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

Senior Clinical Operations 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 Senior Clinical Operations Manager.
As a member of the Clinical Compliance Team, the individual in this position is responsible for providing operational support for clinical related activities, under direction of Lungpacer Medical’s Director of Clinical Compliance. The role includes the development and implementation of clinical research projects, creation and management of study timelines, budgets, reports and communication materials, assistance with oversight of Clinical Research Organizations (CROs) and other vendors, and the preparation, review and approval of various study related documents and plans.
A PDF version of this job description can be accessed here: Senior Clinical Operations Manager_2019.03.04

Job Responsibilities
• Support the Director of Clinical Compliance in assisting the Clinical team execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines. • Develop and maintain clinical timelines using Microsoft Project. • Manage and maintain the Project team tracker. Prepare and maintain project organograms. • Assist with the development and maintenance of the project and risk management plans. • Manage the overall study budget, track invoices and facilitate clinical study and vendor (CRO and CRA) payments. • Assist with execution of clinical studies including the management, of vendors including CROs, review of work orders and review of invoices. • Interface with Clinical Affairs staff to ensure engagement and coordination of activities for clinical studies. • Proactively identify areas of risk and contribute to the risk management plan. • Monitor and track progress of clinical study activities. Assis the Director of Clinical Compliance in preparing reports on the progress of assigned clinical trials including enrollment, budget and timelines. • Track and forward regulatory documents to the CRO for the clinical Trial Master File. • Review study-related plans generated by CROs and vendors to ensure documentation is in accordance with GCP regulatory requirements and consistent with the protocol. • As needed, contribute to the writing and review of clinical documents including the protocol, consent form, investigator brochures, monitoring plan, clinical trial reports and annual IRB/EC reports. • Support the Clinical team with start-up activities including but not limited to investigational site contracts, investigational site and ethics committee/IRB submissions (working collaboratively with clinical site managers and external resources such as legal counsel). • Provide support to the VP of Regulatory Affairs for regulatory submissions, filings and strategy, including regulatory reporting of safety events to appropriate regulatory authorities. • Provide support to the Quality department during audits and corrective action resolution and reporting (CAPA) related to clinical trials activities. • Prepare clinical documents for DCO and route them through to final execution. • Assist the Clinical Affairs team in the planning and conduct of Investigator Meetings, Study Coordinator meetings, etc. • Assist the Director of Clinical Compliance in the drafting and preparation of new department SOPs, review, and training of the clinical team, CRAs and CRO. Prepare process flowcharts as needed. • Support the preparation of Clinical related information for Board of Directors and other stakeholders under the direction of the Director of Clinical Compliance.
Qualification
• Bachelor’s degree is required. Scientific/health care background preferred, but not required. • Minimum of 7 years in in clinical trial research and project management. • Thorough working knowledge of FDA and ICH GCP guidelines. • Experience managing CROs, budgets, and timelines. • Strong verbal and written communication skills. • Ability to organize and manage multiple priorities in a fast-paced environment. • Ability to work independently. • Strong interpersonal skills to interact with investigators, vendors, CRO, field and in-house individuals at all levels of the organization.
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 March 25, 2019. Please quote Senior Clinical Operations 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.