Designer

Job Summary

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Key Responsibilities

• Support the design, development, and qualification of packaging systems for sterile and non‑sterile medical devices under the guidance of senior engineers, ensuring compliance with applicable domestic and international standards.

• Assist with the execution of design control activities for low to moderate complexity projects, including development and maintenance of packaging specifications and documentation.

• Participate in packaging development projects from concept through verification and transfer, supporting testing, analysis, and documentation activities to meet defined requirements, timelines, and packaging specifications.

• Help translate product and customer requirements into packaging and process requirements with mentorship from experienced engineers.

• Contribute as a team member on cross‑functional project teams (R&D, Quality, Manufacturing, Regulatory, Supply Chain), supporting packaging strategy discussions and execution.

• Execute assigned technical tasks with a strong sense of ownership and accountability, escalating risks or issues appropriately.

• Prepare and maintain technical documentation such as test protocols, reports, work instructions, and change control documentation in compliance with quality system requirements.

• Support packaging verification and validation activities, including sample preparation, coordination of testing, data collection, and basic data analysis.

• Apply fundamental engineering principles to solve packaging‑related problems and support continuous improvement initiatives.

• Actively develop technical knowledge in medical device packaging through training, standards review, and on‑the‑job learning.

Skill Requirements

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.

• 0–2 years of experience in packaging engineering, engineering internships/co‑ops, or a related engineering role; medical device, pharmaceutical, or regulated industry exposure is a plus.

• Basic understanding of medical device packaging concepts, including sterile barrier systems and non‑sterile packaging.

• Familiarity with relevant packaging and quality standards such as ISO 11607, ISO 13485, and packaging‑related ASTM or ISTA standards (coursework or practical exposure acceptable).

• Foundational knowledge of engineering statistics and data analysis; exposure to Design of Experiments (DOE) or Six Sigma concepts is a plus.

• Ability to support the development and documentation of packaging requirements and specifications with guidance.

• Familiarity with CAD and packaging design tools (e.g., CAPE, TOPS, Solid Works, or similar) preferred.

• Strong written and verbal communication skills, with the ability to document technical work clearly and communicate effectively within a team environment.

• Strong organizational skills, attention to detail, and willingness to learn in a regulated, quality‑driven environment.

Other Requirements

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