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Packaging Engineer

1 month ago

Boston, United States Practical Applications Full time
Packaging Engineer

We Deserve the Best – And So Do You

High Growth Company

Opportunity to Learn and Grow

Shape your Career

See the Importance of Your Work

Millstone Medical Outsourcing is looking for an energetic individual to join its Engineering Department as Packaging Engineer. Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

SUMMARY:

The Packaging Engineer will support multiple concurrent projects and is responsible for packaging configurations and processes related to new product launch, existing packaging improvements, and line extensions. This includes evaluating packaging configurations for feasibility in relation to validation (ISO 11607) and commercial success during Millstone’s launch process. The Packaging Engineer will manage Millstone’s Fastlane Packaging to support new programs while continuously evaluating the Fastlane strategy to stay competitive in the industry. Additionally, this role will work cross functionally to support Millstone’s operations team with packaging related trouble shooting and cost reduction projects.

RESPONSIBILITIES:

  • Extensive Experience with sterile barrier packaging system designs consisting of sterile pouch and thermoformed tray packaging.
  • Experience with Package Design Verification and Validation including Packaging Usability, Design Verification and Validation, Transportation and Handling testing, Package quality including sterile barrier testing (ISO 11607)
  • Demonstrated experience with material, equipment, and process validation according to medical device and pharmaceutical industry standards.
  • Experience with Thermoforming, Heat Sealing, Impulse Sealing, Vacuum Flush Pouching, Cartoning, and label printing/ verification.
  • Sterilization packaging processes such as aseptic filling and packaging for terminal sterilization using autoclave, VHP, EtO, Gamma, etc.
  • Possess the ability to be actively involved in trouble-shooting packaging and process problems, coordinating with internal and external teams and resources.
  • Able to guide others in the use of test equipment/tooling/processes.
  • Ability to troubleshoot equipment.
  • Ability to read and interpret schematics and detailed mechanical drawings.
  • Basic math through Calculus
  • Intermediate skills in Statistics
  • Ability to interact with all levels of the facility
  • Ability to interact with clients and interpret their needs
  • Ability to negotiate with clients regarding projects, timelines, and processes
  • Escort vendors within facility and provide technical expertise as needed
  • Ability to work and interact in a team environment
  • Ability to perform detailed engineering work without supervision
  • Get the job done attitude
  • Able to meet or exceed established commitments
  • Willingness to do what needs to be done to meet customer needs/timelines
KNOWLEDGE & SKILLS REQUIRED:
  • Bachelor’s degree in Engineering / Packaging Technology
  • 1 year relevant experience
  • Technical writing proficiency to develop client process validations
  • Excellent communication skills
  • Excellent attention to detail, analytical and problem-solving skills
  • Experience with IQ, OQ and PQ protocols
  • Knowledge of GMPs


ADDITIONAL INFORMATION:

Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay, tuition reimbursement and may other voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing’s opportunities, please visit us online at www.millstonemedical.com.

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.