Packaging Design Engineer II

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Packaging Design Engineer II 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. There are strong analytical skills required 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. Able to multitask and run multiple projects while meeting customer commitments.

Key Responsibilities:

• Owns the design and development of medical device packaging through:
  
  
  
  • Transformation of internal and external customer inputs and requirements into results
  • Developing packaging design specifications
  • Generate 3D models and engineering drawings utilizing Solidworks
  • Working with internal and external sources to create concepts and prove function
  • Planning and leading test methods, design verification and validation activities
  
  
  
  
• Host design reviews with internal and external stakeholders
• Manage workload to support various projects
• Creates product designs and specifications for medical device packaging that meet customer and regulatory requirements.
• Maintain compliance to procedures and regulatory requirements
• Provides regular status updates to management and/or customer
• Plans, prepares, and leads test methods, design verification protocols; and supports the execution of packaging validations.
• Writes/updates work instructions, specifications, verification protocols, and various technical documents
• 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.

Must Have:

• A Bachelor's degree (STEM engineering discipline preferred) and 2 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)
• Computer skills associated with Microsoft software
• 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
• Strong mechanical aptitude

Salary Range: 80000 to 97000

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.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.