Stellar Consulting Solutions, LLCFranklin Lakes, 35 mi from Stamford
standards and regulatory requirements for medical devices (i.e. ISO11607, EUMDR, etc.)
Qualification: Bachelor Degree equivalent in Packaging, Mechanical Engineering, Materials Engineering or in a related field of study.
Experience: Minimum 3 years...
LanceSoft, Inc.Franklin Lakes, 35 mi from Stamford
NO C2C/ H1B Candidates please. ONLY W2 candidates.
Description:
Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports.
Prepare Change Control...
Interparfums, Inc.New York, 34 mi from Stamford
Management to join our team in New York, NY. This role will report into the Chief Operations Officer. This position oversees the New Product Development (NPD) department in Operations, comprised of Packaging Development/Engineering & Sourcing and Project...
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Staff Packaging Engineer
Katalyst Healthcares & Life Sciences | Franklin Lakes | www.resume-library.com |
Responsibilities:
Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products.
Technical leader of the design, development, and qualification of packaging systems for new and existing products. Independently develops and drives strategies for:
Design Development: Develops packaging designs, DOE's, edge of failure analysis, process development and design verification.
Design for Manufacturability (DFM): Assess manufacturability, material selection, development of packaging
processes for new or existing packaging systems.
Defining Packaging Requirements: Translate customers and regulatory needs into engineering requirements and specifications.
Leads multiple, complex, high-volume projects at one time.
Implement DFSS tools through the design selection and development process, deploying statistical and analytical tools.
Internal technical packaging SME and mentor for other packaging engineers
Responsibilities:
A Bachelor's degree in Packaging, Mechanical, Materials Engineering or a related Science/Engineering field is required. A post-graduate degree (MSc or PhD) is preferred.
A minimum of 8 years of experience in packaging of medical devices, pharmaceutical and/or combination products is required.
A demonstrated track record of technical influential leadership and delivering results
Excellent oral, written, and interpersonal communication skills
Ability to tactfully advise decision-maker
Detailed knowledge of ISO-(phone number removed) and -2, ISO 13485, medical device packaging ASTMs, cGMP and medical device validation methodology
Packaging systems, medical device class II and III, design verification and validation experience for primary, secondary and tertiary; flexible and rigid packaging applications
Experience with different medical device package designs (i.e. FFS pouch, top lid rigid trays, pre-made pouches, etc)
Proficiency using solid modeling tools (SolidWorks preferred)
Proven experience on forming and sealing packaging processes
Experience using design for six sigma (DFSS) elements for packaging systems design and/or analysis
Statistical analysis using Minitab software (i.e. DOE, process capability, analysis of variances)
Understanding of sterilization technologies (i.e. radiation and gas) and their impact on medical device packaging
Proven expertise on technical critical thinking interpreting data results, demonstrating equivalency and/or technical rationales for medical device packaging design systems
Proven experience following medical device design control
Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products.
Technical leader of the design, development, and qualification of packaging systems for new and existing products. Independently develops and drives strategies for:
Design Development: Develops packaging designs, DOE's, edge of failure analysis, process development and design verification.
Design for Manufacturability (DFM): Assess manufacturability, material selection, development of packaging
processes for new or existing packaging systems.
Defining Packaging Requirements: Translate customers and regulatory needs into engineering requirements and specifications.
Leads multiple, complex, high-volume projects at one time.
Implement DFSS tools through the design selection and development process, deploying statistical and analytical tools.
Internal technical packaging SME and mentor for other packaging engineers
Responsibilities:
A Bachelor's degree in Packaging, Mechanical, Materials Engineering or a related Science/Engineering field is required. A post-graduate degree (MSc or PhD) is preferred.
A minimum of 8 years of experience in packaging of medical devices, pharmaceutical and/or combination products is required.
A demonstrated track record of technical influential leadership and delivering results
Excellent oral, written, and interpersonal communication skills
Ability to tactfully advise decision-maker
Detailed knowledge of ISO-(phone number removed) and -2, ISO 13485, medical device packaging ASTMs, cGMP and medical device validation methodology
Packaging systems, medical device class II and III, design verification and validation experience for primary, secondary and tertiary; flexible and rigid packaging applications
Experience with different medical device package designs (i.e. FFS pouch, top lid rigid trays, pre-made pouches, etc)
Proficiency using solid modeling tools (SolidWorks preferred)
Proven experience on forming and sealing packaging processes
Experience using design for six sigma (DFSS) elements for packaging systems design and/or analysis
Statistical analysis using Minitab software (i.e. DOE, process capability, analysis of variances)
Understanding of sterilization technologies (i.e. radiation and gas) and their impact on medical device packaging
Proven expertise on technical critical thinking interpreting data results, demonstrating equivalency and/or technical rationales for medical device packaging design systems
Proven experience following medical device design control
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