Process Engineer

Duties & Responsibilities

• Prepares and submits ECOs to include: new and/or updated Work Instructions (WI), Bill of Materials (BOMs), Manufacturing Specification (MS), and routings.
• Create SAP label templates, test and implement UDI/Label changes for reagent and OEM products.
• Work in SAP and other document archives to gather and review available documentation. Retrieve, compile, and summarize manufacturing data to perform label and UDI gap analysis.
• Cook up with Planning and Manufacturing to ensure manufacturing readiness of phase out/phase in product versions in the implementation of labelling and packaging changes until products are in inventory.
• Perform other tasks as assigned to support UDI, IVDR and Reagent Operations.
• Promotes a safe work environment.

Minimum Qualifications

• Requires a minimum of a Bachelor’s degree in biological sciences with 1 year of relevant experience in a manufacturing or laboratory environment or related business/industrial experience.
• Experience in an FDA or ISO regulated medical device production environment.
• Knowledge of medical device documentation, product labeling, reagent manufacturing, and business process are desirable
• Experience in document creation, BOMs, Routings, etc
• Experience in SAP is highly preferred

Skills / Experience

• Knowledge of general laboratory safety, GMP's and associated regulatory requirements
• General knowledge of Microsoft Word and Microsoft Excel
• Redlining experience
• SAP
• Requires good documentation (maintaining clear and concise records) and effective communication
• The preferred candidate will demonstrate excellent organizational skills, and the ability to manage multiple/changing priorities and effectively work in a team environment
• Ability to read, write, interpret, and comprehend specifications and perform basic math calculations
• Has good attention to detail
• Ability to get along with people and be able to work in a team environment