From our Z1 CPAP to iSleep to Nippy to Vivo, Breas Medical provides a full line of innovative respiratory medical devices to our patients. As we are embracing another stage of fast expansion, we are looking for a Production Technician to join our new facility at Billerica, MA. This position will be responsible for assembling electro-mechanical medical devices that are in compliance with applicable FDA, state, OSHA, and ISO regulations and standards. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced environment. Must have a positive attitude, be dependable, flexible, and mature.
Responsibilities:
• Follow applicable documentation and instructions to assemble electro-mechanical subassemblies and finished level products.
• Follow applicable documentation and instructions to test products or subassemblies for functionality or quality.
• Generate assembly records for system Device History Records (DHR).
• Troubleshoot problems with equipment, devices, or products.
• Maintain a neat and organized work area.
• Perform test protocols for product qualifications.
• Set up and operate production equipment in accordance with current good manufacturing practices (cGMP) and standard operating procedures.
• Separate scrap or waste materials for recycling, reuse, or environmentally sound disposal.
• Assist in material cycle counting activities as requested.
• Support engineering development activities as requested
Minimum Key Requirements:
• Requires a high school degree or equivalent with at least 3-5 years of experience in the field or in a related area.
• Excellent oral and written communication skills.
• Ability to use a variety of tools and equipment (hand tools, power supplies, meters, fixtures tooling).
• Familiarity with GMP environment; reading & checking Bills of Materials, schematics, and machine/assembly drawings.
• Ability to work under minimum supervision with a high degree of organizational and technical competence.
• Ability to function well under pressure and expend effort to meet
schedules and deadlines.
• Experiences in working in a medical device manufacturer preferred.
Able to drive for work if public transportation is not available
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