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Principal Project Lead/Packaging Engineer

Northern, California

Job ID: 1955 Industry: Engineer/Marketing Hybrid

Position Overview

Exciting Principal Packaging Engineer opportunity in a leading medical device company with a strong corporate culture of rewarding and advancing employees. You will perform professional engineering work in the conception, specification, design, manufacture and testing of medical device packaging. This person will work with design teams & suppliers by managing the process and the development of new packaging solutions through the full life cycle, including conceptual design, process development, and continuous improvement.

CPP preferred

Primary Responsibilities

  • Develop and maintain a professional knowledge of emerging trends in packaging technology and materials through continuing education industry recognized credentials and show evidence of continuous learning to become or advance your credibility as a thought leader in the Packaging Community
  • Develop and execute Best Practices for packaging for existing and new Class II and III implantable medical products.
  • Identify viable primary packaging options and alternatives, defining technical parameters and contribute to process development and support for packaging assemblies for manufacturing
  • Contribute to the design and validation of implantable medical devices including related Medical instruments, such as case and tray devices using your experience with Design for Lean Sigma (DFLS), Design for Manufacturability (DFM), process development and design of experiments (DOE) methodology.
  • Utilize knowledge of FDA and ISO 13485 and Design Control requirements related to packaging and labeling, ensuring robust package validation and qualification to develop & execute on plans to establish proof of shelf life, accelerated and real time
  • Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs using your experience with Design Verification and Process Validation.
  • Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors.

Position Requirements

  • Bachelors or Masters Packaging or related engineering field, preferably Mechanical or Materials
  • Certified Packaging Professional (CPP) preferred, not required
  • 5+ years hands-on experience in a highly regulated industry, medical device sterile packaging design and development preferred
  • Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
  • Ability to travel up to 15%-20%, both domestic and international.
  • Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods and sterile barrier sealing equipment and processes
  • QSR familiarity and  experience with Solidworks, MiniTab, Microsoft Project, MatrixOne, Agile, QAD. and SAP software.

Base plus Bonus: VERY COMPETITIVE; Commensurate with education & experience
Travel: up to 20%
Direct reports: Initially high level individual contributor
Years of experience: 5+ with a Masters; 7 with a Bachelors
Education  BS or MS Packaging or related engineering field, preferably Mechanical or Materials
CPP preferred
Location: Northern California; Relocation assistance available

NOTE: This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

CPP, Certified Packaging Professional, 13485, 11607

Arshad Alam

Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.

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