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Lungpacer Medical USA Inc. is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation and is seeking to hire an experienced and highly motivated QA Associate.

As a member of the Quality Team, the individual in this position is responsible for participating in activities related to operating and maintaining Lungpacer’s QMS. Responsible for the control of quality system documents, including document changes, document storage, and distribution of newly released documents. Support the Quality team in day-to-day activities. Other responsibilities as requested.

Responsibilities:

• Fulfill document change order (DCO) requests; release of documents and controlled distribution of copies to the intended locations, as required.
• Assign training to employees and follow up to ensure that training has been completed.
• Ensure employee training files are maintained and updated; update training matrix on regular basis; maintain training files for temporary and external employees, visitors, consultants, as needed.
• Ensure long-term storage of quality records is adequate in preventing any damage or deterioration and loss; ensure timely retrieval of records placed in long-term storage and disposition of records after the retention date has elapsed; ensure that the legibility of records is maintained; upon request, provide quality records to internal or external parties for review.
• Review records to evaluate compliance to instructions and QMS processes.
• Maintain supplier files and associated records and participate in supplier QMS audits.
• Conduct internal audits of Lungpacer’s quality management system to identify and evaluate gaps in the QMS that may pose a risk to the business.
• Support the Quality team during external audits of the company’s quality management system.
• QC Inspection of incoming product and manufactured product as required.

Qualifications & Required Skills:

• Bachelor’s Degree or Technical Diploma in a technical field, or an equivalent combination of education, technical training, and/or related experience.
• A minimum of 2 years of Quality Assurance experience in the medical device industry.
• Working knowledge of regulatory requirements (e.g., ISO 13485:2016, cGMP, etc.) is required.
• Attention to detail, initiative, self-motivation, planning and organizational skills.
• General understanding of office procedures including filing systems and records management is required, as well as: Ability to use MS Word, Excel, and Adobe Acrobat.
• Excellent communication skills and strong analytical and problem-solving skills.
• Ability to work autonomously as well as collaborate daily in a cross-functional setting.
• Flexible and adaptable to take on additional responsibilities as appropriate.

The primary location of work will be at our facility in Exton, PA, the position may require some travel. 

We are not offering visa sponsorship or relocation for this role at this time.

We are not using agencies for this role at this time.

We thank all interested applicants. However, only those under consideration will be contacted. No Phone Calls, please.

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

Lungpacer Medical USA, Inc. is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation and is seeking to hire an experienced and highly motivated Senior Mechanical Engineer to be based at our Exton, PA location.

As a member of the Mechanical Engineering Team, the position is responsible for providing design and technical expertise in the area of assigned development activities. Other responsibilities as requested.

Responsibilities

• Demonstrate knowledge of engineering principles and its application in solving complex problems.
• Demonstrate working knowledge of product enhancements and manufacturing process refinement.
• Use analysis tools and methods to solve complex technical problems (e.g. CAD, FEA. CFD)
• Generate design concepts and prototypes using specialized hand tools to test their mechanical and electrical properties.
• Assist in the transfer of R&D prototypes builds to manufacturing by developing repeatable and accurate processes.
• Develop and assist in the design of fixtures and tooling used in fabrication and testing of prototypes.
• Generate CAD models and technical drawing files for fabrication in accordance with company drafting standards as applicable.
• Develop design verification test methods and test fixtures.
• Lead individual design verification test methods, including writing test protocols, overseeing test progress, providing direct input in test activities and preparing test reports at completion.
• Pre-clinical testing, data collection and analysis of prototype catheters.
• Support activities to enhance IP portfolio of the company.
• Collaborate with outside vendors to obtain quotes, technical information, and purchase materials/supplies and equipment/tooling.
• Technical writing and presentations.
• Create and oversee the preparation of mechanical engineering designs, drawings, specifications, schedules, and cost estimates.
• Provide technical assistance to other mechanical engineers and resolve technical issues.
• Create validation documentation (IQ, OQ & PQ) and lead the execution of process qualifications for new and existing processes.

Qualifications

• Bachelor’s in Mechanical/Biomedical Engineering or related field
• 8+ years of medical device industry or related experience OR Master’s Degree in Engineering and 6+ years related experience.
• Demonstrated SolidWorks experience or other CAD software tools.
• Excellent organizational, analytical reasoning, problem-solving, and conflict management 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.
• Ability to handle confidential and sensitive material with discretion.
• Knowledge of medical device regulations and standards

Additional Notes:

• This role is expected to work independently and with minimal supervision, under the direction and support of management.
• This role may involve supervision and management of Interns and other junior staff.
• Regular office work and R&D Lab environment. PPE and/or cleanroom gowning may be required, if entering the laboratories and/or cleanroom.