Manufacturing Engineer 1 - NPI

Cook Medical; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Cook Medical is seeking a New Product Introduction Engineer to design and optimize processes for manufacturing new medical devices. You will bridge Product Development to Manufacturing Engineering, Quality and Operations, evaluating Design for Manufacturability and Value Engineering options.

Lead design for manufacturing, process validation, capability studies, equipment selection, and transfer to production, with thorough PFMEA documentation and cross-functional collaboration across R&D,

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• Experience in Class II/III medical device manufacturing and process validation preferred.
• Knowledge of design for manufacturing, statistics and lean principles.
• Familiarity with ISO13485/FDA GMP environment.
• Strong analytical and problem-solving abilities.

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes for device designs.
• Execute methods for compliant process development, validation, and process capability.
• Apply risk-based approaches during development, validation, and transfer to production.
• Maintain process documentation (PFMEA, work instructions, drawings).
• Coordinate cross-functionally with R&D, Operations and Production for transfers to manufacture.

Skills

Problem solving

Communication

Team collaboration

Lean manufacturing

Analytical skills

Education

Bachelor's degree in Engineering

Tools

Creo

SolidWorks

MS Office

Visio

Job description

Overview

The New Product Introduction Engineer is responsible for the designing and optimizing of processes required to manufacture new medical devices. Identify and evaluate innovative processing options based on product attributes for products, including evaluation for Design for Manufacturability (DFM) and Value Engineering. Critical responsibility is to bridge Product Development to Manufacturing Engineering, Quality and Operations.

Overview

The New Product Introduction Engineer is responsible for the designing and optimizing of processes required to manufacture new medical devices. Identify and evaluate innovative processing options based on product attributes for products, including evaluation for Design for Manufacturability (DFM) and Value Engineering. Critical responsibility is to bridge Product Development to Manufacturing Engineering, Quality and Operations.

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 a risk based approach is applied 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.
• Compare costs and benefits when choosing product in-house or supplier selection.
• 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
• Experience working in Class II/III medical device manufacturing environment with qualification of new processes and equipment validation preferred
• 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.