DescriptionPosition Summary: We are actively looking for a Manufacturing Engineer I who can bring innovation and creative thinking to the team on catheter-based devices in a fast-paced medical contract manufacturing space. As a Manufacturing Engineer I, you will be primarily responsible for new product introduction. You will be working to mature the process to ensure new lines are ready for transfer, along with developing and implementing robust, cost effective manufacturing processes and methods. You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective. Manufacturing Engineers document processes and implement ideas and solutions to improve assembly, operations, and reduce costs, develop tooling/fixturing, and drive investigations tied to non-conformances.
Key Responsibilities:- Improve manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
- Prepare engineering change orders and coordinates the deployment of changes including training operation team members.
- Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
- Coordinate the manufacturing launch of new products including establishing yield targets, run rates, training needs, and evaluating results.
- Develop and qualify various tools and equipment required for manufacturing processes.
- Perform product and process analysis for cost reduction, quality improvement and improved efficiency.
- Utilize tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
- Support required equipment qualification and process validations (IQ, OQ and PQ).
- Troubleshoot manufacturing processes when defects occur. Determine root cause and implement effective containment and countermeasures.
- Disposition non-conforming products and develop re-work procedures.
- Communicate with customers regarding process improvements and production changes.
- Represent manufacturing on cross functional teams.
- Participate in Kaizen events and drive continuous improvement efforts.
- Attend and schedule project meetings to determine current and future process initiatives.
Must Have:- BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering (STEM) discipline required.
- Knowledge of manufacturing and assembly processes.
- Prefer 2+ years of experience in medical device process development and/or manufacturing engineering with Class II or Class II medical devices.
- Experience with new product introduction (NPI).
- Solid knowledge of GMP and ISO/FDA regulations.
- Must be able to review and interpret technical drawings and specifications.
- Strong computer skills including the MS Office suite.
- Must be able to read, write, and speak fluent English and must possess excellent communication skills, both written and oral.
- Must have demonstrated organizational skills to manage multiple priorities and schedules.
Good to have:- Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.
- Proficiency in SolidWorks.
- Experience working directly with catheters.
Salary Range: $85,000 - $105,000 based on skills and experience.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
