Sr. Packaging Design Engineer

This position is eligible for a $5,000 sign on bonus.

This position is located on-site based out of our corporate headquarters in Brooklyn Park, MN.

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 Sr. Engineer, Packaging Design is primarily responsible for defining, developing, and designing packaging for medical devices.

Owns efforts in developing solutions to packaging class II and class III medical products by translating requirements from the customer into realized designs.

Able to multitask and run multiple projects while meeting customer commitments. This position will work with New Product Introduction (NPI) and Sustaining teams to support the transfer of new products into production.

ESSENTIAL RESPONSIBILITIES

Owns the design and development of medical device packaging through :

o Transformation of internal and external customer inputs and requirements into results

o Developing packaging design specifications

o Generate 3D models and engineering drawings utilizing Solidworks

o Working with internal and external sources to create concepts and prove function

o Planning and leading test methods, design verification and validation activities

• Host design reviews with internal and external stakeholders
• Manage workload to support various projects
• Maintain compliance to procedures and regulatory requirements
• Represents Packaging Engineering in cross functional teams as assigned.
• Provides regular status updates to management and or customer
• Writes / updates work instructions, specifications, verification protocols, and various technical documents
• Reliable, consistent, and punctual attendance is an essential function of the job
• Complies with company, quality, and safety standards, policies, and procedures.
• Other duties as assigned.

This is not a remote position.

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 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).
• Use of mechanical design (SolidWorks, PTC or other), statistical analysis (MatLab, MiniTab or other)
• Knowledgeable in ISO, ASTM, ISTA standards and test methods related to packaging
• Experience with terminally sterilized package design, materials, sealing methods, operating room procedures and sterilization methods.
• FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
• Proficiency with Solidworks required
• Computer skills associated with Microsoft software and Labeling software.
• 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.
• Must be able to read, write and speak fluent English
• Excellent reading, writing, communication, and organizational skills
• Maintains performance with changing priorities under supervision
• Possess team collaboration skills

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.