Manufacturing Process Engineer - Medical Device

The Process Engineer ensures manufacturing processes are efficient, cost-effective, compliant with MICROs quality standards, and capable of consistently producing products that meet customer specifications.

JOB OUTCOMES

The Process Engineer will:

Lead projects that deliver measurable improvements in process efficiency, product quality, and cost reduction across assigned manufacturing areas.

Act as a Subject Matter Expert (SME) to resolve complex technical challenges, optimize process performance, and support cross-functional teams.

Drive sustainable process improvements through data-driven decision-making, root cause analysis, and the implementation of corrective and preventive actions.

Ensure that manufacturing processes consistently meet internal quality standards and customer specifications while remaining scalable and cost-effective.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Process Improvement 60%

• Lead or actively contribute to cross-functional project teams focused on improving process efficiency, product quality, and cost performance.
• Recommend and implement improvements to equipment, tooling, and work methods to increase throughput and optimize resource utilization.
• Collaborate in the design and specification of new equipment and tooling to meet production and quality requirements.
• Support the installation, testing, and optimization of new or modified equipment to ensure successful integration into manufacturing operations.
• Assist in developing and refining manufacturing processes to improve repeatability, yield, and operational reliability.
• Conduct root cause analyses of process issues and partner with Quality Engineers to implement sustainable corrective and preventive actions.

Process Analysis Documentation 40%

• Collect and analyze production and process data to identify trends, deviations, and improvement opportunities.
• Create clear, accurate process documentation including diagrams, workflows, and written instructions.
• Draft and revise detailed work instructions and standard operating procedures (SOPs) with input from senior engineers.
• Contribute to the development of validation documentation for new parts, design changes, and process updates.
• Assist in managing nonconforming material by documenting issues, coordinating evaluations, and supporting disposition activities.
• Interpret and apply tools such as Process Flow Diagrams (PFDs), Failure Mode and Effects Analyses (FMEAs), and Process Control Plans (PCPs) to ensure process control and risk mitigation.

TALENT MANAGEMENT

This position has no talent management responsibilities.

QUALIFICATIONS

EDUCATION AND EXPERIENCE

Bachelors degree in Engineering or a related field is required.

At least 4-6 years of engineering experience is required.

LICENSE AND CERTIFICATION

None

TECHNICAL SKILLS

Blueprint reading

Geometric Dimensioning and Tolerancing (GDT)

Statistical Process Control (SPC)

Measurement Systems Analysis (MSA, GRR)

Design of Experiments (DOE)

Statistical software systems

ERP

Minitab Statistical Software

Metal fabrication

Medical device manufacturing

MS Office Suite

OTHER SKILLS

Verbal communication

Written communication

Organizational skills

Problem solving

While performing the duties of this Job, the employee is regularly required to sit; and talk and hear. The employee is frequently required to stand; walk; use hands to touch, handle, or feel and reach with hands and arms.

The employee must lift, push, pull, carry and/or move up to 10 pounds frequently, and between 10 and 25 pounds occasionally.

While performing this Job, the employee is regularly required to demonstrate manual and spatial dexterity sufficient to operate machinery for precision work.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to vibration. The employee is occasionally exposed to wet and/or humid conditions; risk of electrical shock; and odors, dusts, mists, fumes and/or airborne particles.

The noise level in the work environment varies from moderate to loud, based on the department/ work area.

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