DescriptionPosition Summary: We are actively looking for a Manufacturing Engineer II 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 II, you will be primarily responsible for new product introduction. You will be working directly with design engineers to mature the process and ensure new lines are ready for transfer. You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective. Manufacturing Engineers document processes implement ideas and solutions to improve assembly, operations, and reduce costs develop tooling/fixturing drive investigations tied to non-conformances.
Key Responsibilities:- Develops and implements robust cost-effective manufacturing processes and improves product flow and product quality and safety performance for both sustained and new products.
- Leads design transfer of new products to production; including establishing assembly time and yield targets, training needs, and quality control.
- Develops tests, implements tools fixtures, and equipment required for manufacturing processes.
- Develops manufacturing process instructions inspection plans and lot history travelers
- Leads creation of manufacturing process validation, plans validation protocols, and reports and implements manufacturing process validations and test method validations.
- Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).
- Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks and implement preventive and corrective actions.
- Manages and/or supports production and test equipment maintenance qualification and calibration.
- Performs analysis for cost reduction, quality, and efficiency improvement.
- Prepares engineering change orders (ECOs) and coordinates the implementation of changes including training production staff.
- Troubleshoots designs and processes when defects occur leads investigation to determine root cause and implements effective containment and counter measures.
- Dispositions non-conforming products and develops required re-work procedures.
- Communicates with customers regarding process improvements and production changes.
Must Have:- BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering (STEM) discipline required.
- 2+ years of experience in medical device process development and/or manufacturing engineering.
- Experience with new product introduction (NPI).
- Solid knowledge of GMP and ISO 13485 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: $98,000-$120,000 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.
