Sr Manufacturing Engineer

Quality Engineer

Support Medtronic's Surgical Innovations manufacturing operations in North Haven, CT by ensuring the highest standards of product quality and regulatory compliance. Develop, implement, and maintain quality standards, protocols, and procedures for manufacturing processes and finished medical device products. Partner closely with Manufacturing, Operations, and Engineering teams to improve process performance, enhance product reliability, and drive continuous improvement initiatives. Lead process validation activities, perform root cause investigations, manage CAPA and non-conforming material activities, conduct statistical analysis, and support inspection and testing strategies. Ensure documentation compliance and adherence to FDA, ISO, and internal quality management system requirements. Strong analytical, problem-solving, communication, validation, and quality systems expertise is essential.

Bachelor's Degree in Engineering, Science, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or related technical discipline. Typically 7+ years of experience in Engineering and/or Quality Engineering, preferably within medical device or regulated manufacturing environments. Strong expertise in process validation throughout the validation lifecycle. Experience with CAPA, NCMR, root cause investigations, and quality system requirements. Knowledge of statistical analysis tools (e.g., Minitab) and risk-based decision making. Experience with FDA, ISO 13485, and medical device regulatory requirements preferred.

LTTS is an Equal Opportunity Employer and maintains a clear policy against discrimination based on age, disability, sex, race, religion or belief, gender reassignment, marriage/civil partnership, pregnancy/maternity, or sexual orientation. As an inclusive organization, we actively endorse equal opportunities for all candidates with the right mix of talent, skills, and potential. We encourage applications from a diverse pool of candidates and selection for roles will solely be based on individual merit.

L&T Technology Services LTD is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require any accommodations to participate in the recruitment process or to perform the essential functions of the job, please let us know. We will work with you to provide reasonable accommodations in accordance with applicable law.