ATEC Spine · 22 hours ago
Senior Packaging Engineer
Carlsbad, CA
Full-time
Onsite
Senior Level
$120K/yr - $135K/yr
5+ years expATEC Spine is a company specializing in medical devices, and they are seeking a Senior Packaging Engineer to lead packaging engineering and sterilization support for new product development. The role involves collaborating with cross-functional teams to enhance packaging efficiency and ensure compliance with industry standards.
Health CareMedical DeviceProduct Design
Responsibilities
Responsible for NPI and sustaining packaging projects to meet company goals
Responsible for the development and qualification of sterilization protocols and procedures
Interface with product development teams to design, prototype, and qualify new packaging solutions
Provide sterilization and biocompatibility technical expertise during new product development activities, process modification studies and failure investigations regarding impact to product and validated sterilization cycles
Creation, Routing, and Approval of Engineering Change Orders
Drive packaging and sterilization efficiencies, cost savings, and continuous process improvements through the application of six sigma, 5S, and lean manufacturing
Support and provide assurance that sterilization programs are aligned with broader risk management processes, addressing package stability-related risks and risks arising from the sterilization process from both a product and patient safety perspective
Support contract manufacturing in performing equipment IQ, OQ, and PQ
Maintain and update packaging and sterilization related SOP's, FRM's, Standards, and Work Instructions
Responsible for the development and execution of test methods, validations, and protocols for packaging and sterilization
Ensure adherence to the requirements of ISO 11607, ISO 11137, ISO 11135, ASTM D4169 and other related standards to internal and external stakeholders
Work with external sterilization partners to characterize and determine optimal sterilization processing parameters
Provide technical guidance and mentorship to more junior packaging engineers
Maintains up-to-date knowledge of the latest industry trends and regulatory changes
Ability to investigate complex sterilization challenges and identify opportunities for optimization
Other duties as assigned
Qualification
Required
Comprehensive knowledge of packaging and sterilization standards, as well as medical device guidelines, such as ISO 13485, ISO 11607, ISO 11137, ISO 11135, and ASTM D4169
Advanced knowledge of medical device packaging i.e. design, materials, adhesives, processes, and equipment to provide technical solutions
Proficiency in SolidWorks to create packaging concepts and drawings
Experienced with IQ/OQ/PQ related to packaging processes
Experienced with distribution testing and packaging validation equipment (environmental chambers, bubble leak testers, etc.)
Ability to manage projects from inception to completion with minimal oversight
Ability to demonstrate technical knowledge and communicate with internal and external customers
Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment
Bachelor's degree from four-year College or university in Packaging Engineering or Manufacturing Engineering
5-8 years of experience in packaging and sterilization of medical devices
Preferred
Certified Packing Professional (CPP) preferred
Company
ATEC Spine
ATEC Spine is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation.
501-1000 employees
H1B Sponsorship
ATEC Spine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (5)
2023 (5)
2022 (2)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.02BKey Investors
Squadron Medical Finance Solutions
2025-03-03Post Ipo Debt· $350M
2023-10-24Post Ipo Equity· $150M
2023-04-19Post Ipo Equity· $60M
Leadership Team
Pat Miles
Chairman & CEO
Craig Hunsaker
Executive Vice President, People & Culture
Recent News
MarketScreener
2025-11-03
2025-11-01
2025-10-31
Company data provided by crunchbase