Job Description
Are you ready to make a tangible impact on human health? PulseMed Innovations is seeking a highly skilled and innovative Senior Medical Device Engineer to lead the next generation of life-saving technologies.
Based in the heart of San Francisco, you will work in a collaborative environment dedicated to pushing the boundaries of medical science. You will oversee the entire product lifecycle, from concept to compliance, ensuring our devices meet the highest standards of safety and efficacy.
If you are a problem solver with a passion for engineering excellence, we want to hear from you.
Responsibilities
- Design and develop complex electromechanical systems for next-generation medical devices using advanced CAD tools.
- Lead cross-functional teams in R&D to ensure seamless integration of hardware and software components.
- Conduct rigorous testing and validation protocols to ensure product reliability and regulatory compliance.
- Manage the entire product development lifecycle, including prototyping, manufacturing documentation, and troubleshooting.
- Collaborate with regulatory affairs to prepare submissions for FDA approval and maintain ISO 13485 certification.
- Provide technical mentorship to junior engineers and drive continuous improvement initiatives within the department.
Qualifications
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- Minimum of 7 years of experience in medical device design and development.
- Proven track record of successfully bringing products through the FDA approval process.
- Expert knowledge of medical device standards (IEC 60601, ISO 13485) and quality management systems.
- Proficiency in engineering simulation software (e.g., COMSOL, ANSYS) and CAD (SolidWorks, Pro/E).
- Strong analytical skills with the ability to troubleshoot complex engineering problems.