Electro Mechanical Assembler Gentuity - 4.0 Bedford, MA Job Details 19 hours ago Qualifications Manufacturing facility experience Medical device manufacturing facility experience Biomedical regulatory compliance Biomedical manufacturing processes

ISO 13485

Full Job Description Description:

Manufacture medical products (capital equipment) by following documented procedures and Manufacturing instructions. Perform equipment set-up and in-process testing to accomplish assigned task(s). Develop manufacturing processes and work with engineers to create written procedures. Support and train operators to manufacturing work instructions. Assist in problem solving activities for design, process, and testing. Assist in development and writing of test and measurement methods as needed. Support in design and fabrication of fixturing for test and assembly. Maintain accurate and legible manufacturing documentation. Clearly communicate ideas and findings to supervisor and colleagues. Other duties as required.

Requirements:

Minimum of three (3) years' experience in medical device development. Experience manufacturing medical device capital equipment. Knowledge of Quality Systems. Experience with Medical Device Regulation

ISO 13485.

Experience working in a startup environment a plus. Experience with electro-optics and opto-mechanical assemblies, laser and fiber optics components and processing a plus. Willing to learn new technical skills and gain engineering knowledge. Ability to handle small components and complex precision assemblies. Ability to manage multiple objectives in a fast-paced environment. Team player with good writing and communication skills. Candidates must be able to work from both our Bedford and Sudbury locations and be willing to travel between sites as needed.

EDUCATIONAL REQUIREMENTS

2-years technical degree or equivalent work experience.