Process Development Engineer

Job Description

Purpose

The Process development (PD) engineer will be responsible for the Technology development phase of an RD project. They will also be part of the Product Development (PDP) team to lead all technology, manufacturing and design transfer processes and deliverables support across the PDP cycle. As TDP lead, the individual will be responsible transitioning approved project and concepts into the TDP phase. The individual will lead the technology planning, identification, testing, verification and knowledge transfer for all for all projects in the TDP phase. Overall PD engineer will be responsible for leading the Voice of Technology in a given project. The individual should be well versed with medical device technologies like molding, advanced molding like insert molding, metal injection molding, extrusion technologies, braided tubing, laser cutting and 3D manufacturing technologies. The PD engineers will also lead the development of local vendor ecosystem and suppliers of medical grade materials, tools and components. As core team member of a PDP team, the PD engineers will lead the development of manufacturing processes, verification and validation and design transfer to manufacturing. The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures. Should be comfortable working in a matrix organizational structure.

Responsibilities:

Lead the Technology development process as per Boston Scientific PLCP Establish technology development plans, goals and timelines Identify new technology platforms, evaluate existing internal technologies Establish internal and external teams and technology review board Conduct Design of Experiments and document results and recommendations. Lead technical reviews with advisory board and internal sponsors. Finalize technology plans and delivery test prototypes. Validate concepts and plan final reviews and transfer to PDP team.

Core team member of PDP team Finalize Voice of technology Link technology transfer to design input Participate in developing prototypes, process and equipment to support small and large volume manufacturing. Provide inputs to product design team and identify application standards. Participate in DOE s and maintain records. Provide inputs to product and design verification and validation plans. Lead / Co- lead process verification and validation including IQ, OQ and PQ Lead / co- lead design transfer to manufacturing. Provide sustaining support post product launch. Compile documents to meet al Quality, regulatory, PLCP based SOP requirements.

Academic Qualifications and Experience Required:

Masters (or higher) degree in engineering Mechanical or Production with specialization in one or several of the following: Plastic and metal process like extrusion, molding, sheet metal, micromachining technologies, metal insert molding, wire braiding, multi- lumen extrusions, blow molding Advance manufacturing techniques. 3D printing, metal injection molding, small volume manufacturing, soft tooling Material Science / Polymer science Experienced in Value Engineering processes. 3 - 5+ years of experience in medical device RD process and production function. Well versed with medical device quality systems based on ISO 13485. Preference for candidates with PMP certification or similar project management training and experience Sound understanding of medical device regulatory requirements for Class II and III medical devices will be preferred. Proficient in project management tools like MS project. Skilled in implementing tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). Past experience as a design engineer will be an added advantage. Well versed with CAD CAM tools on platforms like Solidworks, CFD, Ansys, Abacus. Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB. Project planning resourcing, timelines, quality and budgets. Experienced in Process based work culture Excellent Communication, presentation and interpersonal skills with proficiency in English (verbal and written). A positive attitude, innovative and creative thinker. Responsible risk taking and risk management. Experience in working with global and virtual team and working in a cross cultural environment.

Keyskills :
cadcam designofexperiments projectmanagementtraining sheetmetal core fanuc productdesign continuousimprovementfacilitation riskmanagement classii 3dprinting blowmolding troubleshooting processengineering sixsigma lasercutting metalinjectio