Seeking a detail-oriented and technically skilled R&D Technician to support the R&D and Engineering team in the development of cutting-edge medical devices. This role involves the setup, calibration, maintenance, and repair of specialized lab and test equipment, as well as supporting engineering teams during prototyping, testing, and validation phases. The ideal candidate will have hands-on experience with electromechanical systems, a strong understanding of safety and quality standards, and the ability to work in a fast-paced, regulated environment.

Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Machine, build, assemble and test performance of engineering prototypes, design iterations, DVT & clinical builds to support clinical trials, and eventual transfer to manufacturing.
• Support the assembly and modification of prototype/investigational devices and test fixtures, using basic machine shop tools, soldering, and mechanical/electronics rework when necessary.
• Assist engineers and scientists in the preparation and execution of tests.
• Set up, calibrate, troubleshoot, and maintain laboratory and test equipment used in medical device R&D, including mechanical testers, environmental chambers, microscopes, and data acquisition systems.
• Document equipment maintenance and calibration activities in accordance with internal procedures and regulatory standards.
• Monitor inventory and procure supplies, tools, and parts needed for equipment maintenance and test setups.
• Participate in equipment validation and qualification activities (IQ/OQ/PQ).
• Ensure all activities comply with workplace safety policies and industry regulations.
• Collaborate with cross-functional teams including design, quality, and manufacturing engineering.
• Adhere to Clients Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Work collaboratively with QA in developing, evaluating/testing, documenting, improving and implementing manufacturing processes/methods, tooling and fixtures; support product development transitioning from investigational device to manufacturing production; support manufacturing and process optimization.
• Document device performance observations and results in Company’s issued notebook.
• Support the transfer of product lines and the qualification-validation efforts.
• Perform other work-related duties as assigned

Minimum Qualifications (Knowledge, Skills and Abilities)

• Associate degree or technical diploma in Engineering Technology, Electronics, Mechanical Technology or a related field.
• Minimum of 10 years of capital equipment experience in the medical device industry
• Strong hands-on skills with mechanical, electronics and electrical systems. Prior experience in optics or fiber-optics a plus.
• Basic proficiency with Solidworks and 3D printing; basic programming knowledge a plus.
• Proficiency with basic tools (e.g. crimping tool, wire stripper, etc.), measurement equipment (e.g. calipers, micrometers, force gauge, etc.), and diagnostic instruments (e.g. oscilloscopes, multimeters, power meter, etc.).
• Familiarity with FDA CFR, ISO 13485 and GMP standards
• Understanding of cleanroom practices and ESD safety.
• Self-motivated, independent and collaborative as a member of a multidisciplinary team; the ability and willingness to work in a fast-paced environment with multiple priorities and meeting development schedule without close supervision.
• Strong attention to detail and organizational skills with excellent problem-solving abilities and a proactive mindset.
• Clear written and verbal communication skills.