Principal / Sr Product Engineer - Catheter Processing MedVenture Technology Corporation
Lead the identification/development/qualification of new processes, fixturing/tooling, and technologies related to new product introductions into manufacturing.
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.
Work with Design Engineering in the selection of materials and device designs.
Collectively work with Product Development teams to ensure quality requirements and project schedules are met.
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.
Assist and/or perform design verification and validation testing to include protocol development and testing.
Lead effort and apply expert knowledge in the intellectual property position of the company via invention and patent applications.
Maintain current expert knowledge of competitive technologies in the medical device industry.
Identify and implement alternative process methods that accelerate product development team?s ability in assessing new product design ideas.
Develop and manage Process FMEA
Lead and develop the Process Validation Plan (PVP)
Responsible to ensure process stations are capable of repeatable outputs (measured through yield requirements)
Support Product Launches through transfer to sustaining manufacturing including the developing new or revised production processes; provide technical support in troubleshooting and resolving tooling & equipment issues and ensure process stations meet or exceed the required cycle time to meet initial production forecast
Train technicians on manufacturing processes in conjunction with the operations team through product launch.
Create original manufacturing procedures along with process qualification documentation such as TMV, IQ, OQ and PQ.
Create and maintain development records for design history files.
Bachelor of Science degree in Mechanical Engineering (or related disciple) and experience, in the medical device field.
10+ years of process development and new product transfers/launches/introductions, prototyping capability is preferred
Ability to identify, evaluate and select appropriate process technologies and equipment to manufacture medical devices, preferably minimally invasive and catheter based technologies.
Manufacturing process knowledge of various polymer and metal materials; specifically in catheter assembly, laser processing and packaging.
Experience with Electrophysiology (EP) Systems
Ability to quickly create and iterate process concepts using a hands-on approach.
Knowledge of tooling and processes to produce component parts. Advantageous to have specific experience in balloons, extrusion, endovascular delivery systems or related technologies.
Ability to articulate tooling and equipment design requirements. Hands on tooling design a plus.
Strong technical writing ability.
Understanding of various manufacturing and production monitoring techniques.
Understanding of lean manufacturing and use of analytical techniques such as DOE and SPC.
Leadership ability and organizational skills
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab.
Applied Statistics knowledge
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates
Ability to lead smaller teams of 2-4 members
Execute tasks in a timely manner without direct supervision.
Able to prioritize tasks.
||Minnetonka, MN |