New Product Introduction Lead
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POST DATE 9/16/2016
END DATE 12/3/2016
JOB DESCRIPTIONJOB SUMMARY
Alere's Active Consumables Transfer Program Lead is responsible for timely introduction of new products into the manufacturing environment while ensuring the highest levels of quality. This person will influence new product design teams to improve design for manufacturability, as well as define, validate and implement processes to support the introduction of new products into a lean manufacturing environment.
The ACT program lead, manages a wide variety of technical tasks and projects in the development of new products and manufacturing processes. This individual will be a leader within the ACT team and a key member of Alere medical device product development teams.
* The ACT program lead will contribute directly to the development of new product concepts, processes, and techniques to ensure that products meet customers needs and are high quality and low cost.
* This individual will serve as a technical interface within Alere between the Manufacturing and Materials, R&D, Quality, Regulatory, and Marketing organizations.
* S/he will manage/hands-on design and development of new products and processes as well as product changes and enhancements. S/he will demonstrate knowledge to chemistry, plastics, molded and machine part design as per program requirements.
* S/he will work closely with external partners to transfer new materials and mechanical products to manufacturing. This person will plan, schedule and complete the DFM projects as per the program timelines.
* S/he will possess a working application/knowledge of medical device regulatory requirements and standards.
* This individual will write phase review updates and reports for design verification/process validation, complete testing, and transfer to manufacturing. Including Manufacturing Process Instruction (MPI), Lot History Record (LHR), Bill of Material (BOM) and other production documentation.
* S/he will lead and directly participate in the design and testing of manufacturing fixtures and equipment.
* S/he directs DFM activities within the R&D program team.
* S/he will lead and be responsible for the design transfer into operations
Bachelor's degree in chemistry, manufacturing engineering, mechanical engineering 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 of demonstrated medical device R&D and manufacturing in a directly related field.
* 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.
* The ability to manage resource, time, budget, and people are required.
* Must have the ability to work cross-functionally with teams.
* Knowledge of and compliance with applicable Quality System requirements (e.g., FDA, ISO & MDD) and experience working in a regulated environment is preferred.
* Strong written and verbal communication skills to communicate effectively at all levels are required.
* Good presentation skills to deliver updates and/or presentations 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. Experience with CAD, preferably SolidWorks is preferred.
* This position is based in Scarborough and may require up to 20% travel Domestic and International.
* Knowledge and experience in CGMP requirements and preferably FDA and ISO 9000 requirements.
* Six Sigma/DFM/Black belt experience
* Proven application of statistical techniques, Design of Experiment (DOE), and Design for Manufacturing (DFM) experience is preferred.