Labeling Engineer

Job Title: Labeling Engineer

Location: Milpitas, California (Onsite role)

Duration: 6 Months

Only W2 candidates are considered.

About the Role

• Manage / lead / execute labeling project(s) involving NPD and current commercial products.
• Create / update the label artworks, label specifications, user manuals and its specifications and all other associated manufacturing instruction documents.
• Providing input to the offshore team to execute their tasks as per customer guidance / process / procedure.
• Create / update the design control documents, Bill of materials, drawings & other support documents and review of these documents from R&D’s technical specialty.
• Create / update the labeling design specification documents including artworks using graphic designing tools.
• Update the labels and user manuals as per EUMDR requirements
• Manage transactions in Product Lifecycle Management tool & review and update Bill of Materials.
• Create / Update Standard Operating Procedures & Manufacturing Work Instructions.
• Need to handle change control management activities in PLM tools.
• Accountable to initiate, plan and drive multiple projects throughout the project lifecycle.
• Follow-up with Work Stream Leads from Manufacturing Plants and cross functional teams to assimilate project information daily.
• Accountable to drive projects through planning, execution and close out phases.
• Accountable for project communication with teams, peers, and leadership.
• Manages project(s) risks and issues proactively.
• Knowledgeable with problem-solving skills, able to find innovative ways to resolve issues.
• Knowledgeable on EUMDR, 21CFR 820, ISO 13485, ISO 14971, ISO 15223, EN 1041 & ISO 20417.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Mechanical engineering or equivalent; Master’s degree preferred.
• Minimum 5 years of industry experience with medical device labeling projects.
• Experience working in a highly regulated industry (e.g., medical device, pharmaceutical) including hands-on experience in a medical device design control process.
• Knowledgeable of medical device quality systems, FDA, EUMDR and applicable ISO standards.
• Knowledge and hands-on experience in EU MDR related projects are an advantage.
• Experience with problem solving methodologies.

EDUCATION and/or EXPERIENCE

• Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering
• 5 Years of medical/ pharmaceutical packaging design and development experience

LANGUAGE SKILLS

• Must be able to speak and write English fluently; must be able to communicate clearly and accurately.

Must be able to understand legally and technically written standards, regulations, and procedures.