Location: Billerica, MA and Lowell, MA – 100% onsite, no remote
Salary ranges:
Billerica – 2-5 year candidate – Ideally $85k but up to 90k cap based on experience.
Lowell – 4+ yrs $90-130k + bonus
Perm Resident or US Citizen
Lead or work as part of cross-functional team in successful launches of medical devices and electromechanical equipment.
Manage and execute multiple projects simultaneously, overseeing program timelines and ensuring compliance with FDA, ISO, and quality standards, resulting in a track record of on-time deliveries of quality products.
Own continuous improvement initiatives, including design of tooling, providing design for manufacturing feedback, and maintaining technical documents such as drawings, runlists, bill of materials, and work instructions.
Conduct root cause analysis investigations to identify and resolve production issues, applying results to risk analysis to ensure product safety and improve overall quality.
Required
Billerica – 2-5 years of manufacturing engineering experience -preferably in an ISO 9001 or ISO 13485 environment
Lowell – 4+ year candidate for Lowell MUST have ISO 13485 or Medical Device Worked with Contract Manufacturers or OEM’s