Senior Specialist, Design Transfer

Abbott • South Portland, ME

6h • $78,000 - $156,000 • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. This position works on site daily out of our South Portland, Maine location in the Abbott Rapid Diagnostics Infectious Diseases group . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. As the Senior Specialist, Design Transfer , you’ll have the chance to be responsible for all activities associated with the transfer of one or more new products from R&D in Operations and oversee the completion of commercialization activities to achieve the launch of new products. In addition:

Requirements

• Bachelor's Degree Discipline appropriate to the project.
• Able to effectively manage and lead complex projects.
• Has led the transfer of at least one significant project.
• Must have demonstrated working knowledge of regulations and standards affecting IVD products and have experience with products under design control.
• Requires a demonstrated high level of independence and excellent interpersonal and communication skills.
• Minimum 5 years Relevant experience in medical device manufacturing industry

Nice To Haves

• Master's Degree or PHD in similar field of expertise

Responsibilities

• Independently manage the transfer of complex large projects, or several smaller projects of low or moderate complexity.
• Expedite, manage, and coordinate a multitude of interrelated activities including other functional requirements within the constraints of limited human and financial resources and changing priorities.
• Participate in identifying project funding needs.
• Provide leadership and subject matter expertise to product development team to ensure product design is manufacturable.
• Creates and gains approval of device master record documents required to manufacture and test the product, including packaging, labeling, and new raw materials.
• Act as the key liaison between R&D and Operations areas.
• Communicates and works with Planning to schedule verification and validation lots and initial lots to stock.
• Follow change control process to assess and implement changes to DMR documents during product development.
• Create and approve Design History File deliverables associated with product transfer.
• Complete transfer activities required for product commercialization.
• Facilitates discussions and manages the commercialization of TPM manufactured materials required for the product.
• Works with R&D and Operations to develop and implement a manufacturing validation strategy and address equipment, process, and test method validations required for product transfer.
• Writes and oversees execution of validation master plan.
• Recognizes strategy, evaluates risks, recommends actions and develops contingencies to address various scenarios.
• Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.
• Anticipate future problems, resolve current issues and adjust based on prior results
• Works with members of cross-functional project team to gather input, coordinate activities, and complete product transfer activities.
• Solicit the cooperation of cross-functional team members in a tactful and persuasive manner.
• Accountable for achievement of goals for assigned new product development projects.
• Accountable for the successful completion of project tasks on time
• Prepare and present written and oral reports and other presentations to internal and external audiences as required.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level