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Zeus · 1 month ago

CathX Senior Manufacturing Engineer

Arden Hills, MN

Full-time

Onsite

Senior Level

$113K/yr - $136K/yr

5+ years exp

Zeus is the world’s leading polymer extrusion manufacturer and material science innovator. The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices, while also providing technical expertise to resolve issues and maintain production efficiency.

ManufacturingPlastics and Rubber Manufacturing

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Provide technical support for day-to-day manufacturing line operations, troubleshooting equipment and process issues

Implement and lead continuous improvement projects to enhance productivity, quality, and cost-effectiveness

Lead process validation activities (IQ/OQ/PQ) in compliance with regulatory requirements

Manage line transfer projects, ensuring smooth transition and qualification of equipment and processes

Apply structured problem-solving methodologies (e.g., 5 Whys, Fishbone, DMAIC) to identify root causes and implement effective corrective and preventive actions (CAPA)

Design tools and machines used to manufacture medical products

Review production program equipment, hardware, and tooling; make recommendations for servicing, specific repairs or replacement

Develop and optimize manufacturing processes for scalability, efficiency, and quality

Install new equipment and ensure correct operation; train others to operate new machinery

Maintain a general knowledge of new and developing manufacturing technology, equipment, and applications; apply this knowledge to recommend and implement new technology and processes

Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

Perform other duties assigned as needed

Qualification

Medical device manufacturingCAD software (AutoCAD/Solidworks)Process validation (IQ/OQ/PQ)Statistical analysisLean Manufacturing/Six SigmaThermoplastic materials knowledgeManufacturing ProcessCommunication skillsProblem-solving techniquesWork independentlyTechnical leadership

Required

Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering or equivalent experience based on management discretion is required

Must have five (5) plus years' relevant Engineering experience

Knowledge and experience in medical device manufacturing is required

Competent experience with CAD software such as AutoCad or Solidworks is required

Knowledge and experience in development processes and in medical product documentation writing is required

Ability to use PC and associated software is required

In-depth knowledge of thermoplastic materials and metals is required

Knowledge of Good Manufacturing Process and Good Documentation Practice

Preferred

Master's Degree in Mechanical Engineering, Industrial Engineering, or Biomedical Engineering is preferred

Catheter experience preferred

Experience with statistical analysis and design of experiments (DOE) preferred

Lean Manufacturing or Six Sigma certification or experience preferred

Benefits

Competitive pay

Great benefits package

Company

Zeus

Delivering dependable and innovative polymer solutions for over 50 years.

Founded in 1966

Orangeburg, South Carolina, USA

1001-5000 employees

http://www.zeusinc.com

H1B Sponsorship

Zeus 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

2023 (1)

2022 (1)