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Sr Engineer Manufacturing
4 months ago
This position is eligible for a $5,000 Sign-On Bonus
WHO WE ARE:
For over three decades, Cirtec has been an industry-leading outsource partner for complex medical devices. Cirtec Medical provides outsourcing solutions for Class II and III medical devices. From design and development, to precision components and finished device assembly, Cirtec can help bring complex devices to market. Cirtec's expertise includes neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
OUR PEOPLE:
The key to our success is our employees. The extensive design, development and manufacturing experience they provide enables us to create cost-effective, innovative medical device solutions for our customers. Our creative and innovative staff are expert problem solvers and understand the technical, practical and regulatory issues involved in bringing a new or next-generation product to market.
WHY WORK FOR CIRTEC:
With three locations in Brooklyn Park, MN, our employees have the satisfaction of knowing that the work they do helps patients live better, longer lives and their commitment and expertise have made the company it is today: An industry leading provider of life enhancing therapies.
JOB SUMMARY:
This position is primarily responsible for maintaining, developing, and implementing robust cost-effective
manufacturing processes and methods in accordance with customer product specifications for
components and assemblies to Class III medical device quality standards. Manufacturing Engineers
document processes and could implement creative ideas or solutions to improve assembly operations
which may include development of tooling/fixturing as needed to accomplish this task.
ESSENTIAL RESPONSIBILITIES:
• Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements and efficiency from conception to fully established production.
• Improve manufacturing process instructions, product flow, assembly methods, space allocation,
product quality and safety performance.
• Help product development with the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results.
• Prepare engineering change orders and coordinates the deployment of changes including training Operations team members.
• Perform product and process analysis for cost reduction, quality improvement and improved
efficiency.
• Utilize tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks
and the associated corrective actions.
• Support required equipment installation qualifications, process validations, and retroactive legacy
qualifications or validations.
• Troubleshoot processes when defects occur. Help to determine root cause and implement effective containment and countermeasures.
• Active participant in Material Review Board (MRB). Help to lead Non-Conforming Material Report
(NCMR) or customer complaint investigations.
• Develop, test, and provide ROI cost justification for various tools or equipment recommended for
manufacturing.
• Disposition non-conforming products and develop re-work procedures.
• Communicate with customers regarding process improvements and requested production changes.
• Represent manufacturing on cross functional teams.
• Participate in Kaizens and drive improvement efforts.
• Attends, schedules, and leads project meetings to evaluate current and future process initiatives.
• Complies with company, quality, and safety standards, policies, and procedures.
• Other duties as assigned.
WHAT YOU WOULD BRING:
• A Bachelor’s degree (STEM engineering discipline preferred) and 5 years of experience required;
or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing
processes (medical device preferred).
• Advanced knowledge of manufacturing and assembly processes.
• Previous experience with the ability to direct, lead and mentor engineers with respect to company
engineering procedures, new product introduction, manufacturing support and tooling.
• Excellent verbal and written communication skills.
• Must be able to read, write and speak fluent English.
• Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP
principles preferred.
• Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality
standards.
• Must be able to read blueprints and interpret technical specifications and illustrations.
• Strong computer skills associated with MS Office suite, Minitab, and SolidWorks a plus.
• The capacity to work well under pressure, change priorities on the fly, and take on new
challenges.
• Project management skills and the ability to work to tight deadlines.
• Teamwork and people management skills.
• Experience associated with continuous improvement activities like participation in Kaizen events
using lean manufacturing principles.
• A practical and logical approach to problem solving using lean six sigma concepts.
• Willingness to travel if required (
WHAT WE PROVIDE FOR YOU:
Health care and well-being programs including medical, dental, vision, wellness, and Employee Assistance programs
Paid time off
Training and career development
Employee recognition program
Tuition assistance
401(k) retirement savings with a company match
Clean, climate controlled and well-lit production areas
This is not a remote position
WORKING ENVIRONMENT:
Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this 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.
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