ABOUT THE COMPANY

More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec 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 Title:

Engineer I, Manufacturing

Location:

Sturtevant, WI

Department/Group:

Operations

Position/Classification Type:

Exempt

Reports To:

Engineering Manager

Direct Reports:

None

Shift:

1st

JOB SUMMARY:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III 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.
• Attends and schedules project meetings to determine current and future process initiatives.
• Complies with company, quality and safety standards, policies, and procedures
• Other duties as assigned.

QUALIFICATIONS:

• A bachelor’s degree in engineering with 0 years of experience; or a combination of education and relevant work experience.
• Knowledge of manufacturing and assembly processes.
• Excellent verbal and written communication skills.
• Prefer 2+ years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
• 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.
• Must be able to read, write and speak fluent English.
• 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.

WHAT WE OFFER:

• Ability to work on cutting edge lifesaving products
• 401(k) retirement savings with a company match
• Training and career development
• Tuition assistance
• Health care and well-being programs including medical, dental, and vision
• Paid time off
• Sign-on and referral bonuses
• Employee appreciation events
• Employee recognition program
• Clean and well-lit production areas

WORKING ENVIROMENT:

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.

All employees will be provided with training in working safely, evacuation procedures, accident reporting and other safety topics the company feels are necessary to ensure and maintain a safe work environment from hazards to the employee.
An employee who does not feel safe or recognizes an unsafe practice, should report it immediately to their supervisor as a recognized responsibility of the position.

EEO STATEMENT:

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.