System Engineer
4 days ago
DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.
RECRUITERS: DO NOT CONTACT.
About the Role:
We are seeking a talented and motivated Systems Engineer to join our R&D team. You will play a critical role in developing our advanced laser-based platform for intravascular lithotripsy (IVL). As a key contributor, you will work on various R&D and troubleshooting activities, define system requirements, develop measurement methods, establish pass criteria for tests, and characterize device performance.
Why Join Us?
- Be part of a pioneering team developing transformative medical device technologies.
- Engage in challenging, hands-on R&D work.
- Contribute to projects that have a real-world impact on patient outcomes.
Key Responsibilities:
Under limited supervision, and in accordance with all applicable federal, state and local laws and regulations and company procedures and guidelines, the responsibilities of the position include performing the following activities:
- Solve complex engineering challenges from the component to the system level.
- Translate customer needs into detailed system and subsystem specifications.
- Collaborate with hardware and software teams to ensure seamless integration.
- Verify that the system design meets all technical requirements.
- Support traceability efforts in documenting the coverage of requirements through testing.
- Conduct feasibility studies, R&D, V&V, and in vivo testing.
- Perform hands-on measurements, design engineering solutions, and generate high-quality internal reports and documentation.
- Develop and validate test methods and test setups.
- Serve as an R&D representative on cross-functional teams, supporting both product development and manufacturing processes.
- Manage sub-projects to optimize the product value for patients, physicians, and other stakeholders.
- Act as a liaison between external vendors and the team.
- Other duties assigned as needed.
Qualifications:
Education & Experience:
- Bachelor’s degree in Engineering or a related field (Master’s degree preferred).
- Must have at least three (3) years of experience in systems engineering or R&D.
- Must have experience in research and in documentation writing.
- Experience in product development and process transfer to manufacturing, working with cross-functional teams.
- Preferred experience in the medical device industry and knowledge of medical device standards (e.g. IEC 60601).
- Familiarity with design control processes, engineering change orders, CAPA, and software version control.
- Proficiency in MATLAB, Python, LabView, or Minitab is a plus.
- Experience with laser and optics, as well as signal or image processing, is an advantage.
- Experience with requirement management systems like DOORS, Requisite Pro, JIRA, or JAMA is an advantage.
Skills & Abilities:
- Strong problem-solving and analytical skills.
- Excellent communication skills, capable of explaining complex technical concepts in clear, simple terms.
- A collaborative team player.
- Self-driven, highly motivated, with a passion for learning new technologies.
Additional Requirements:
- Work travel on weekends may be required.
- Ability to lift up to 60 lbs occasionally.
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