Manufacturing Engineer 2 - NPI

americas-cookmedical; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Cook Medical is seeking an NPI Engineer 2 to bridge Product Development into Manufacturing Engineering, Quality and Operations. You will configure and optimize processes for manufacturing new medical devices and support DFx and value engineering initiatives.

You will collaborate with R&D, Operations and Production to transfer projects to manufacturing, qualify new processes, and help ensure on-time, compliant execution across the Cook Operating System framework.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• Minimum 2+ years in Class II/III medical device manufacturing with qualification of new processes and equipment validation.
• Knowledge of process validation, design for manufacturing, statistics, and lean manufacturing.
• Experience with medical device quality standards ISO13485/FDA GMP and similar regulated standards.
• Analytical skills and problem solving.
• Proficiency with Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project).
• Experience with 3D modeling software (Creo, SolidWorks).

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes.
• Execute methods for compliant, efficient process development (DFM, validation, capability, lean, equipment specs).
• Apply a risk-based approach during development, implementation, and validation.
• Maintain process documentation (PFMEA, Production Instructions, Drawings).
• Coordinate transfer to manufacturing of R&D projects with cross-functional teams.
• Define and procure equipment for manufacturing processes.
• Support line start-up, training, and continuous improvement.
• Travel up to 10% may be required.

Skills

Analytical skills

Problem solving

Communication skills

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Microsoft Office

Visio

PowerPoint

MS Project

Creo

SolidWorks

Job description

Overview

The New Product Introduction (NPI) Engineer 2 will bridge Product Development into Manufacturing Engineering, Quality, and Operations. They will be responsible for configuring and optimizing of processes required to manufacture new medical devices. Additionally, identify and evaluate innovative processing options based on product attributes, including evaluation for Design for Manufacturability (DFM) and Value Engineering.

Responsibilities

• Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Cook Inc Facilities) required for the manufacture of new device designs.
• Execute methods needed for compliant, efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development).
• Utilize and apply a risk based approach during the development, implementation, and validation of all processes.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products.
• Collaborate with R&D team, Operations, and Production engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project / objective.
• Advice new product development team on making vs. buying decisions for components.
• Define, identify, and procure new equipment for manufacturing processes.
• Ability to complete projects within specific time lines and meeting performance expectations.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Maintain regular and punctual attendance.
• Must have effective oral, written and presentation communication skills.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.
• Represent Operations Principles of the Cook Operating System.
• Champion line start up, support, and training.
• Promote and driven integrated manufacturing, driving quality at source.

Qualifications

• Bachelor's degree in Engineering, or Engineering Technology
• Minimum of 2+ years experience working in Class II/III medical device manufacturing environment with qualification of new processes and equipment validation
• Knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
• Knowledge of medical device quality standards ISO13485/FDA practices,GMP and similar regulated industry standards.
• Experience using analytic skills and problem solving
• Working knowledge of Microsoft Office Software (ie Word, Excel, Visio, Power point, MS Project)
• Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)

Physical Requirements:

• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Frequently required to sit, stand, walk, and communicate
• Must be able to perform the essential functions of the job, with or without reasonable accommodations.
• Ability to travel over-night up to 10% of time, if needed.