Risevoic
New Product Introduction Engineer 2
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 11 January 2026
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 (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 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 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.
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Frequently asked questions
Mastery in process validation, lean manufacturing, and design for manufacturability (DFM) stands out for this role. Additionally, familiarity with medical device quality standards like ISO 13485 and FDA regulations ensures compliant and effective product introductions.
This position bridges design and manufacturing by optimizing production processes, validating equipment, and ensuring risk management. The engineer collaborates closely with R&D and operations to ensure smooth transfer, reducing defects and ramp-up time for new medical devices.
Progression often leads to senior engineering roles, product management, or operations leadership within medical device companies. Skills in process optimization and cross-functional collaboration open doors to strategic roles in manufacturing innovation and quality assurance.
Certifications such as Six Sigma Green Belt, Lean Manufacturing, and ASQ Quality Engineer are highly regarded locally. They demonstrate expertise in process improvement and compliance, aligning well with Cook Medical’s quality-driven culture.
Cook Medical is a prominent player offering comprehensive benefits and innovation-focused projects, making its NPI roles highly sought after. Candidates often face competition from other regional medical device firms, but Cook’s reputation for integrated manufacturing offers a distinct advantage.
Cook Medical emphasizes integrated manufacturing and quality at source, requiring strong collaboration across global teams. The role demands agility in managing complex regulatory requirements alongside rapid process development to meet evolving device designs.
Travel is minimal, typically up to 10% overnight trips, mainly for supplier or facility visits. The role is predominantly on-site due to hands-on equipment validation and close collaboration with manufacturing teams, reflecting the company’s focus on operational excellence.
In Bloomington, New Product Introduction Engineers at level 2 generally earn between $75,000 and $95,000 annually. Salaries reflect the specialized medical device sector demand and Cook Medical’s competitive compensation aligned with experience and skills.
Bloomington’s collaborative and innovation-driven culture fosters teamwork and continuous improvement. Engineers are encouraged to engage cross-functionally, blending technical expertise with practical manufacturing insights to support Cook Medical’s product launch success.
Prioritize early risk assessments and maintain clear process documentation to avoid delays. Engaging with R&D and production engineering teams regularly helps anticipate challenges, ensuring smoother equipment qualification and faster production ramp-up.