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
- Collaborate with development engineers to ensure manufacturability of new product designs and the cost-effective integration into production.
- Improve medical device manufacturing processes, develop and integrate tools, to enhance production efficiency and product quality.
- Develop and implement process control techniques and procedures to ensure consistent quality and compliance with regulatory standards.
- Collaborate internally or with suppliers to develop or procure appropriate equipment and tools necessary for manufacturing processes.
- Troubleshoot and resolve manufacturing issues, applying root cause analysis and implementing corrective and preventive actions.
- 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.
- Performs all other duties and responsibilities assigned.
- 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.
- Extensive knowledge of production principles and techniques.
- Possess an analytical mindset, strong attention to detail and be able to work independently.
Physical Requirements
This position requires 5 or more hours per day sitting and talking/listening, 0-2 hours per day standing, walking, reaching, and bending. Lifting 25 pounds 0-2 hours per day. Moderate office noise. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 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.
