New Product Introduction Engineer 2
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Overview
The New Product Introduction (NPI) Engineer 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 (PFMEAs 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
- Bachelors degree in Engineering or Engineering Technology
- Minimum of 3 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 practicesGMP 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.
Required Experience:
IC
Key Skills
- APQP
- Six Sigma
- GD&T
- Root cause Analysis
- CAD
- Project Leadership
- SolidWorks
- Mechanical Engineering
- Quality Management
- Product Development
- Catia
- Manufacturing
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
