The Manufacturing Engineer is responsible for developing, optimizing, and managing production processes to ensure efficiency, quality, and regulatory compliance. The Manufacturing Engineer works collaboratively to improve process reliability, reduce costs, and address manufacturing challenges to ensure uninterrupted production.
Essential Duties and Responsibilities
Develop and implement process control techniques and procedures to ensure consistent quality and compliance with regulatory standards.
Conduct process validation in accordance with FDA and ISO guidelines, including writing protocols, performing tests, and preparing reports.
Develop and maintain detailed documentation for manufacturing processes, including work instructions, process flow diagrams, and equipment maintenance schedules.
Provide technical support and training to manufacturing personnel to ensure a thorough understanding of processes and equipment.
Requirements
Bachelor's degree in mechanical engineering preferred or equivalent work experience required.
2-5 years' experience working as a Manufacturing Engineer or equivalent required; medical device industry experience a plus.
Work knowledge of medical device standards and regulations or an ability to develop a working knowledge of standards and regulations preferred.
Must possess strong verbal and written communication skills with the ability to communicate with colleagues of various cultures and personalities across internal and external teams.
Benefits
Meaningful work in a rapidly growing company with opportunity for advancement
Directly influence the quality of products and make a difference for patients worldwide
Opportunities for professional and personal growth
Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.
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