Engineer I Manufacturing

**ABOUT THE COMPANY**

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers’ devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you

**JOB SUMMARY**

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and medical device quality standards. This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

**ESSENTIAL RESPONSIBILITIES**
- Improves manufacturing processes, methods and controls for cost reduction, quality

improvements and efficiency for both sustained and new products.
- Prepares 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.
- Coordinates 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.
- Performs product and process analysis for cost reduction, quality improvement and improved

efficiency.
- Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
- Supporting 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.
- Complies with company, quality and safety standards, policies, and procedures
- Attends and schedules project meetings to determine current and future process initiatives.
- Support site documentation and manufacturing procedures.
- Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

**QUALIFICATIONS**
- A bachelor’s degree (Physics, materials, mechanical, electromechanical, mechatronic engineering discipline preferred) and 2 years of experience required; or a combination of education and relevant work experience.
- Knowledge of manufacturing and assembly processes
- Excellent verbal and written communication skills
- Fluency in English
- Prefer 2+ years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and

GMP principles preferred.
- Must be able to read blueprints and interpret technical specifications and illustrations.
- Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
- Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
- Experience associated with continuous improvement activities, including participations and/or

facilitating Kaizen events using lean manufacturing principles.
- The ability to understand a range of engineering functions and procedures.
- Interpersonal, presentation and communication skills.
- The capacity to work well under pressure and take on new challenges.
- Organizational and time management skills.
- Project management skills and the ability to work to tight deadlines

**WORKING ENVIRONMENT**

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this position.

**EEO STATEMENT