Engineer/Principal Packaging Engineer Job in Dover 44622, Ohio US
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer’s 2010 sales were approximately $4.2 billion. The Company is supported by the efforts of approximately 8,000 employees worldwide.
As a division of Zimmer, Zimmer Surgical develops, manufactures and markets surgical products that support Zimmer Reconstructive, Spine, Dental and Trauma product systems in the operating room environment, with a focus on blood management, surgical wound site management, pain management and patient management products. Among its products are bone cement used by orthopaedic surgeons to securely fix implants to patient bones, the market-leading Zimmer A.T.S.® Automatic Tourniquet Systems family of products, wound debridement systems, traction equipment, orthopaedic power equipment and orthopaedic softgoods. Zimmer Surgical is headquartered in Dover, Ohio.
DESCRIPTION:
The Principal Packaging Engineer will be responsible for the designing, developing, and validating a wide variety of package designs to support the development of orthopedic-related medical devices and associated devices that are of a complex nature. He or she will work in a matrix/cross functional product development environment and be primarily responsible for the project leader's role to bring a package design from concept through commercialization. Coordination of internal and external/contractor resources to develop solutions required to solve complex engineering problems will be a primary focus. Experience with new technologies that will drive packaging innovation resulting in competitive advantages across global platforms is desired. Strong communication, teamwork and organizational skills are essential. A thorough understanding of ISO11607 and Process Validation is a must. Knowledge of ISO13485 is strongly preferred.
Directs the generation of prototype samples to evaluate new materials and/or design concepts.
Leads the Risk Analysis role for the package design and process FMEA's.
Develops comprehensive validation plans, generates protocol and reports.
Manages collaboration across multiple divisional facilities.
Identifies new technologies that will provide innovation and product differentiation.
REQUIREMENTS:
B.S. in Engineering or science degree required; packaging engineering degree preferred
M.S. /MBA preferred plus eight (8) or more years of sterilized medical device packaging experience required, or an equivalent combination of experience/education wil be considered
Advanced knowledge of ISO11607 (Packaging Validation).
Complete knowledge of packaging and regulatory standards that drive the medical device industry.
Ability to analyze and develop new testing criteria and requirements.
Identify customer requirements for a new package designs.
Demonstrated ability to lead and influence all parts of the organization.
Microsoft Office Suite and Project; Demonstrated ability to learn and apply multiple skill sets