Working at Lungpacer

Lungpacer is developing a novel therapeutic solution for preserving or restoring the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation.

At Lungpacer, we succeed together, that’s why we’re committed to fostering and rewarding innovation, passion, collaboration and courage amongst our employees. We maintain a team-oriented work environment where individuals’ capacities and accomplishments are recognized, and their career development nurtured. We hire only the best individuals who are highly motivated and strong team players and we trust them to make the right decisions to achieve our goals. We also believe in having fun while working hard.

We offer a collaborative work environment, a comprehensive salary and benefits program, and the ability to participate in equity through a stock option plan.

Job Openings

Senior Electrical Engineer

Descriptions

Lungpacer Medical USA Inc., a subsidiary of Lungpacer Medical Inc. – a British Columbia Corporation, is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation, is seeking to hire experienced and highly motivated Senior Electrical Engineer.
As a member of the Hardware Engineering Team, the position is responsible for providing design and technical expertise in area of assigned development activities.
A PDF version of this job description can be accessed here: Senior Electrical Engineer_2019.03.04

Job Responsibilities
• Lead establishment of design requirements from VOC and translate into objective, testable lower level engineering requirements. • Lead internal and/or external design activities to support development of new technologies and complete functional systems including manufacturing processes. • Prepare schematics, simulations, prototypes, PCB layouts, specifications, bills of materials, assembly drawings, and other documents as required to manufacture or support product. • Lead, develop, implement characterization and/or design verification strategies for existing and new designs. • Prepare and/or review design change requests including V&V activities supporting design changes. • Perform analysis of designs for risk, hazard, test, assembly, manufacturability, etc. • Contribute to the IP landscape via invention disclosures, disclosure expansion, and patent filings. • Support Manufacturing and root cause analysis of product failures as required. • Adhere to Lungpacer’s QMS including design control policies to ensure product quality. • Perform technical writing and develop/deliver presentations as required.
Qualification
• Bachelor’s in Electrical Engineering or related field. • 7+ years of related experience OR Master’s degree in Engineering and 5+ years related experience. • Demonstrated experience in both analog and digital electronic design/development that includes use of microcontrollers. Embedded software experience a plus. • Ability to create limited SW applications (e.g., Lab View) a plus. • Ability to design and implement FPGA logic in VHDL is preferred. • Demonstrated experience with design test creation and execution. EMC / EMI compliance testing experience a plus. • Familiarization with and practical knowledge of simulation tools. • Strong knowledge of FDA Design Controls / ISO13485 / EU MDR and medical device product development is preferred. • Familiarization with IEC60601, IEC62304, and ISO14971 is preferred. • Strong knowledge and demonstrated successes in the development of complete medical systems including electronics and software is preferred. • Must be able to weigh, document, articulate the strategic and tactical alternatives that deliver complete, reliable, and safe systems that meet customer needs. • Excellent interpersonal and communication (both oral and written) skills.
Notes
The primary location of work will be at our facility in Exton, PA. The position may require some travel. Qualified candidates may send a letter of interest and resumé to hr@lungpacer.com. Please quote Senior Electrical Engineer in your e-mail subject box. We thank all interested applicants. However, only those under consideration will be contacted. No Phone Calls, please.
Apply

Senior Software Engineer

Descriptions

Lungpacer Medical USA Inc., a subsidiary of Lungpacer Medical Inc. – a British Columbia Corporation, is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation, is seeking to hire experienced and highly motivated Senior Software Engineer.
As a member of the Software Team, this senior position is responsible for providing design and technical expertise in area of assigned development activities.
A PDF version of this job description can be accessed here: Senior Software Engineer_2019.03.04

