Manufacturing Engineer 1 - NPI

Cook Medical; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Cook Medical in Bloomington, IN seeks a Manufacturing Engineer 1 for New Product Introduction. You will design and optimize processes to manufacture new medical devices, bridging Product Development to Manufacturing, Quality and Operations.

You will lead design-for-manufacturing activities, develop validations, and document PFMEAs, Instructions, and drawings, collaborating with R&D, operations and production engineering to transfer projects to manufacturing.

Qualifications

• Bachelor’s degree in Engineering or Engineering Technology.
• Experience in Class II/III medical device manufacturing and process validation.
• Knowledge of ISO13485/FDA GMP and related standards.
• Strong analytical and problem-solving abilities.
• Proficiency with Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project).
• Prefer Creo or SolidWorks for 3D modeling.
• Experience with design for manufacturing and lean principles.

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes.
• Perform design for manufacturing, process validation, and process capability work.
• Apply risk-based approaches during development, validation, and transfer to manufacturing.
• Maintain process documentation (PFMEA, production instructions, drawings).
• Coordinate with R&D, Operations, and Production engineering for transfer to manufacturing.
• Evaluate in-house vs supplier options to optimize costs.
• Define and procure new equipment for manufacturing processes.
• Ensure projects meet timelines and performance expectations.
• Communicate effectively across levels of the organization.
• Support line start-up and training; promote integrated manufacturing and quality at source.

Skills

Process validation & DFM

Lean manufacturing

Analytical problem solving

Communication skills (oral/written/ppt

Microsoft Office Suite

3D modeling software

Education

Bachelor’s degree in Engineering or Engineering Technology

Tools

Creo

SolidWorks

MS Project

Excel

Visio

PowerPoint

Job description

Manufacturing Engineer 1 - NPI

Job Location(s): Bloomington IN United States

Job Locations: US-IN-Bloomington

Position Type: Full Time

Company: Cook Inc - Bloomington

Category: Engineering

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.

“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.” Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.