NPI Manufacturing Engineer I - Medical Devices

Cook Inc - Bloomington in

Bloomington (IN)

On-site

USD 65,000 - 90,000

Full time

6 days ago

Be an early applicant

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

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.

Qualifications

Bachelor's degree in Engineering or Engineering Technology.
Experience in Class II/III medical device manufacturing.
Knowledge of process validation and lean manufacturing.
Familiarity with ISO13485/FDA GMP standards.
Proficient in MS Office; CAD tools (Creo, SolidWorks).

Responsibilities

Collaborate in a team of engineers focused on design, development, and implementation of new processes.
Execute methods for compliant, efficient process development including design for manufacturing and validation.
Utilize a risk-based approach during development, implementation and validation.
Responsible for PFMEA, production instructions, drawings and related documentation.
Coordinate transfer to manufacturing of R&D projects with cross-functional teams.
Assess make-vs-buy decisions and identify new equipment.
Work across global teams maintaining attendance and professional communication.
Promote Cook Operating System and line start-up.