Manufacturing Process Engineer

Job Description:

We're seeking a hands-on Manufacturing Process Engineer to improve and support our production operations through process optimization, data-driven problem solving, and implementation of lean manufacturing practices. This hybrid role combines process engineering's analytical rigor with the practical focus of manufacturing support. The role will be full time on-site.

Responsibilities:

• Analyze and improve manufacturing processes for safety, quality, and efficiency.
• Develop and implement process improvements to reduce cycle time, scrap, and downtime.
• Support daily production operations with root cause analysis and corrective actions.
• Design or modify process layouts, tooling, and fixtures to enhance manufacturability.
• Develop and maintain process documentation (work instructions, control plans, PFMEAs).
• Lead continuous improvement projects using Lean/Six Sigma methodologies.
• Train production teams and implementation of new automated processes effectively.
• Collaborate with design engineering to ensure products are optimized for manufacturability (DFM).
• Maintain and revises Engineering Document (ECR), generate (SOP), Manufacturing Control Instructions (MCI)
• Perform investigation on Material Review Disposition Record (MRDR) and apply countermeasure to eliminate root cause for failed parts
• Participate in new equipment specification, installation, and validation.
• Able to lead projects from start to finish and works well cross-functional teams.
• Responsible for finding the root cause to problems and creating then implementing a solution.
• Develop product cost estimates, and project cost, equipment cost and timeline estimates.
• Provide technical input for capital appropriation requests.
• Follows quality and safety protocols and maintains a clean working environment. 
• Perform other duties and responsibilities assigned by Manager.

Job Requirements:

Minimum Qualifications:

• Bachelor's degree in Mechanical, Manufacturing, or Industrial Engineering.
• 2–7 years of experience in a process, manufacturing, or production engineering role.
• Proven ability to analyze data and drive measurable process improvements.
• Working knowledge of Lean principles, SPC, and root cause tools (5 Whys, Fishbone, etc.).

Preferred:

• CAD proficiency is a plus
• ERP or manufacturing engineering systems are a plus.
• Six Sigma Green Belt or equivalent.
• Experience with automation or process control.
• Background in continuous improvement in high-volume or precision manufacturing.
• Experience working with 3D printing
• Experience working in medical device or FDA regulated industries

Abilities:

• Strong communication and cross-functional teamwork skills.
• Must possess excellent communication (Technical, Oral, Written) and the ability to describe complex technical issues clearly.
• Sound understanding of regulatory and compliance documentation processes, review cycles and information repositories (meeting minutes, templates, charter documentation etc).
• Strong interpersonal skills that create followership and motivate team members.
• Driven and motivated individual with demonstrated critical thinking and analytical skills.
• Unquestionably high ethical standards and attention to reputational and compliance risks.
• Organized thinker that can prioritize tasks in real time and exercise judgment in high-paced environment.
• Plan, conduct, lead, and report on assigned projects.  Review progress, evaluate results, and inform company management on assigned project status.
• Ability to travel at least 5% of the time to various manufacturing sites to oversee process implementation and provide on-site support

Physical Demands:

• Working hours and shifts will vary and are dependent upon the work cycles required by business needs. 
• The noise level in the work environment is usually low to moderate.
• Due to the nature of product contents, careful handling and compliance to procedure and processes are required.
• Ability to stand and/or sit for long periods of time as required by business needs.
• Occasionally push, pull, lift and/or bend as required by business needs.
• Must be able to lift 25 pounds.

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