Job Title: Packaging Engineer

Job Description

We are seeking a skilled and experienced Medical Device Packaging Engineer to support a critical project involving the acquisition of another medical device company. This role will focus on addressing Design History Files (DHFs) and identifying gaps within them, working on labeling, conducting ageing studies, and optimizing packaging solutions. The successful candidate will also be responsible for protocol development, bio-compatibility assessments, and providing project management support.

Responsibilities

• Review and address gaps within Design History Files (DHFs) to ensure compliance and completeness.
• Develop and optimize labeling processes and conduct ageing studies to ensure product integrity over time.
• Collaborate with clients to optimize packaging solutions, ensuring they meet regulatory and quality standards.
• Create and implement protocols for packaging processes, ensuring consistency and reliability.
• Conduct bio-compatibility assessments to ensure packaging materials are safe for medical use.
• Provide support to project management teams, ensuring timely and efficient project execution.
• Work closely with current third-party vendors responsible for packaging to gather designs and requirements, and facilitate the transition of these processes internally.

Essential Skills

• Bachelor's degree in Engineering, preferably in Packaging Engineering.
• 4-8 years of experience in packaging development for medical device companies.
• Experience with packaging designs and testing for ageing studies, protocol development, and biocompatibility.
• Proficiency in SolidWorks.
• Knowledge of Design History Files (DHFs) remediation.
• Understanding of lean manufacturing principles.

Work Environment

This position offers a hybrid work environment with 2-3 days offsite post the initial training period. The initial training period will be 3-4 weeks onsite, followed by a more remote work arrangement as time progresses.