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Company

Original Job Post

restor3d · 1 week ago

Senior Packaging Engineer

Wilmington, MA

Full-time

Onsite

Senior Level

5+ years exp

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3D Printing3D Technology

H1B Sponsorship

Hiring Manager

Jovanny Cabrera

Insider Connection @restor3d

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Responsibilities

Develop and maintain strong, internal working relationships across both North and South restor3d facilities

Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals

Prioritize and plan work activities; adapt for changing conditions

Initiation, execution, and documentation of IQ, OQ, & PQ activities

Optimization of manufacturing processes (5S) for Lean Manufacturing

Day-to-day Cleanroom packaging production support activities such as NCMRs and CAPAs

Processing of documentation change requests from originator to final approval

Writing and executing process validation plans and reports, using sound, data- & stats-supported results

Using Statistical tools for alternative material evaluations and validations projects

Support of material handling and control system

Help conduct time studies and process flow mapping

Assure compliance with the requirements set forth by US FDA QSR and ISO regulations

Interpret standards and FDA requirements for device packaging and validations.

Apply sterilization requirements/standards to packaging design and validation.

Work cooperatively with process development, quality, manufacturing, regulatory, and marketing to ensure project success.

Documentation of manufacturing processes and inspection criteria within the company’s documentation procedures

Evaluate and recommend capital equipment to best suit the needs of the company’s selected fabrication processes

Participation on project teams as a contributor bring proactive solutions and execution

Other responsibilities as assigned

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

FDA regulationsMedical devicePharmaceuticalsBiotechLife sciencesOrthopedicsCAD modelingEO sterilizationVHP sterilizationManufacturing processes documentationWork instructionsSOPsRoot cause analysisISO 13485QSR regulationsStatistical analysisISO Class CleanroomsSolidWorksProblem-solvingHard-working communication attention to detailSelf-motivationTeamworkOrganizational skillsAnalytical skillsTime-managementJust-in-time manufacturingPrototype developmentMS Word

Required

Bachelor’s Degree in Packaging Engineering required, Master of Engineering Degree strongly preferred

5-7 years previous experience in a FDA regulated industry required: medical device, pharmaceuticals, biotech, and/or life sciences; orthopedics experience preferred

Experience in CAD modeling

Experience in EO and VHP Sterilization modalities

Prior experiencing documenting manufacturing processes and creating Work Instructions and Standard Operating Procedures for a high-volume production floor

Ability to work independently as well as on teams to perform root cause analysis and provide solutions to the root cause

Excellent written and verbal communication skills

Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail

Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness

Strong organizational, analytical, and time-management skills

Able to self-motivate and work both independently and as part of a team

Understanding of ISO 13485 and QSR regulations

Knowledge of statistical analysis

Experience working ISO Class Cleanrooms or Controlled Environments

Knowledge of computer added design (SolidWorks preferred)

Preferred

Prior experience in just-in-time manufacturing or prototype development preferred

Working knowledge of MS Word, Project, PowerPoint, and Excel, AutoCAD or SolidWorks preferred

Company

restor3d

Restor3d offers surgeons with biomaterials, 3D printing technologies, and artificial intelligence to repair and rebuild the human body.

Founded in 2017

Durham, North Carolina, USA

51-200 employees

http://www.restor3d.com

H1B Sponsorship

restor3d has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (1)

2022 (3)