Sr. Packaging Engineer
|January 08, 2013 - February 08, 2013|
|Location:||St Paul, MN|
|Employment Type:||Full Time|
|Description:||Title: Senior Packaging Engineer |
Reports to: Vice President of Operations
Summary: This position is responsible for managing all aspects of design, development, testing, and validation of packages and packaging systems for medical devices at Innovize. These duties include developing sterile-barrier pouch designs, detailed specifications and tolerances, material selection, supplier selection, label designs, secondary packaging configurations, test methods, and authoring IQ/OQ/PQ protocols and reports. This position is responsible for packaging equipment selection, procurement, buy-off, installation, debug, and qualification. Additionally, this position will lead the overall company-wide packaging strategy to make Innovize a world-class leader in manufacturing sterile, packaged, wound care products.
|Duties:||Duties/Responsibilities include but are not limited to:|
•Ensure that a Job Hazard Analysis is completed on all new packaging equipment and processes prior to release for production use.
•Articulate and drive the overall company-wide packaging strategy that ensures Innovize becomes a world-class leader in manufacturing sterile, packaged, wound care products and develop the associated Standard Operating Procedures (SOPs) to ensure success.
•Provide the lead technical role in managing the design, development, testing, and validation of packages and packaging systems for medical devices at Innovize.
•Develop sterile-barrier pouch designs, detailed specifications and tolerances, material selection, supplier selection, label designs, secondary packaging configurations, test methods, and authoring IQ/OQ/PQ protocols and reports.
•Provide the lead technical interface with customers, auditors, material suppliers, test labs, outside contractors, and the Innovize Quality/Engineering/Sales teams for all packaging related issues.
•Understand and comply with GMP, FDA, and ISO13485 requirements.
•Establish timelines, budget estimates, and resource requirements for package development projects and drive the projects to successful completion.
•Complete other duties as assigned.
•Accountable for meeting Project Management goals.
•Accountable for meeting Learning and Development goals.
•Accountable for meeting Gross Margin goals.
•Accountable for meeting On-Time Delivery goals.
•Accountable for meeting Product Quality goals.
•College graduate with BSME or packaging degree and 10 years of experience developing and validating sterile pouches for high-volume disposable medical devices.
•Experience authoring and executing IQ/OQ/PQ protocols and reports, preferably for sterile wound care or similar disposable medical products.
•Experience with e-beam, gamma, and ETO sterilization methods.
•Experience leading projects with tight timelines, intense customer pressure, and critical deliverables and driving them to successful completion.
•Experience with regulatory requirements like ISO, GMP, FDA, CAPA and others.
•Experience with Lean Six Sigma Manufacturing methodology.
•Strong problem analysis and implementation skill
•Proficient PC skills.
•Excellent communication skills, written and verbal with ability to lead meetings and effectively present in front of a group and interact professionally with customers.
•Demonstrates initiative and independence: Proactively seeks new opportunities and exhibits self-confidence, is action oriented and makes things happen, despite apparent roadblocks.
•Demonstrates organization, planning, and follow-through: Plans, organizes, and schedules efficiently. Effectively manages multiple projects, establishes contingencies, delivers on promises, and completes the required documentation.
•Strong math skills with ability to understand and apply statistical techniques such as means, standard deviations, control limits, process capability (Cpks), histograms, Gage R&R, and control charting.
•Demonstrates a commitment to understanding medical manufacturing and ISO13485 regulations through active participation in company training as well as through self-education by reviewing ISO13485 regulations, reading related articles, and attending seminars.
•Ability to read blueprints, to understand geometric dimensioning and tolerances, and to sign off drawings as originator or checker. Can recommend dimensioning schemes and tolerances for pouches, primary shelf cartons, and shipper boxes.
•Ability to work effectively on computers using Microsoft Word, Microsoft Excel, Microsoft Power Point, and Minitab statistical software, to collect data, to create histograms and graphs, and to write protocols and reports.
•Able to challenge existing assumptions using a fact-based scientific approach coupled with hands-on experience and ingenuity to guide teams toward effective solutions to problems.
•Can speak, understand and write English.
•Ability to lift and carry 34 lbs.; stand, sit and walk frequently.
Innovize is an Equal Opportunity Employer.
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