION QUALIFICATIONS:

  • B.S. in Mechanical Engineering, Electrical Engineering, Software Engineering, Bioengineering, or other relevant engineering discipline.
  • 10+ years’ professional experience in medical device development.
  • Demonstrated leadership in managing interdisciplinary engineering teams and completing complex projects on time and within budget.
  • Experience in Class II and III medical device development, including design controls, risk management, and regulatory filings (510k, PMA, CE mark).
  • Expertise and significant experience in two or more of the following:
    1. Electromechanical medical device development including embedded software and hardware, systems engineering, and usability.
    2. Blood contacting medical device development including biocompatibility, sterilization, packaging, and materials science.
    3. Mechanical design, CAD (e.g. Solidworks), precision machining, and design for manufacturability.
    4. Quality Management Systems (e.g. ISO 13485) and regulatory compliance audits.
  • Ability to work effectively with diverse, cross-functional teams in a dynamic and fast-paced work environment.
  • Excellent oral and written communications skills.
  • Demonstrated independence and decision-making with minimal supervision.

KEY RESPONSIBILITIES:

  • Lead company-wide engineering activities for interdisciplinary research, product development and sustaining engineering projects.
  • Complete projects on time and within budget while maintaining strict adherence to quality system procedures and regulatory compliance.
  • Provide technical and scientific leadership to solve challenging engineering problems across numerous functional areas, including, but not limited to electromechanical design, embedded software and hardware, usability, biomaterials, pre-clinical models, hydrodynamic blood pumps, sterile packaging, and design for manufacturability.
  • Provide technical and scientific leadership on experimental design, execution, data analysis, and statistical methods.
  • Interpret, contextualize, and communicate complex engineering data to technical and non-technical stakeholders.
  • Liaison with contract manufacturers, test vendors, and supply chain partners.
  • Provide strategic guidance on design and development of next generation products and product improvements.
  • Collaborate with manufacturing staff on process design and validation, statistical process control, and sustaining engineering activities.
  • Collaborate with ALung’s clinical, regulatory, quality and business development staff to develop and implement strategies for company-wide operational excellence.

PHYSICAL DEMANDS AND WORKING CONDITIONS: 

On site employment at ALung’s Pittsburgh, PA office is required. Day to day work includes desk and personal computer work. Job activities require the employee to sit, stand, climb stairs, manual dexterity to carry, reach, manipulate, handle and demonstrate company products as well as to write, telephone, use computer keyboard, etc., speak and hear. Vision abilities required for this job include close vision. .Job activities may also include laboratory work, participation in pre-clinical studies, operation of electromechanical equipment and working in a clean room environment. Occasionally domestic travel may be required as needed.

To Apply, Please Send Resume to:  hr@alung.com



Position Title:  Clinical Science Analyst
Department: Clinical Science
Reports To: Senior Clinical Engineer                                                                        
Exempt/Non Exempt:  Exempt                                                                                                                            
Last Reviewed Date: April 8, 2021

To Apply, Please Send Resume to:  hr@alung.com

POSITION SUMMARY: 

ALung Technologies, a leader in extracorporeal respiratory support technologies, is recruiting a Clinical Science Analyst to join our growing Clinical Science team. The Clinical Science Analyst will lead the management, analysis, and dissemination of clinical performance data for ALung products to support company-wide regulatory, commercialization and engineering activities. This position is focused on the research and analysis of the clinical performance of medical devices (i.e. product safety, adverse events, and physiologic and clinical efficacy data). The Clinical Science Analyst will:

  1. Create tailored analyses, visual data displays, and dashboards of clinical performance data for ALung products for technical and non-technical audiences
  2. Support the preparation and analysis of scientific content for regulatory submissions
  3. Develop, implement, and maintain database systems for organizing and analyzing complex clinical performance data for ALung products
  4. Serve as the company-wide subject matter expert for best practices in data management and biostatistics
  5. Assist in the growth of clinical science as a core strategic mission at ALung.

