Engineering II, Packaging

Job Overview

Reporting to a Manager of Packaging Engineering for Tissue Technologies, you will serve as an individual contributor packaging engineer. Your role involves designing, developing, validating, and improving package systems for sterile and non‑sterile medical devices, ensuring they meet end‑user functionality, safety, manufacturability, regulatory, sustainability, and business objectives.

• Plan, design, develop, validate, and continuously improve package systems for medical devices.
• Define and establish design requirements, performance criteria, and business objectives through collaboration with healthcare providers and cross‑functional teams.
• Lead packaging engineering activities, working with R&D, Quality, Regulatory, Labeling, Operations, suppliers, and other stakeholders from exploratory design through commercialization.
• Assist in developing packaging concepts, tooling, and equipment schedules and cost estimates.
• Generate test plans, write protocols, and conduct design verification/validation and process qualification (IQ, OQ, PQ) for packaging equipment.
• Maintain complete records of packaging processes, design activities, test data, and statistical analyses, and produce reports with data‑driven conclusions.
• Execute packaging testing, define statistical sample sizes, and identify root causes in data analysis.
• Perform additional duties as assigned, including travel up to 25% domestic and international.

• Bachelor’s degree in Packaging Engineering or a related science field (advanced degree preferred).
• 3‑5 years of experience in medical device packaging (or 2 years with an M.S., 1 year with a Ph.D.).
• Strong knowledge of packaging materials, structures, components, and conversion processes.
• Familiarity with FDA, ISO, ASTM, and ISTA packaging and labeling requirements (including ISO 11607, ISO 13487, ISO 14971, and FDA 21 CFR 820).
• Experience with GD&T methodologies, project management, risk analysis, and statistical analysis (DOE, ANOVA, capability studies).
• Excellent technical writing and documentation skills; strong written and verbal communication.
• Proficiency with MS Word, Excel, Project, and Visio.
• Authorized to work in the United States.

• Ability to sit and work on a computer for extended periods; lift and carry up to 50 lbs.
• Work in a mechanical laboratory environment meeting OSHA and cGLP requirements.
• Travel required 15%–25% of the time, domestically and internationally.

• Position located in Columbia, MD – hybrid schedule, three days onsite.
• Salary range: $71,300.00 – $97,750.00 USD (commensurate with experience and qualifications).

• Medical, dental, vision, life insurance.
• Short‑term and long‑term disability insurance.
• Business accident insurance, group legal insurance, and 401(k) savings plan.

Integra Life Sciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, sex, national origin, age, disability, protected veteran status, or any other legally protected characteristic. The company provides reasonable accommodations for qualified employees and applicants with disabilities in accordance with the ADA.