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Work as part of a product development team with Siemens staff to support conceive, design, specify, develop, install, operate and parametrically characterize pilot scale manufacturing process for consumable medical diagnostic products that can be suitably scalable to meet high-volume commercial production requirements.
Key aspects will likely include exposure or ability to directly support the following objectives:
Establishing unit operations to produce prototype materials/product to support R&D efforts and parametrically analyze unit operation performance to determine key process requirements.
Participate in identifying and selecting external supply partners/equipment to establish unit operations and where applicable help establish and manage relationships with external partners.
Participate in developing cost model for fully scaled process, understand process/material cost dependencies and use that to iterate product design to optimize cost. Also develop operations model (labor, yield, throughput, scheduling, capital, space, environmental controls, etc.,) for high volume manufacturing process
Physical/chemical characterization of product, metrology, performance testing and working with team to correlate impact of process parameters on end-use product.
Development/specification of raw material materials handlers and pick and place equipment for automated feed and assembly.
Development of packaging materials and resulting process equipment (sealing, bonding, adhesives, foils, etc.,) that will environmentally and physically protect product during storage, handling and transport.
Development of/or management of external partners to produce automated process equipment including the drafting of equipment specification documents, validation and acceptance requirements for the receipt of the products
Design, specify and integrate metrology and process measurement equipment into the control system for an automated assembly process. Participate in the development of a quality control strategy for the products.
Will interact closely with the various manufacturing, quality, and corporate systems in place for efficient and effective production of diagnostics reagents geared for products supporting healthcare customers.
Essential Knowledge, Skills and Abilities, Preferred Education, Experience:
Bachelors degree is expected in Mechanical, Electrical, Chemical or Biochemical Engineering or equivalent combination of direct knowledge and experience in the field.
Applied knowledge and at least 5-10 years of direct experience preferred in the development of high volume manufacturing processes of medical consumables. Specific experiences are desired in the design of automated industrial process equipment, web or continuous substrate process development, material packaging, characterization & handling, material feeders, pick and place technology, lid sealing processes, lamination, material properties and selection, packaging processes and materials, vision systems, weigh cells, control systems, in-process inspection, testing and quality control system development.
Additional relevant technical experiences may include: design of precision aqueous/fluidic/dispensing systems precision, flex circuit substrates and metallization, adhesives, in-line surface treatments, interfacial chemistry, printing systems and electrochemistry.
Relevant work experiences may include: flexible circuit manufacturing, high volume manufacturing of medical consumables
Knowledge of and experience in materials handling (bio and chemical hazardous materials and controlled substances) is desirable. Should have a working knowledge of modern analytical tools. Should have a strong understanding of chemical and physical analytical techniques.
Knowledge and Experience:
Manufacturing of critical reagents for a regulated diagnostics industry, utilizing and authoring procedures, managing bills of materials and meeting quality system requirements.
Manufacture, support, and troubleshooting of new products.
Practical integration of products/processes into an operations environment.
The individual will be expected to understand and comply with the Quality System Regulation in order to meet all FDA, ISO and IVDD standards.
The position may be expected to develop, plan, execute, and functionally direct project(s) with complex features. Position will oversee all aspects of project work to ensure completion within expected parameters and time frame.
Results will be communicated to peers and management via standard written, oral, or visual means. Good skills are expected in: computers, customary MS Office programs, various types of communication tools.
Practical knowledge and utilization of Lean Manufacturing processes is a plus.
Position will be involved in but not limited to: preparation and validation of written standard procedures for various existing and new manufacturing process, troubleshoot performance and process deviations, and drive projects for all changes to standard procedures.
Good scientific principles and practices are expected through out, including but not limited to: documentation, statistics and statistical sampling, Design of Experiments, data analysis, technical investigations of procedures & processes and laboratory skills (operation, maintenance, & troubleshooting of analytical instruments and chemistry processes).
Position may directly/indirectly coordinate others outside of work group and will interact with scientists, engineers, and management.
Direction of Others:
Position will be as an individual contributor no personnel management experience is required, however there will be the responsibility to manage external contracted partners.
Key Working Relationships:
Primarily intra-organizational contacts with Siemens engineering, software, manufacturing and supply chain teams and relationships with external development &/or supply partners.
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