R&D Packaging Engineer 2
Share
Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Overview
The Packaging Engineer 2 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 Packaging Engineer 2 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:
- Bachelors degree in Mechanical Engineering Packaging Science or closely related field and 3 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.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
