Process Development Engineer MedVenture Technology Corporation
THIS JOB HAS EXPIRED Job Requirements
Key Responsibilities Process Development for New Products Lead the identification/development/qualification of new processes, fixturing/tooling, and technologies related to new product introductions into manufacturing. Lead in the development of test and inspection plans to ensure risk mitigation and quality requirements are met. Lead in the development of required documentation for process/test validation and test/inspection instructions. Collectively work with Product Development teams to ensure quality requirements and project schedules are met. Develop and implement manufacturing processes for new products in preparation of commercial production. Determine manufacturing equipment requirements. Oversee and assist in developing new or revised production procedures. Work with other Product Development engineers to ensure that products are optimally designed for manufacturing. Assist in the development of manufacturing TCOGS for new product introductions and provide ROI analysis for capital investments. Identify and implement alternative process methods that accelerate product development teams ability in assessing new product design ideas. Develop and manage Process FMEA Support Product Launches and On-going Operations Assist in developing new or revised production processes. Provide technical support in troubleshooting and resolving manufacturing issues. Review requested process changes to ongoing manufacturing processes. Documentation Create original manufacturing procedures. Work with engineers, designers, QA and Managers to develop and document manufacturing processes and other relevant procedures. Author process qualification documentation such as TMV, IQ, OQ and PQ. Create and maintain development records for design history files. Perform other duties as assigned. Supervisory Responsibility Assign work to technicians, less experienced engineersand temporary employees as needed. Mentor less-experienced process development engineers and technicians Oversee and assist in the selection of outside vendors and consultants as required. Provide leadership and direction on project teams as it relates to the process development engineering functions. Provide leadership and direction for process and business improvements. Title Level of Activity Level of Supervision Associate Engineer Support Is a mentoree and a higher level Process Development Engineer will provide direction and review their work prior to submitting deliverables Engineer I Support Is a mentoree and a higher level Process Development Engineer will provide direction and review their work prior to submitting deliverables Engineer II Support/Lead May be a mentoree or a mentor, some activities may be performed without supervision where demonstrated capability is shown. Supervision may be required for larger more complex deliverables. Senior Engineer Lead Is a mentor, most activities are performed without supervision. May have direct report(s) Principal Engineer Lead/Consult Is a mentor, all activities are performed without supervision. May have direct report(s) Engineering Fellow Consult Is a mentor, all activities are performed without supervision. May have direct report(s) Level of Activity Support Provide support of an output or activity to a higher level Process Development Engineer Lead lead an output or activity. Support less experienced Process Development Engineers and technicians. Consult provide guidance to less experienced Engineers. REQUIREMENTS Job Experience and Education BSME (or related disciple) and experience, preferably in the medical device field. Relevant experience in lieu of a degree shall be considered on a case-by-case basis. Ability to identify, evaluate and select appropriate process technologies and equipment to manufacture medical devices. Ability to quickly create and iterate process concepts. Ability to articulate tooling and equipment design requirements. Strong technical writing ability. Manufacturing process knowledge of various polymer and metal materials; specifically in catheter assembly, laser welding and packaging. Knowledge of tooling and process to produce component parts. Understanding of various manufacturing and production monitoring techniques. Understanding of lean manufacturing. Ability to use analytical techniques such as DOE and SPC. Specialty knowledge may be required in specific instances. Job Experience Level of Experience Associate Engineer 0-2 years None to very little industry experience Engineer I 1-5 years Equivalent job experience Engineer II 6-10 years Medical device job experience Senior Engineer 11-15 years Experienced in all job requirements within the medical device industry Principal Engineer 15-20 years Experienced in a variety of disciplines within the medical device industry with broad product and clinical knowledge. Engineering Fellow 20+ years Experienced in a variety of technical disciplines within the medical device industry with broad product and clinical knowledge. Physical Demands Must perform light lifting Working in a controlled environment fully gowned Ability to work extended hours as required Ability to travel Ability to work around RF and magnetic fields.
||Jeffersonville, IN |
THIS JOB HAS EXPIRED