Job Information
Cirtec Medical Packaging Design Engineer II in Brooklyn Park, Minnesota
Packaging Design Engineer II
Department: BP - Engineering
Location: Brooklyn Park, MN
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This position is eligible for a $5,000 sign on bonus.
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!
YOU ARE A PART OF:
The engineering team consisting of other engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.
JOB SUMMARY
The Engineer, Packaging Design II position is primarily responsible for defining, developing, and designing packaging for class two and three implantable medical devices by transforming customer requirements into realized designs and manufacturing processes. Required are strong analytical skills to understand customer requirements, foresee technical challenges and lead the definition of design solutions to meet customer needs, specifically; manufacturability, cost, quality, reliability, regulatory requirements, effectiveness, and safety. This position will work with New Product Introduction (NPI) and Sustaining teams to support the transfer of new products into production.
ESSENTIAL RESPONSIBILITIES
Owns design and manufacturing process development for medical device packaging through:
o Transforms internal and external customer inputs and requirements into packaging design and manufacturing process outputs.
o Develops packaging specifications.
o Generates 3D models and engineering drawings utilizing design software.
o Works with internal and external sources to create concepts and demonstrate functionally.
Plans, prepares, and leads test methods, design verification protocols; and supports the execution of packaging validations.
Creates product designs and specifications for medical device packaging that meet customer and regulatory requirements.
Makes recommendations on how to improve the quality or efficiency of a process based on data and observation.
Assists in training employees on equipment and maximizing packaging skills.
Improves quality and solves problems in packaging designs and processes.
Develops processes and procedures for projects to improve quality and cost.
Originates and maintains written technical descriptions of processes and procedures, comprehensive in scope and understandable by the audience.
Represents Packaging Engineering in cross functional teams as assigned.
Maintains compliance to procedures and regulatory requirements.
Is comfortable operating and supporting a variety of equipment including, but not limited to; computers, label printing software and printers, sterile packaging tray and pouch sealers, as well as an array of test equipment.
Understands and follows safety policies and practices, attend safety training and wear PPE as required.
Prepares Engineering Change Orders for processes and components.
Performs Corrective and Preventative Action tasks.
Is reliable, consistent, and punctual attendance is an essential function of the job.
Maintains high level expertise in their field or sector.
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 (STEM engineering discipline preferred) and 2 years of experience required; or a combination of education and relevant work experience.
2-5 years of experience in medical device packaging.
Use of mechanical design (SolidWorks, PTC or other), statistical analysis (MatLab, MiniTab or other).
Proficient working knowledge of ISO, ASTM, ISTA standards and test methods related to medical device packaging including ISO 11607.
Experience with terminally sterilized package design, materials, sealing methods, operating room procedures and sterilization methods.
General knowledge of packaging materials and experience working with packaging suppliers.
Computer skills associated with Microsoft software and Labeling software.
Comprehensive understanding of FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485).
Thorough understanding of statistical process control (SPC), protocol preparation, and medical device validations.
Familiarity with failure mode analysis, hazard analysis and other risk management procedures
Strong mechanical aptitude.
Experience using SPC & Data Analysis tools (Minitab), Process Flow software, and MS Office Suite.
Capable of prioritizing work, is well organized, and effectively manages multiple tasks.
Excellent written and verbal communication skills.
Must be able to read, write and speak fluent English.
Possess team collaboration skills.
Owns a high degree of professionalism and maintains high ethical standards.
Willingness to travel, if required.
WHAT WE OFFER
A fast-paced work environment
Paid time off
401(k) retirement savings with a company match
Clean, and well-lit production areas
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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 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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