Packaging Engineer II

Orthofix Holdings, Inc.; Carlsbad (CA); On-site; USD 85,000 - 105,123; Full time

Job summary

Orthofix Holdings, Inc. is seeking a Packaging Engineer II in Carlsbad, California, responsible for designing and validating packaging systems for spinal implants and surgical instruments. The role involves working with technical teams and vendors to ensure compliance with regulations, creating and implementing design plans, and supporting manufacturing processes.

A bachelor’s degree in Packaging Engineering and 2-5 years of relevant experience in Class II medical devices are required. The anticipated salary is $85,000 to $105,123 annually, plus bonuses.

Qualifications

• 2–5 years packaging experience in Class II medical device environment.
• Experience in packaging equipment qualifications and validations.
• Knowledge of FDA regulations, GMP, and ISO requirements.

Responsibilities

• Design and validate packaging systems for spinal implants and instruments.
• Launch design and validation plans for packaging projects.
• Collaborate with cross-functional teams to meet project goals.

Skills

Packaging engineering fundamentals

Attention to detail

Communication skills

Analytical mindset

MS Office proficiency

Education

Bachelor’s degree in Packaging Engineering

Tools

Pro-E

Creo

SolidWorks

Job description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• Experience in medical device ERP, CAD drafting and modeling using Pro‑E, Creo, SolidWorks, or similar.
• Familiarity with ASTM D4169, ISO11607, and ISO11137.

Physical Requirements

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.

Salary

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.

EEO Statement

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 service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision‑making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.