Packaging Engineer II

Job Overview

As a Packaging Engineer II on our Packaging team, you’ll design, test and validate packaging systems for spinal implants, biologics, and surgical instruments, ensuring compliance within a design control environment.

• Work within a project team to gather user needs and design inputs, then be responsible for the design of new packaging systems and related packaging process steps and processing equipment for a variety of spinal implants, biologics, and surgical instruments.
• Create and launch design and development plans, verification and validation plans for packaging related projects within a design control environment.
• Work with vendors and Operations team on technical issues while supervising packaging designs throughout the manufacturing process.
• Significant involvement in packaging system and process transfer to Manufacturing/Operations and ongoing support after commercialization.
• Effectively interact with cross‑functional teams within Marketing, Purchasing, Quality, Manufacturing, and Operations to drive project plans and achieve project objectives.
• Support investigations relating to packaging issues, product release performance, and/or customer issues.
• Partner with Quality and Regulatory Affairs colleagues to ensure compliance with regulatory authority guidance for sterile operations.
• Create standard operations procedures, standard test procedures, and other related records.
• Identify and lead cost reduction opportunities.

• Bachelor’s degree in Packaging Engineering.
• 2–5 years packaging experience in a Class II medical device environment.
• Experience performing and/or supporting packaging equipment and utility qualifications and validations.
• Understanding of packaging engineering fundamentals and technical knowledge of packaging materials, equipment, and supporting utilities.
• Demonstrated success in creating and maintaining design control documentation.
• Experience with medical device packaging/labeling equipment design/validation and manufacturing process development.
• Knowledge of ASTM package testing methodologies and test standards, risk management processes, and FDA regulated environment, package protocols, GMP, and ISO requirements.
• Ability to effectively communicate verbally and through written correspondence with all levels of peers and leadership within the Company, surgeons, suppliers, etc.
• Proficiency with MS Office, specifically Excel and PowerPoint.
• Ability to work creatively, prioritize, and accomplish team goals and initiatives amidst competing priorities.
• Analytical mindset with strong attention to detail, and ability to problem‑solve and identify solutions in a high‑growth and fast‑pace environment.

• Experience in medical device ERP, CAD drafting and modeling using Pro‑E, Creo, Solid Works, or similar.
• Familiarity with ASTM D4169, ISO
  11607, and ISO
  11137.

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

No additional physical requirements or essential functions for this position.

The anticipated salary for this position for an employee who is located in California is $85,000 to $105,123 per year, plus bonus, and benefits.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform…