Risevoic
Senior R&D Packaging Engineer
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 3 January 2026
Overview
The Senior Packaging Engineer uses their experienced in medical device packaging to design and develop solutions for new and modified products. This includes supporting product design, verification testing, regulatory compliance, process validation and manufacturing line establishment. A Senior Packaging Engineer leads packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs, Operations, Quality Assurance, Clinical Affairs, and other Engineering personnel.
Responsibilities
- Apply packaging design principles from the Medical Device/Pharma field to develop packaging designs that meet company, customer and industry standards.
- Works with suppliers to spec and acquire packaging materials.
- Coordinate distribution simulation and packaging testing.
- Develop and maintain department standards in packaging.
- Ability to lead multiple projects to successful completion with tight time lines and critical deliverables.
- Ensure compliance of equipment and packaging designs with company quality system.
- Coordinate or perform verification and validation testing of packaging designs and manufacturing methods.
- Write and maintain appropriate documentation per the company quality system.
- Evaluate issues with existing packaging and implement corrective actions.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
Qualifications
Qualification/ Educational Requirements:
- Bachelor's degree in Mechanical Engineering, Packaging Science or closely related field and 5 years experience; or experience of such kind and amount as to provide a comparable background
- Experience with medical packaging materials (Tyvek, PE/PET films, PETG trays, etc.)
- Experience with environmental and regulatory requirements and standards that relate to medical packaging design and testing (i.e. ASTM F1886, F88, F2096, D4169, and ISO 11607)
Physical Requirements:
- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Researches and designs using standard computer equipment.
- The employee is frequently required to stand; walk; use hands to grasp, feel or touch; reach with hands and arms; climb or balance; stoop; kneel; crouch; or crawl; and talk; or hear.
- Moderate exposure to noise level in the work environment that is moderate to occasionally loud.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
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Frequently asked questions
Senior R&D Packaging Engineers excel in medical packaging materials like Tyvek and PETG trays, alongside expertise in regulatory standards such as ASTM and ISO 11607. Their advanced know-how in validation testing and cross-functional collaboration sets them apart in medical device packaging innovation.
Professionals often start in associate or entry-level packaging roles, gaining experience with materials and regulatory compliance. Progression leads to senior positions like R&D Packaging Engineer, where leadership in project management and quality assurance becomes central, paving the way toward managerial or specialist roles.
Balancing strict regulatory requirements, material compatibility, and manufacturing feasibility forms the core challenge. They must navigate tight timelines, coordinate testing protocols, and troubleshoot packaging failures while ensuring compliance with quality systems in a fast-paced, multidisciplinary environment.
In Bloomington, certifications related to medical device packaging standards like ISO 11607 and ASTM testing methods are highly regarded. Local employers also value experience with FDA regulatory frameworks and environmental testing protocols specific to the regional healthcare manufacturing landscape.
Bloomington's growing medical device industry sustains a steady demand for seasoned packaging engineers. Companies like Cook Medical drive opportunities for expertise in packaging validation and regulatory compliance, with local hiring reflecting competitive needs for innovation and quality assurance.
Cook Medical emphasizes cross-functional leadership, requiring packaging engineers to collaborate closely with regulatory, clinical, and quality teams globally. This integrative approach, coupled with a focus on medical device packaging innovations, sets a unique standard compared to typical engineering roles.
This role demands rigorous adherence to Cook Medical’s quality protocols, including precise documentation, validation testing, and corrective action implementation. Engineers act as custodians of packaging standards, ensuring all processes align with both internal and external regulatory mandates.
Senior R&D Packaging Engineers in Bloomington typically earn between $90,000 and $115,000 annually, reflecting the specialized skills in medical packaging and regulatory compliance. Compensation varies with experience, certifications, and the complexity of project leadership within the medical device sector.
Candidates should emphasize a bachelor's in mechanical engineering or packaging science, proficiency with medical packaging materials like Tyvek and PETG, and hands-on experience with ASTM and ISO standards. Demonstrated success in verification testing and regulatory compliance will strengthen applications.
Environmental and regulatory criteria, such as ASTM F1886 and ISO 11607, dictate material selection, testing methods, and design durability. Engineers must ensure packaging withstands distribution stresses while meeting safety and sterility requirements, balancing innovation with strict compliance mandates.