Cleanroom SME-Quality in Riviera Beach, FL at Tecomet

Date Posted: 5/15/2018

Job Snapshot

Job Description

Tecomet is the market leading provider of manufacturing solutions for complex, high-precision products and services for the Medical Device and Aerospace & Defense markets. Tecomet operates sixteen (16) global manufacturing facilities in five countries around the world and employs over 3,000 people.

Our Riviera Beach, Florida location is currently seeking a Cleanroom SME with experience in both Package Engineering and Cleanroom experience to lead our TecoPak medical products and lead Cleanroom.     

ESSENTIAL ACTIVITIES OF THE JOB SHALL INCLUDE:

  • Management of all packaging/labeling and clean room operations activities
  • Quoting product packaging costs with consideration for gross margin and customer expectations
  • Analysis of blueprints and customer-specified requirements to determine efficient and effective packaging methods
  • Identification of opportunities for, and implementation of, lean, cost-saving initiatives in the realm of packaging and clean room operations
  • Assisting quality engineering in determining test methods for validation of packaging processes
  • Reviewing and Approving engineering change orders from within or external customer-driven changes to product packaging or labeling
  • Creating/Reviewing applicable work instructions
  • Training packaging and labeling personnel
  • Supporting engineering/manufacturing as required
  • Manages packaging development and improvement projects to meet client, Company, and regulatory needs.
  • Creates Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality and budget.
  • Remains current on packaging innovations throughout the industry and proliferates leading technologies within the Company.
  • Reviews and approves product engineering change orders and packaging process changes, including labels specifications and packaging related content.
  • Establishes supplier quality standards and supports supplier audits as needed.
  • Maintains accurate and compliant documentation to meet Tecomet, customer, and regulatory expectations.
  • Translates requirements for ISO 11607-1:2006 for customers requiring packaging for terminally sterilized products to internal product development teams and packaging personnel supporting these operations.
  • Develops and executes test methods, validations, and protocols for packaging related developments and projects.
  • ISO 14644 Cleanroom Environments for Medical Devices
  • Basics of microbial biology and physiology;
  • Cleanroom design requirements
  • Sources of microbial contamination in cleanrooms
  • Non-viable airborne particle standards and monitoring
  • Airborne and surface microbial standards and monitoring
  • Origin and minimization of pyrogen contamination
  • Cleaning technologies and operations
  • Disinfection and sanitization materials and techniques
  • Rapid microbial monitoring methods
  • Training methods for proper contamination control
  • Device sterilization validation
  • Capable of drafting a and supporting “Sterilization Agreement essential requirements
  • Designs product packaging for TecoPak Medical products using ISO and ASTM guidelines for integrity and transportation robustness.
  • Justifies and prepares capital expenditures for new packaging processes and equipment.
  • Supports manufacturing issues, CAPA’s, SCARS and audits.
  • Develops bar codes, symbology, and labeling processes when appropriate.
  • Fosters a high level of creativity and independence in the design and development of new or improved packaging processes, systems, prototypes and projects.
  • Works with key functions to design packaging through the use of appropriate structure analyses, test methods, design methodologies, feasibility justification, and business case processes.
  • Drives the interaction of key package, product, process and Supply Chain interfaces and incorporates them into packaging design

QUALIFICATIONS:

  • 7+ years’ experience in medical device packaging. At least 3 (possibly overlapping) years’ experience working in a clean room environment.
  • Bachelor’s degree in packaging engineering preferred. Applicants with bachelor’s degrees in other applicable fields will be considered.
  • Familiarity with ISO9001/13485 and applicable FDA documents/procedures required.
  • Thorough knowledge and significant experience regarding packaging costs. Must be able to quote competitively in the medical device market.
  • ISO 14644-1,2,3,4:2015
  • Demonstrable leadership experience and management ability.
  • Proficiency with CAD/CAM software a plus.
  • Experience in Design for Manufacturing, FMEA, DOE, and Validations
  • Working knowledge of ISO 11607, ASTM D6198 and ASTM D4169

COMPENSATION PACKAGE INCLUDES:   

Health, Dental, Vision & Life & Disability Insurance available.

Paid Holidays and PTO

Company sponsored 401K plan with generous company match

Tuition Reimbursement

Equal Opportunity/Affirmative Action Employer/Protected Veterans/Disabilities/Drug Free Workplace