Job Responsibilities
• Generate design concepts & prototypes, test their performance in simulated and real-world conditions. • Use analysis tools and methods to solve complex technical problems. • Participate in the definition and analysis of software requirements and risk analysis activities. • Demonstrate working knowledge of product enhancements and algorithm refinement. • Prepare and/or review design change requests including Verification & Validation activities supporting design changes. • Participate in pre-clinical testing, data collection and analysis of prototype hardware. • Participate in maintenance of IEC 62304 processes. • Support Manufacturing as required. • Support activities to enhance IP portfolio of the company. • Adhere to Lungpacer’s QMS including design control policies to ensure product quality. • Perform technical writing and develop/deliver presentations as required.
Qualification
• Bachelor’s in Software Engineering or related field. • 8+ years of direct experience developing embedded software. Experience in medical device development is preferred. • Proficiency in C and C++. • Experience with object-oriented analysis and design techniques. • Experience with embedded real-time operating systems, such as SafeRTOS. • Experience in FPGA VHDL logic design and implementation is preferred. • Familiarization with IEC60601, IEC62304, and ISO14971 is preferred. • Excellent organizational, analytical reasoning, problem-solving, and conflict management skills. • Experience with Agile Software Development processes is preferred. Familiarization with Jira is a plus. • Must be able to weigh, document, articulate the strategic and tactical alternatives that deliver complete, reliable, and safe systems that meet customer needs. • Excellent interpersonal and communication (both oral and written) skills. • Ability to handle confidential and sensitive material with discretion.
Notes
The primary location of work will be at our facility in Exton, PA. The position may require some travel. Qualified candidates may send a letter of interest and resumé to hr@lungpacer.com. Please quote Senior Software Engineer in your e-mail subject box. We thank all interested applicants. However, only those under consideration will be contacted. No Phone Calls, please.
Apply

Software V&V Engineer

Descriptions

Lungpacer Medical USA Inc., a subsidiary of Lungpacer Medical Inc. – a British Columbia Corporation, is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation, is seeking to hire experienced and highly motivated Software V&V Engineer.
As a member of the Software Engineering Team, the individual in this position is responsible for providing technical expertise and knowledge in software validation and verification activities. Other responsibilities as requested.
A PDF version of this job description can be accessed here: Software V&V Engineer_2019.03.04

Job Responsibilities
• Design, implement, debug, and execute unit tests (white box) for complex software being developed • Develop unit tests using automated software unit testing tools • Develop and maintain system level (black box) software and hardware integration tests • Design and develop test methods for software verification • Engage in software development activities including coding and code reviews • Participate in pre-clinical testing, data collection and analysis of prototype software • Document test results including logging issues and proposing solutions • Validate off-the-shelf software tools • Create, review, and manage requirements and traceability matrices • Participate in risk analysis activities as they relate to software • Lead in the maintenance of IEC 62304 (full software development lifecycle) processes. • Review software development process for consistency with Lungpacer SOPs and development plans • Review design changes for impact on verification & validation activities. • Work closely with other departments to build test tools for verification and validation activities • Adhere to Lungpacer’s QMS including design control policies to ensure product quality • Support activities to enhance IP portfolio of the company
Qualification
• Bachelor’s in Software Engineering or related field • 5+ years of direct experience in software V&V • Programming Experience in C and C++ • Experience testing embedded applications using unit testing • Experience with automated software unit testing tools (VectorCAST preferred) • Familiarization with IEC62304, ISO13485, and ISO14971 is preferred. • Strong technical documentation skills • Excellent organizational, analytical reasoning, and problem-solving skills. • Experience with Agile Software Development processes is preferred • Excellent interpersonal and communication (both oral and written) skills • Ability to handle confidential and sensitive material with discretion
Notes
The primary location of work will be at our facility in Exton, PA. The position may require some travel. Qualified candidates may send a letter of interest and resumé to hr@lungpacer.com. Please quote Software V&V Engineer in your e-mail subject box. We thank all interested applicants. However, only those under consideration will be contacted. No Phone Calls, please.
Apply

Technical Field Engineer

Descriptions

Lungpacer Medical USA Inc., a subsidiary of Lungpacer Medical Inc. – a British Columbia Corporation, is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation, is seeking to hire a highly motivated Technical Field Engineer.

As a member of the Operations Team, the individual in this position is responsible for providing Clinical Affairs Specialist and Investigational Centers product support in the field to ensure safe and effective product use that optimizes patient care.

A PDF version of this job description can be accessed here:Technical Field Engineer_2019.09

