Principal Process Engineer

DO WORK THATMATTERS.

At Abbott, diverse ideas, perspectives,and expertise allow us to create the life-changing solutions that help peoplelive healthier lives. In 150 countries and with businesses spanning nutrition,diagnostics, medical devices, and branded generic pharmaceuticals, Abbottoffers you enormous opportunities to explore your interests and help youachieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family ofbusinesses, bringing together exceptional teams of experts and industry leadingtechnologies. We have an exciting opportunityfor a Principal R&D Process Engineer within our Infectious Disease Developed Markets located at Scarborough, ME. In thisrole, you will be instrumental in the influence of excitingnew product design teams to introduce them into the lean manufacturingenvironment.

Job Summary

This position is responsiblefor timely introduction of new products into the manufacturing environmentwhile ensuring the highest levels of quality. This person will influence newproduct design teams to improve design for manufacturability, as well asdefine, validate and implement processes to support the introduction of newproducts into a lean manufacturing environment.

Description

The R&D Process Engineer manages a wide variety of technical tasks andprojects in the development of new products and manufacturing processes. Thisindividual will be a technical leader within the R&D team and a key memberof the medical device product development teams.

* Contribute directly to the development of new productconcepts, processes, and techniques to ensure that products meet customer'sneeds and are high quality and low cost.

* Serve as a technical interface within Alere between theManufacturing and Materials, R&D, Quality, Regulatory, and Marketingorganizations.

* Manage/hands-on design and development of new productsand processes as well as product changes and enhancements. S/he willdemonstrate knowledge to chemistry, plastics, molded and machine part design asper program requirements.

* Work closely with external partners to transfer newmaterials and mechanical products to manufacturing. This person will plan,schedule and complete the DFM projects as per the program timelines.

* Will possess a working application/knowledge of medicaldevice regulatory requirements and standards.

* Write phase review updates and reports for designverification/process validation, complete testing, and transfer tomanufacturing. Including Manufacturing Process Instruction (MPI), Lot HistoryRecord (LHR), Bill of Material (BOM) and other production documentation.

* Lead and directly participate in the design and testingof manufacturing fixtures and equipment.

* Directs DFM activities within the R&D program team.

* Lead and be responsible for the design transfer intooperations

DesiredSkills and Experience

* The ability to manage resource, time, budget, and peopleare required. This person must have the ability to work cross-functionally withteams.

* Proven application of statistical techniques, Design ofExperiment (DOE), and Design for Manufacturing (DFM) experience is preferred.

* Knowledge of and compliance with applicable QualitySystem requirements (e.g., FDA, ISO & MDD) and experience working in aregulated environment is preferred.

* Strong written and verbal communication skills tocommunicate effectively at all levels are required.

* Good presentation skills to deliver updates and/orpresentations effectively to a variety of audiences are required.

* Able to influence and manage at all levels

* Proficiency with MS Word, Excel and Project is required. Experiencewith CAD, preferably SolidWorks is preferred.

* This position is based in Scarborough and may require upto 20% travel Domestic and International.

Minimum Qualifications

Education

Bachelor's degree in chemistry, manufacturing engineering, mechanicalengineering or industrial engineering preferred.

* Minimum of 8 years' experience in new product introduction of Medical Device Products.

* The ideal candidate will have a minimum of 8 years ofdemonstrated medical device R&D and manufacturing in a directly relatedfield.

* Excellent conceptual, analytical, and problem-solving ability.

* Experience with Design for Manufacturability and Assembly (DFMA).

* Excellent computer skills – Minitab, Jump, CAD, word processing, and spreadsheets.

* Good communication skills, both verbal and written, and the ability to effectively interface within a cross-functional team environment.

* Experienced in modern manufacturing principles and techniques.

Preferred Qualifications

* Knowledge and experience in CGMP requirements and preferably FDA and ISO 9000 requirements.

* Six Sigma/DFM/Black belt experience