Packaging Engineer II at Orthofix – Carlsbad, California

Why Orthofix?

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

​How you'll make a difference?

As a Packaging Engineer II on our Packaging team, you’ll be responsible for designing, testing and validating packaging systems for our spinal implants, Biologics, and surgical instruments. This includes creating and documenting requirements of new packaging development including prototyping, verification/validation testing, design for manufacture, and transfer to manufacturing within a design control environment. You will help support packaging recommendations based on experience for a variety of implant (or instrument) projects and help support packaging strategies and timelines associated with individual projects. This is a highly collaborative role and you’ll partner with Product Development Engineers, Marketing, Quality, Manufacturing, Operations, and 3rd party vendors/suppliers.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

• 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 on-going 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

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Bachelor’s degree in Packaging Engineering

Experience, Skills, Knowledge and/or Abilities:

• 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, and risk management and processes

• Knowledge and understanding of 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 PPT

• 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

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• No additional requirements

Additional Experience, Skills, Knowledge and/or Abilities:

• Experience in medical device

• ERP experience

• CAD drafting and modeling, using Pro-E, Creo, SolidWorks, or similar

• Familiarity with ASTM D4169, ISO 11607, and ISO 11137

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

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.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status.

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.

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.