Title: Senior Machine Design Engineer
Location: US-Massachusetts-Billerica
Job Number: MAN10329
PURPOSE & OBJECTIVE
This role will report to the Engineering Manager and support the BD-Diabetes Care Infusion Platform product launches utilizing the BD Produce Development System (GPDS). The position will function as the machine design engineer responsible for supporting a new insulin delivery system project in collaboration with the lead automation engineer. The role includes two major areas of responsibility: process design through prototype and scale-up to full production; and, responsible for current assembly automation process optimization to improve quality, productivity and cost.
Process Design: Responsible fordesigning machinery that is moderate to complex in scope using a variety of engineering principles from mechanical, electrical, or other engineering disciplines. Prototype machine design and build is necessary to support the manufacturing feasibility analysis for assembling the new insulin delivery product. Responsible for realizing unique manufacturing processes, performing risk assessments, and establishing process requirements. Carry ideas through concept development, mechanical design, parts detailing, and fabrication / build for new assembly fixtures, automation, and test equipment.
Process Improvement: Responsible for supporting the optimization of current assembly processes throughcontinuous improvement initiatives by making improvements to existing machines and designing new equipmentto improve current processes. Provides support related to capacity expansion projects, projects to improve product and process robustness, and troubleshooting / technical support forexisting equipment.
ESSENTIAL JOB FUNCTIONS
1. Process Design:
Key duties and responsibilities include:
ú Develop process requirements / flow for product assembly as required.
ú Creates designs by analyzing product designs, equipment specifications, performance requirements, and previous designs of similar equipment; review and identify applicable novel or existing processes performing the necessary risk assessment.
ú Develops data and prepares preliminary layouts, sketches, notes, and documentation to support the reviewed designs to convey intent.
ú Performs moderate to complex design and evaluation of mechanical or electromechanical components, subsystems, and systems by applying engineering principals and established analytical tools.
ú Investigates pertinent design factors such as safety, ease of manufacture, availability of materials and equipment, ease of maintenance, strength-weight efficiency, etc.
ú Develops final machinery layouts, detailed drawings, assembly drawings, and schematics using computer-aided design tools and following conventional and company drawing standards.
ú Perform process capability and scalability analyses.
ú Design, fabricate, debug, install, and evaluate manufacturing process prototype equipment and tooling for process feasibility evaluation.
ú Identify and work with outside partners for manufacturing process and equipment design.
ú Develops standard operating procedures as required.
ú Design and execute experiments using Six Sigma methodologies and analyze test results using statistical tools.
ú Develop specifications for automation hardware, operating procedures; inclusive of timing charts.
ú Maintain documented records required for design and change control practices.
ú Set, implement and maintain schedules to ensure project completion meets deadline.
ú Performs other related duties and assignments as required.
2. Process Improvement:
Key duties and responsibilities include:
ú Work with plant engineering and support the troubleshooting and technical challenges on existing manufacturing equipment.
ú Support the company’s safety and continuous improvement initiatives by making improvements to existing machines and designing new equipment with an emphasis on machine guarding, ergonomics and human factors to improve current equipment and integrate into new and in-process machine designs
ú Work with cross-functional teams that support Lean Six Sigma/continuous improvement initiatives
ú Designing and detailing modifications to existing equipment to increase efficiency and improve yield.
ú Ability to effectively apply continuous improvement principles and techniques to design and manufacturing areas.
ú Seek equipment improvement opportunities that are not within the original scope of projects (continuous improvement) on a routine basis
ú Specify equipment, tooling and fixtures for new processes and process changes.
ú Support vendor and technology selection processes for automation development activities.
ú Author and execute process development protocols in accordance with QA and regulatory requirements.
ú Performs other related duties and assignments as required.
Qualifications:
MINIMUM QUALIFICATIONS
Education: B.S. degree in Mechanical Engineering or related discipline is required. BD operational experience preferred.
Experience: The candidate is expected to have a minimum of 5-7 years relevant experience, and knowledge in the fields of automation engineering and process automation.
KNOWLEDGE, SKILLS, AND ABILITIES
Organizational:
ú The incumbent has experience in Drug and Medical Device manufacturing environments and has worked within regulated industries.
ú The incumbent must be highly motivated with good organizational and analytical/technical problem solving skills.
ú The incumbent must be a self starter with capability of working under minimal supervision.
ú The incumbent has effective written and oral communication skills; capable in communicating to multiple audiences, and senior management personnel.
ú The incumbent has meaningful experience with and strong capability to work well in a team based environment and promote teamwork.
ú The incumbent has effective organization, project management, time management, and planning skills.
ú The incumbent has very strong and effective interpersonal skills with the ability to develop others.
Technical:
ú The incumbent must have experience with fixture design or prototype automation machine design; machine shop experience preferred.
ú The incumbent must have practical knowledge offirst principles modeling / theoretical engineering; inclusive of mechanical engineering principles, theories, concepts, and techniques, industry practices, regulations, and policies.
ú The incumbent must have fundamental understanding of statics, dynamics and stress analysis; materials selection and manufacturing methods.
ú The incumbent must have knowledge of drawing practices, tolerancing and use of computer-aided design, drawing management tools, and basic engineering analysis tools.
ú The incumbent must have experience in development and troubleshooting of machine and process operations for complex automation and assembly, including packaging.
ú The incumbent must have experience in the specification and design of automated manufacturing equipment and processed for use within a regulated industry.
ú The incumbent has experience with managing 3rdparty vendors, suppliers and technical development processes.
ú The incumbent has experience with operation of PLC (Programmable Logic Control) machines.
ú The incumbent has experience with First of Type” automation, from pilot line design to full production scale-up.
Functional:
ú The incumbent must have 3D modeling skills: Solidworks, AutoDesk Inventor, and ProE preferred.
ú The incumbent must have Six Sigma proficiency, Black Belt, Green Belt or DFSS preferred.
ú The incumbent must be hands on and have experience with proof of principle work in the lab or similar environment.
ú The incumbent has experience with DFX (Manufacturing, Assembly, and Molding).
ú The incumbent has computer skills in Microsoft Office.
Job: Manufacturing Engineering
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BDdashDiabetes
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Senior Machine Design Engineer