Job Responsibilities
• Deliver employee and healthcare provider product support in the field to support clinical trial cases. • Facilitate technical problem solving related to the product and therapy with clinical affairs specialists and healthcare providers to optimize patient care. • Document case study reports. • Assist with answering questions from Clinical Research Coordinators, Investigators, Sales Personnel, and other staff members regarding investigational released study devices. • Assist with identification of logistical and operational issues that arise during study execution and communicate these in a timely fashion to management. • Provide feedback to product development, training and marketing teams regarding product performance. • Partner with key personnel to identify areas of clinical performance improvement that will reduce cost and support clinical areas with an opportunity to improve outcomes. • Develop performance improvement strategies; lead process improvement initiatives. • Install, operate, repair equipment. • Perform preventive maintenance in the field. • Perform field upgrades, if needed. • Support future product integrations by performing upgrades to equipment.
Qualification
• Bachelor’s in Electrical Engineering or related field • 3+ years of related experience OR Master’s Degree in Engineering and 1+ years related experience. • Excellent organizational, analytical reasoning and problem-solving skills. • Ability to successfully navigate complex environments and relationships. • Excellent interpersonal and communication (both oral and written) skills. • Skilled in the use of word processing, database, spreadsheet, image editing, and desktop publishing software, as well as web searching techniques. • Knowledgeable of ICH and GCP guidelines. • Ability to handle confidential and sensitive material with discretion.
Notes
The primary location of work will be at clinical sites across the US (approximately 80%) and the position will work from our Exton, PA office when not traveling. Qualified candidates may send a letter of interest and resumé to hr@lungpacer.com by September 30, 2019. Please quote Technical Field Engineer in your e-mail subject box. We thank all interested applicants. However, only those under consideration will be contacted. No Phone Calls, please.
Apply

Clinical Data Manager

Descriptions

Lungpacer Medical USA Inc., a subsidiary of Lungpacer Medical Inc. – a British Columbia Corporation, is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation, is seeking to hire experienced and highly motivated contract Clinical Data Manager.
As a member of the Clinical Team, the individual in this position is responsible for providing oversight regarding all aspects of data management duties.

A PDF version of this job description can be accessed here: Clinical Data Manager_2019.09

Job Responsibilities
• Direct oversight of all EDC design build and sponsor User Acceptance Testing (UAT) processes conducted by the CRO. • Lead the efforts in establishing a Data Management Plan. • Oversee the CRO regarding case report form (CRF) design, data edit checks and aggregate check specifications. • Assist with all aspects of Soft and Hard Database Locks & Analysis, including coordination with the study PM, statistician and CRAs. • Serve as the primary Sponsor contact person for day to day data management activities, as well as, the primary contact person for communication and discussion of topics related to data management timelines and deliverables. • Provide database and data management activities status reports; contribute to the overall project planning, progress tracking and reporting. • Conduct training on electronic data capture (EDC) system, dataflow and quality control processes to internal clinical trial personnel, as needed. • Assist in the review of Data Management related scope of work, work orders and amendments. • Prepare data status slides for senior management as needed for board or investigator meetings. • Participate in study meetings as applicable (i.e., project kick off meeting, investigators meeting, and regular project management team meetings). • Provide support to internal audits and regulatory inspections, regarding Data Management duties. • Manage the process of database modifications, due to protocol amendments or study needs with the CRO. • Review the CRO Data Quality Review Plan (DQRP). Coordinate with CRO programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP. • Review data, issue and resolve queries, as well as assist CRAs with resolving queries, as needed. Manage and coordinate data activities for all clinical trials to deliver data for analysis and submission as part of a regulatory filing. • Provide listings as needed in preparation for Safety Committee Meetings. • Proactively work with the CRO to organize on-going data review throughout the study to ensure timely identification and correction of errors or discrepancies. • Oversee CRO regarding final data management documentation archival activities.
Qualification
• A Bachelors’ or Advanced degree in health sciences, physical/biological, or chemistry fields. • At least 7 years of experience in Medical Device clinical trial data management with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction • Knowledge of industry and regulatory standards (CDISC, SDTM) with an ability to translate clinical team objectives into operational actions. • In-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as medical device clinical trial regulations, industry guidance, conventions and standards. • Strong leadership in clinical data management activities and a desire to excel in leading data management projects. • Strong communication skills and ability to work efficiently with a variety of people.
Notes
The primary location of work will be at our facility in Exton, PA. The position may require some travel. Qualified candidates may send a letter of interest and resumé to hr@lungpacer.com by September 30, 2019. Please quote Clinical Data Manager in your e-mail subject box. We thank all interested applicants. However, only those under consideration will be contacted. No Phone Calls, please.
Apply
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Corporate Headquarters

Lungpacer Medical Inc.
Suite 130, 601 W Cordova Street
Vancouver, B.C. V6B 1G1
Canada

USA

Lungpacer Medical USA Inc.
260 Sierra Drive, #116
Exton, PA 19341
USA

Caution: Investigational Device
The Lungpacer Diaphragm Pacing Therapy System is limited by Federal (United States) law to investigational use.The device is not approved for sale in the United States or Europe. Lungpacer®, Weaning Solution®, Lungpacer DPT System™, Lungpacer DPT™, LIVE Catheter® are registered trademarks of Lungpacer Medical.