Packaging Engineer
This role will be responsible for overall package engineering, labeling and sterilization related support for new product development teams. As a Packaging Engineer, you will be responsible for development of advanced packaging, labeling and sterilization concepts for sterile & non-sterile medical device, assemblies, and associated components. The role will lead and support cross functional teams such as R&D, operations, Regulatory, Quality and supply chain to drive packaging and sterilization related activities and strategies to improve time to market capabilities for Alphatec products.
Essential Duties And Responsibilities
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $75,000 to $95,000 Full-Time Annual Salary
Essential Duties And Responsibilities
- Manages packaging development and improvement projects to meet Company, and regulatory needs
- Translates requirements for sterilization standards such as ISO 11137, ISO 11135 and novel sterilization methods to develop sterilization validation plans
- Develop and maintain routine Dose audit, bioburden and Bacterial Endotoxin testing schedules for sterile implants and disposables
- Creates packaging, labeling and sterilization related SOP's and Work Instructions
- Translates requirements for ISO 11607-1{{{{:}}}}2006 requiring packaging for terminally sterilized products to internal product development teams and packaging personnel supporting these operations
- Develops and executes test methods, validations, and protocols for packaging, sterilization related developments and projects
- Supports packaging, labeling and sterilization related manufacturing issues, CAPA's, SCARS and audits
- Develop label bar codes, symbiology, and labeling processes when appropriate
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Familiar with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures
- Experience in packaging engineering, structured problem solving, use of statistical tools, smartsheet and monitoring tools for sterility assurance program
- Working knowledge of packaging and sterilization standards such as ISO 11607, ISO 11137, ISO 11135, and ASTM D4169
- Working knowledge of labeling requirements and standards for medical devices
- Proficient with Solidworks to create packaging concepts and drawings
- Ability to demonstrate technical expertise and communicate with internal and external customers and executive management.
- 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
- 1-3 years' experience in medical device environment
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $75,000 to $95,000 Full-Time Annual Salary
-
Seniority level
Entry level -
Employment type
Full-time -
Job function
Engineering and Information Technology -
Industries
Technology, Information and Internet
Referrals increase your chances of interviewing at Alphatec Spine by 2x
See who you knowGet notified about new Packaging Engineer jobs in Carlsbad, CA.
Sign in to create job alertSimilar jobs
People also viewed
-
Sr. Mechanical Design Engineer
Sr. Mechanical Design Engineer
-
Sr. Supplier Quality Engineer
Sr. Supplier Quality Engineer
-
Senior Quality Engineer
Senior Quality Engineer
-
Manufacturing Engineer
Manufacturing Engineer
-
Sr. FEA Engineer (Simulation & Optimization)
Sr. FEA Engineer (Simulation & Optimization)
-
R&D Product Development Engineer CFNJP00042727
R&D Product Development Engineer CFNJP00042727
-
Senior Mechanical Engineer
Senior Mechanical Engineer
-
Quality Engineer
Quality Engineer
-
Mechanical Engineer IV
Mechanical Engineer IV
-
Sr. Mechanical Engineer P3 (Onsite)
Sr. Mechanical Engineer P3 (Onsite)
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More