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Senior/Principal Mechanical Engineer
ALung Technologies, Inc. develops breakthrough medical devices for respiratory support. We seek a Senior or Principal Mechanical Engineer to join our Research and Development team and participate in the design, pre-clinical, and clinical testing of our advanced respiratory support devices. You will be reporting to the VP R&D.
Responsibilities include:
- Lead mechanical engineering efforts (design and analysis) for the development of oxygenators and accessories (includes subassemblies, catheter)
- Provide guidance and support the development of the electromechanical driver
- Develop Verification and Validation protocols and follow through their completion
- Participate in establishing the supply chain and manage suppliers as necessary
- Develop documentation as required by the company’s QSR
Skills/Requirements:
- BS or advanced degree (preferred) in mechanical engineering.
- 5+ years product development experience (medical device industry preferred).
- Hands-on mechanical and electro-mechanical design experience of rotating mechanisms, pumps, polymeric and elastomeric components, and catheters.
- Experience in systems level design and analysis.
- Preferably possess CAD design skills (Solidworks).
- Working knowledge of geometric dimensioning and tolerancing.
- Must be able to communicate ideas and information clearly, effectively, and frequently (oral and/or written) within program team and throughout the company
- Background in fluid mechanics is preferred
- Possess a strong working knowledge of FDA's Quality System Regulation (QSR) and practical application through design control, SOP's, verification, and validation testing
- Familiarity with medical device standards and CE mark requirements for international use (including Shock/Vibration, Shipping/Transport, and Environmental requirements)
- Experience interfacing with external firms and suppliers (design and contract manufacturers)
Benefits:
ALung provides the best in medical insurance (HIGHMARK), Life insurance, Short and Long Term Disability insurance, AD&D insurance, Travel insurance, as well as a 401k Plan.
Contact Information:
Please e-mail resume to: bhengler@alung.com
Mailing Address: Bobbie Hengler
Human Resources Consultant
ALung Technologies, Inc.
333 E. Carson Street Suite 517A
Pittsburgh, PA 15219
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Clinical Coordinator
ALung Technologies, Inc. develops breakthrough medical devices for respiratory support. We seek a Clinical Coordinator to join our dynamic company to aid in developing our second-generation product. You will be responsible for planning, conducting, analyzing results, and writing reports for all clinical testing including: brain-dead human trials, terminal wean patient trials, safety trials and efficacy trials.
Responsibilities include:
- Manage clinical trials from study start-up to close-out to ensure compliance with regulatory issues, protocol requirements and Good Clinical Practice. The job requires a person with a clinical background that has experience with conducting and managing clinical trials.
- Plan clinical trials to meet company objectives
- Recruit principle investigators. Negotiate Investigator agreements
- Write clinical trial protocols
- Train investigators in clinical protocol including insertion, patient management, data collection and reporting
- Manage clinical sites. Serve as principal liaison between project team members, investigational sites, and the Principle Investigator
- Ensure the clinical data forms are properly completed and verify clinical data against source documents.
- Responsible for resolution of data queries.
- Prepare data summary for regulatory documentation
- Responsible for financial management of clinical trials
Skills/Requirements:
- A degree in a clinical field required…nursing or equivalent as one example
- At least 10 years relevant experience
- Experience conducting clinical trials a must
- Must have a working knowledge of clinical trials
- Must work well with regulatory staff, project team and investigators.
- Must have strong interpersonal skills
Benefits:
ALung provides the best in medical insurance (HIGHMARK), Life insurance, Short and Long Term Disability insurance, AD&D insurance, Travel insurance, as well as a 401k Plan.
Contact Information:
Please e-mail resume to: bhengler@alung.com
Mailing Address: Bobbie Hengler
Human Resources Consultant
ALung Technologies, Inc.
333 E. Carson Street Suite 517A
Pittsburgh, PA 15219
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