Design and develop innovative pulmonary interventional devices, including disposable and implantable catheter-based systems, to treat patients with severe COPD and emphysema, applying advanced engineering principles.
Serve as the lead engineer, providing project support from design, prototyping, and testing to manufacturing transfer and clinical use.
Develop and execute test protocols/reports, design test fixtures, perform testing, and document results.
Design 3D part models and assemblies for machining and injection molding processes.
Design and develop products in compliance with the company's Design Control requirements.
Translate clinical and user needs into design requirements.
Provide sustaining engineering support for existing Pulmonx product lines.
Lead or actively participate in multidisciplinary project teams to ensure projects are completed on time, within scope, and in compliance with quality standards.
Collaborate with vendors to support product design and manufacturing needs.
Maintain detailed documentation throughout all product development phases, including test protocols, reports, engineering drawings, manufacturing procedures, and work instructions.
Coordinate out-source testing activities as required.
Participate in animal studies as needed.
Contribute new product ideas and innovations to the company's intellectual property portfolio.
Self-directed, capable of meeting project goals with moderate supervision.
Proactively identify, communicate, and resolve issues, effectively mitigating risks.
Up to 5-10% Domestic and International Travel.
Qualifications:
5+ years of experience in engineering product design, with 3+ years in the medical device industry.
BS or MS in Mechanical or Biomedical Engineering.
Proven track record of successful product development, from concept through product launch.
Strong understanding of engineering principles, materials, component selection, and design for reliability and manufacturability.
Proficient in 3D CAD modeling, i.e. Solid Works, and Geometric Dimensioning & Tolerancing (GD&T) and drawing standards.
Familiarity with statistical analysis.
Experience with catheter-based NiTi medical devices is a plus.
Understanding of regulatory and quality systems requirements for medical devices (FDA, QSR, ISO, CE mark).
Familiarity with testing requirements for medical devices, including biocompatibility, sterilization, shelf-life testing, etc.
Ability to effectively manage multiple projects and tasks, both independently and within cross-functional teams.
Strong written, verbal, and interpersonal communication skills.
Self-Starting, detail oriented, quick learner, creative and analytical.
Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, scanners, printers, and filing cabinets.
Physical Demands: This is largely a sedentary role; however, some physical activity is occasionally required. Will occasionally work in the lab/cleanroom. Traveling and supporting clinical cases will require extended durations of walking and standing.
Please note that an application and resume must be completed and submitted for consideration for this opportunity.
Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.
