Manufacturing Engineer I

Role: Support ophthalmic manufacturing process development, validation, and continuous improvement to ensure high-quality, compliant, and cost-effective production. Responsibilities: develop and optimize manufacturing methods, tooling, and equipment; support new product launches and sustaining engineering by providing manufacturability input; troubleshoot production issues; execute validation activities including protocols, equipment qualification, and risk assessments; design fixtures, tooling, and equipment in CAD and collaborate with suppliers. Requirements: Bachelor’s in Mechanical Engineering or related field; manufacturing experience in a regulated environment; familiarity with process development, equipment qualification, and validation; strong problem-solving, communication, and teamwork skills; proficiency in MS Office; CAD experience preferred. High-Value: ophthalmic device manufacturing, process development, validation/qualification, FDA, ISO 13485, cGMP; medical device industry experience preferred. Work Setup: based in Burlington, MA.