POSITION QUALIFICATIONS:

  • B.S. in Public Health, Biomedical Engineering, Biostatistics, or other Health Sciences related field. M.S. degree preferred.
  • Minimum 3 years relevant professional experience.
  • Experience conducting scientific literature reviews and extracting data from academic literature.
  • Expertise in the development and maintenance of databases for medical device clinical performance data.
  • Expertise with R, Tableau, or similar data analysis, processing, and visualization software.
  • Experience with supporting regulatory filings (FDA, EU) is strongly preferred.
  • Experience with clinical or medical device research is strongly preferred.
  • Expertise in statistical analyses of clinical data preferred.
  • Team oriented – ability to work effectively with diverse, cross-functional teams.
  • Excellent oral and written communications skills.
  • Experience in communicating scientific data with rigor and clarity to business, technical, and medical audiences.
  • Demonstrated independence and decision-making with minimal supervision.

KEY RESPONSIBILITIES:

  • Support clinical science activities for ALung’s products, medical device clinical research, and regulatory requirements.
  • Develop, implement, and maintain database systems to collect, manage, analyze, and disseminate device clinical effectiveness and safety data.
  • Support the development and improvement of clinical performance data collection and analysis tools.
  • Conduct and summarize scientific literature reviews for regulatory filings
  • Support ALung’s clinical and regulatory staffs to ensure accuracy and compliance of databases for medical device clinical performance data.
  • Create data analyses and dashboards to identify and monitor data trends, to meet regulatory requirements, and for conference proceedings and publications.
  • Collaborate with biostatisticians and ALung Clinical Science team to develop, write and review clinical study protocols, data collection forms and statistical analysis plans.
  • Identify and implement appropriate statistical methods and analyses using statistical analysis software (ie R, SAS, SPSS)
  • Collaborate with ALung’s clinical, regulatory, and engineering staffs to maintain ALung as a market leader in clinical science.

PHYSICAL DEMANDS AND WORKING CONDITIONS: 

Day to day work includes desk and personal computer work. Job activities require the employee to sit, stand, climb stairs, manual dexterity to carry, reach, manipulate, handle and demonstrate company products as well as to write, telephone, use computer keyboard, etc., speak and hear. Vision abilities required for this job include close vision.

In-person employment at ALung’s Pittsburgh headquarters is preferred, but fully-remote employment will be considered. For remote candidates, periodic travel to ALung’s Pittsburgh office may be required.

To Apply, Please Send Resume to:  hr@alung.com



Position Title: Clinical Research Project Manager
Department: Clinical Affairs
Reports to: VP, Clinical Operations                                                                                                                       
Location: Remote
Travel %: <25%

 Apply Now

POSITION SUMMARY: 

The Clinical Research Project Manager is a critical member of the clinical research team, leading projects to obtain Regulatory approvals for new indications or products, as well as support current process of obtaining solid clinical data.

KEY RESPONSIBILITIES:

  • Accountable for data management, CRF and database development process, accurate and timely quality data collection and monitoring, continual CRO monitoring of eDC, QC, reporting, etc.
  • Detect project risks and capable of addressing with mitigation plans and alternative solutions
  • Work with investigative sites/CRO to ensure subject safety in all areas of clinical research, following procedures to report SAEs and UADEs to clinical and regulatory management
  • Maintain study-integrity according to data protection plans
  • Supplemental support for trial committees including DSMB, CEC, TSC, etc.
  • Oversee and contribute to development of key study documents including, but not limited to study protocols and protocol synopses, protocol amendments, study plans and procedure manuals, project tools, informed consent forms and clinical study reports.
  • Oversee writing clinical reports
  • Oversee publications of peer-reviewed manuscripts, case reports, meeting presentations and whitepapers
  • Collaborate with R&D, marketing, engineering, and other departments to ensure alignment with project goals, as appropriate. Contribute to the compilation of FDA submissions as well as the compilation of documents needed for CE-marking.
  • Prepare data outputs for written and verbal presentations of study data for symposia, scientific presentations and exhibits, and FDA submissions, as appropriate.

POSITION QUALIFICATIONS:

  • Requires a minimum of a bachelor’s degree, Masters Preferred
  • Years and type of experience:
    • Significant (>7 years) industry experience, including clinical research, regulatory affairs, or clinical operations
    • Data management experience is required
    • Demonstrated understanding of anatomy, physiology, and medical terminology required. Medical background a plus
    • Strong statistics background a plus
  • Ability to effectively manage a study from start to finish
  • Demonstrated knowledge of FDA regulations, ICH-GCP guidelines and ISO 14155
  • Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items
  • Excellent decision-making skills
  • Excellent computer skills (MS Office and Outlook)
  • Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment
  • Ability to prioritize and manage multiple tasks

Apply for Clinical Research Project Manager