Job Description
Job Description
Job Title: R&D Systems Engineering Technician
Duration: 6+ Months (Possible extension)
Location: Waltham, MA 02452
Onsite Role
Responsibilities:
- Support the design, testing, and verification of innovative electrophysiology catheter systems.
- Will work closely with engineers to execute complex product testing, ensure robust documentation, and help bring cutting-edge technologies from concept to reality.
- Support the development, validation, and execution of test methods for product and system verification activities.
- Perform complex benchtop and system-level testing, including intricate physical setups involving catheter manipulation, fixture assembly, and precise alignment of electro-mechanical components.
- Operate computer-controlled test platforms, configure test parameters, execute semi-automated test sequences, and extract/analyze data using command-line scripts in Linux-based environments.
- Conduct product characterization and detailed analysis on new and incoming devices to verify quality, performance, and functionality.
- Maintain a well-organized laboratory environment, ensure equipment readiness, and strictly adhere to safety and quality protocols.
- Prepare clear, accurate, and detailed technical documentation and standardized test reports to effectively communicate results to engineering and cross-functional teams.
- Uphold the highest standards of patient safety and product quality by following the company’s Quality Policy, procedures, and all applicable regulatory requirements.
Education/Experience:
- High School Diploma (or equivalent) with 5+ years of relevant experience in medical device development or a highly regulated industry.
- Post-secondary education in a technical field (e.g., engineering technology, electronics, or mechatronics) is strongly preferred.
- Skilled at identifying, troubleshooting, and resolving technical issues using a structured and analytical approach.
- Ability to clearly document and present technical data.
- Hands-on experience with laboratory testing, instrumentation, and product verification in a regulated industry (medical device experience is highly preferred).
- Strong practical experience with electro-mechanical medical devices, including setup, operation, and troubleshooting of integrated hardware systems and precision assemblies.
- Experience interfacing with computer-based test systems and data acquisition tools, including Linux operating systems and command-line interfaces for data extraction and processing.
- Working knowledge of Good Laboratory Practices (GLP), validation protocols, and quality management systems.