Senior Manufacturing Engineer

Senior Manufacturing Engineer

Location: Milwaukee, WI (On site)

Compensation: $100,000-$110,000 base salary; bonus eligible

About the Opportunity

A growing manufacturer is seeking a Senior Manufacturing Engineer to support assembly operations, lead new process introductions, and drive continuous improvement across production lines. This is an opportunity for a hands-on engineering professional who enjoys bridging process development and production. The ideal candidate brings experience launching new assembly processes from initial quoting and tooling development through first article inspection, process validation, and release to production. You will work closely with Production, Quality, and Process Engineering to ensure assembly processes are robust, repeatable, well-documented, and capable of meeting quality and delivery expectations.

Key Responsibilities

New Process Introduction & Production Handoff

• Lead new assembly process introductions from initial quoting and process development through first article inspection, validation, and production release.
• Collaborate with Process Engineering to ensure smooth transitions from new product development into production.
• Participate in process handoff reviews and establish clear documentation, training, and support requirements.
• Support process requalification when changes affect product form, fit, or function.

Assembly Process Engineering

• Own the performance of assigned assembly and sub-assembly stations, monitoring yield, scrap, rework, and cycle time.
• Troubleshoot production-floor challenges involving component fit, fastening, fixtures, and assembly methods.
• Design or specify assembly fixtures, tooling, and process parameters for torque, fastening, adhesives, sealants, and press-fit applications.
• Maintain and improve existing production equipment, fixtures, torque tools, and gauges.

Continuous Improvement & Root Cause Analysis

• Lead root cause investigations and corrective actions using methodologies such as 5 Why, fishbone, and 8D.
• Drive measurable improvements in quality, productivity, cycle time, scrap, and rework.
• Identify opportunities for line balancing, improved kitting, fixture enhancements, automation, and error-proofing.
• Lead engineering change requests and assess downstream impacts to assembly processes and production documentation.

Documentation, Validation & Training

• Develop and maintain process documentation, including PFMEAs, control plans, work instructions, and validation records.
• Lead process validation activities, including IQ/OQ/PQ or equivalent methodologies.
• Support first article inspections and maintain compliance with applicable quality system requirements.
• Train and certify production operators on assembly procedures and updated processes.
• Serve as a technical resource for production teams and support internal and customer audits.

Qualifications

• 5+ years of manufacturing or process engineering experience in mechanical or electromechanical assembly environments.
• At least 3 years of experience launching new assembly processes.
• Demonstrated ownership of new process introductions from initial quoting through first article, validation, and production release.
• Experience developing or specifying assembly fixtures, tooling, and production process parameters.
• Strong knowledge of root cause analysis, corrective action, and continuous improvement methodologies.
• Experience creating and maintaining PFMEAs, control plans, work instructions, and engineering change documentation.
• Experience with process validation and first article inspection in an ISO 13485, ISO 9001, or similarly regulated environment.
• Proficiency in SolidWorks or equivalent CAD software.
• Bachelor's degree in mechanical, Manufacturing, Industrial, Biomedical Engineering, or a related technical field. Equivalent engineering-related experience may be considered in place of a degree.

Preferred Qualifications

• Medical device or other regulated manufacturing experience.
• Lean or Six Sigma certification at the Green Belt level or higher.
• Experience mentoring engineers and training production operators.
• Background in complex electromechanical product assembly.