CathX Sr Mfg Engineer

Zeus•Arden Hills, MN

17d•$113,000 - $136,000

About The Position

The Senior Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. Additionally, the engineer supports daily manufacturing operations in a sustaining role, providing technical expertise to resolve issues and maintain production efficiency. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering or equivalent experience based on management discretion is required. Master's Degree in Mechanical Engineering, Industrial Engineering, or Biomedical Engineering is preferred. Must have five (5) plus years' relevant Engineering experience Knowledge and experience in medical device manufacturing is required. Catheter experience preferred. 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. Experience with statistical analysis and design of experiments (DOE) preferred. Lean Manufacturing or Six Sigma certification or experience preferred. 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. COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies: Values: Integrity, Accountability, Teamwork, Innovation Excellent verbal and written communication skills Ability to work independently Ability to manage tight timelines and changing priorities Excellent problem -solving techniques Proficient with Microsoft office applications Skilled at providing technical leadership on cross-functional teams Hands on technical knowledge with manufacturing equipment Salary Range for this position: $113,000 - $136,000

Requirements

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.
Excellent verbal and written communication skills
Ability to work independently
Ability to manage tight timelines and changing priorities
Excellent problem -solving techniques
Proficient with Microsoft office applications
Skilled at providing technical leadership on cross-functional teams
Hands on technical knowledge with manufacturing equipment

Nice To Haves

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.

Responsibilities

Provide technical support for day-to-day manufacturing line operations, troucleshooting 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).
Designs tools and machines used to manufacture medical products.
Reviews production program equipment, hardware, and tooling; makes recommendations for servicing, specific repairs or replacement.
Develop and optimize manufacturing processes for scalability, efficiency, and quality.
Installs new equipment and ensures correct operation; trains others to operate new machinery.
Maintains a general knowledge of new and developing manufacturing technology, equipment, and applications; applies 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.
Performs other duties assigned as needed.