What are the responsibilities and job description for the Packaging Engineer position at Intellectt Inc?
This Packaging Engineer (Consultant) will provide guidance, ownership, and execution of all packaging design, sterilization validation, and sustainability efforts for multiple Class III medical devices.
This person will not be running the actual test- the tests will be done at an external lab . The consultant will use the client’s template to write the protocol. This will go out to the lab for testing, when it comes back, the consultant will write the documentation.
Principle Duties And Responsibilities
Qualifications
This person will not be running the actual test- the tests will be done at an external lab . The consultant will use the client’s template to write the protocol. This will go out to the lab for testing, when it comes back, the consultant will write the documentation.
Principle Duties And Responsibilities
- Design and validation testing of intercompany shipment containers for all products including the clients heart pump and all associated accessories
- Define and execute real-time and accelerated aging testing to ensure sterile barrier durability
- Assess human factors and design validate commercial device packaging to maximize customer satisfaction
- Coordinate with suppliers to develop packaging and shipping methods that ensure raw component quality and durability
- Coordinate with sterilization facility to ensure routine revalidation and device testing is aligned with industry and regulatory requirements One project= in 2023 a couple chillers need to be installed b/w 23 and 24 (May is the plan) just need to investigate piping
Qualifications
- BS in Packaging Engineering or directly related scientific discipline, MS Preferred
- 8-10 years of work experience in packaging design or applications roles; med device experience preferred
- Familiarity with ASTM, ISO and other industry standards applicable to med device packaging and sterilization
- Must be experienced with Engineering CAD software. SolidWorks and EPDM preferred.
- Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
- Ability to prioritize & execute effectively to meet strict deadlines
- Must be proficient in Microsoft Office Suite. Working knowledge of SAP preferred.
- May require up to 10% travel – internal U.S. (Likely just Baltimore).
- Proven experience in Med-Device packaging validation.
- In-depth knowledge and hands-on experience with MDR (Medical Device Regulation).
- Experience with ISO 11607-1 and 11607-2
- Demonstrated ability to draft protocols and determine appropriate tests for external lab submission.
- Proficient in documenting procedures comprehensively, particularly when interpreting results from external labs.
- Strong technical background with a focus on engineering and thought processes.
- Capable of strategic thinking and problem-solving, emphasizing the conceptual aspects over merely executing work instructions.
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