Freelance Sterility Assurance Jobs (NOW HIRING)

We’re seeking a Packaging Engineer to support the design, development, testing, and validation of packaging solutions for orthopedic implants and surgical instruments.

Working under the direction of a Project Leader or Manager, you’ll contribute to new product development and product launches. Your work will help ensure packaging meets quality, regulatory, manufacturing, usability, and cost requirements.

This role is well suited to an entry-level engineer with a degree in Packaging Science, Packaging Engineering, Engineering, or a related field. Academic or practical experience with medical device packaging, sterile packaging, packaging design, testing, or validation is welcome.

• Duration: 12 months
• Employment type: C2C / freelance
• Location: Warsaw, Indiana, United States
• Work mode: Hybrid or on-site

Key responsibilities:

• Design and develop packaging solutions for orthopedic implants and surgical instruments.
• Create packaging concepts that support manufacturability, inspectability, functionality, and cost efficiency.
• Produce prototype models and samples to evaluate and refine packaging concepts.
• Support packaging tests, product evaluations, and validation activities.
• Write test protocols and assist with the analysis and documentation of test results.
• Coordinate product and packaging evaluations with surgeons and cross-functional stakeholders.
• Develop and maintain packaging specifications and design assurance documentation.
• Provide manufacturing support during packaging development and product launches.
• Work with project teams to meet applicable quality, regulatory, and manufacturing requirements.
• Support packaging development throughout the product development process.

Required qualifications:

• Bachelor’s degree in Packaging Science, Packaging Engineering, Engineering, or a related field.
• 0-1 year of professional experience in packaging engineering, packaging development, product development, or a related engineering discipline.
• Knowledge of design for manufacturability and cost-effective product design.
• Understanding of packaging design, prototype development, testing, and validation.
• Ability to prepare technical documentation, specifications, protocols, and test reports.
• Strong analytical, problem-solving, communication, and collaboration skills.

Preferred qualifications

• Academic or professional exposure to the medical device industry.
• Knowledge of orthopedic implants, surgical instruments, or sterile medical products.
• Familiarity with sterile packaging and sterile barrier systems.
• Knowledge of ISO 11607, ISO 13485, and/or FDA requirements.
• Exposure to packaging validation, product testing, design assurance, or regulated product development.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.