Arthrex · 2 weeks ago
Sr. Engineer II - Packaging
Naples, FL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. They are seeking a Sr. Engineer II - Packaging to provide packaging engineering support for design engineering projects and assist in achieving packaging engineering development goals. The role involves coordinating packaging development activities, overseeing packaging design validation, and supporting regulatory documentation.
Health CareMedical Device
Responsibilities
Coordinate Packaging Development activities for new MPI’s and product improvement projects
Create and maintain packaging engineering specifications utilizing CAD, 3D modeling software, or other software tools
Create and maintain packaging designs for sterile and non-sterile products
Select appropriate packaging materials based on product and sterilization requirements
Create and maintain Packaging Instruction documents for the final manufacturing packaging assembly of finished devices
Communicate (not execute) packaging process validation activities with manufacturing or designated design team member for Arthrex products
Coordinate and execute packaging design validation activities post packaging process approval
Oversee any required package testing to assure viability of packaging/product construct for sterile and non-sterile barrier protection
Generating protocols, test reports, and engineering adoptions and maintenance of test documentation per approved documentation system per quality standards
Ensure essential packaging development activities are completed prior to packaging design transfer activities
Coordinate Instrument Case development activities for new MPI’s and product improvement projects
Coordinate and Create Instrument Case Layouts with Design Team and Contract Suppliers
Create and maintain Instrument Case Specifications
Oversee Design Verification and Validation activities for Instrument Cases
Lead Instrument Case project when Instrument Case is a standalone MPI
Provide support for packaging engineering related CAPA’s
Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits
Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance
Communicate effectively with Design Team members and Contract Suppliers using project management tools, written, and verbal communication
Support product design changes to develop and improve existing products that affect existing packaging
Oversee any required package testing to assure viability of packaging/product construct and sterile barrier protection
Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits
Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance
Communicate effectively with Design Teams and Contract Suppliers using project management tools, written, and verbal communication
Qualification
Required
Bachelor's degree in Engineering required; preferably in Packaging Engineering
Minimum of 8 years of experience in Packaging Design and Development or Manufacturing required
Advanced capabilities in designing complex packaging designs and packaging instructions using a CAD program (AutoCAD or Solidworks) required
Proficient at leading DHF projects for Packaging only and Instrument Case projects
Advanced knowledge of packaging validation process as required by quality and regulatory standards
Advanced capabilities of researching new packaging materials and suppliers for manufacturing process improvements and/or cost reductions
Advanced capabilities in leading Global Packaging Projects for design and/or packaging process improvements
Advanced ability of writing and approving technical documentation internally
Advanced capability of reviewing and approving technical documentation from external packaging subcontractors
Able to coach, mentor, and supervise technicians and/or junior packaging engineers
Proficient at creating packaging procedures and providing training on procedures
Advanced knowledge of design and manufacturing processes and ability to incorporate improvements into designs
Proficient at specifying and communicating design, process, or other packaging related improvements with manufacturing and contract packagers
Proficient at supporting and participating in internal and external audits in support of regulatory compliance
Preferred
Medical device packaging or manufacturing environment experience preferred
Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Deferred Compensation Plan (DCP)
Company
Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.
10001+ employees
H1B Sponsorship
Arthrex 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 (30)
2024 (22)
2023 (13)
2022 (13)
2021 (9)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Eric Butler
Sr. Director - Surgical Imaging & Integration
Kazu Miyahara
Senior Engineering Manager
Recent News
2025-12-24
Company data provided by crunchbase