Manufacturing Engineer 1 jobs in United States
cer-icon
Apply on Employer Site
company-logo

Cook Medical · 2 weeks ago

Manufacturing Engineer 1

Cook Medical is focused on manufacturing custom, plastic components for medical devices. The Manufacturing Engineer 1 provides technical support for production activities, collaborating with various teams to resolve issues and drive continuous improvement.

HardwareManufacturingMedical Device
check
H1B Sponsor Likelynote

Responsibilities

Provides process support for extrusion department
Hands-on position with visibility on the manufacturing floor
Requires a high level of interaction with the production, product development, and quality teams
Supports product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives
Supports production departments’ manufacturing issues with technical support as the process expert. Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence
Supports and drives continuous improvement activities in the manufacturing department to improve operational performance. Leads technical aspect of process validation projects
Assist product development teams with design for manufacturability requirements on new products. Supports new capital equipment and tooling purchases with appropriate documentation and evaluation
Manages multiple technically oriented projects through coordinating internal and external resources
Collaborates on product complaint resolution

Qualification

Extrusion process developmentProcess validation IQProcess validation OQProcess validation PQEquipment qualification IQEquipment qualification OQEquipment qualification PQISO 13485 2016Design of Experiments / Six SigmaMechanical aptitudeTroubleshooting skillsBlueprint readingMicrosoft OfficeCFRFDAOSHA regulationsProblem-solving skills

Required

High School Diploma with applicable experience is required; Bachelor's degree in Engineering/Plastics Engineering preferred
3+ years of extrusion process development experience
Fundamental understanding engineering principles
Extrusion process development / Extrusion Tooling Design
Proficiency at using Microsoft Office applications
Troubleshooting and problem-solving skills

Preferred

Bachelor's degree in Engineering/Plastics Engineering
5+ years of work related to polymer processing
Process validation (IQ, OQ, PQ)
Equipment qualification (IQ, OQ, PQ)
Mechanical aptitude
Understanding of ISO 13485:2016
CFR, FDA, OSHA, environmental regulations
Equipment / process troubleshooting
Experience with blue print reading
Design of Experiments / Six Sigma

Benefits

Company-sponsored 401(k) and profit-sharing plan
Paid time-off benefits
Medical, prescription drug, dental and vision insurance
Flexible spending accounts including both healthcare and dependent care
Short and long-term disability
Life insurance
Well-being resources to support physical, emotional and financial wellness
Comprehensive EAP program
Voluntary benefits funded 100% by employees in the areas of critical illness, accident insurance, hospital indemnity and long-term care

Company

Cook Medical

company-logo
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.

H1B Sponsorship

Cook Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)

Funding

Current Stage
Late Stage

Leadership Team

G
Gayle Cook
Co-founder
leader-logo
Kelly Fischer
Senior Vice President and Chief Financial Officer
linkedin
Company data provided by crunchbase