Manufacturing Process Engineer II

Abbott; Saint Paul (MN); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a detail-oriented Development Process Engineer to enhance manufacturing and product development initiatives. This role is pivotal in optimizing processes, ensuring product quality, and driving strategic objectives. The ideal candidate will leverage their expertise in process validation and quality engineering within a medical device environment. You will collaborate with cross-functional teams, lead continuous improvement initiatives, and provide mentorship to junior engineers. Join a forward-thinking organization that values innovation and quality, and contribute to life-changing breakthroughs in healthcare.

Benefits

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

401(k)

MetLife Legal and ID Fraud Insurance

Qualifications

• 2-5+ years of relevant experience in manufacturing or process engineering.
• Strong understanding of engineering principles and quality systems.

Responsibilities

• Support manufacturing operations by improving processes and integrating new ones.
• Analyze equipment and production parameters to resolve quality issues.

Skills

Process Validation (IQ/OQ/PQ)

Manufacturing Engineering

Quality Engineering

Statistical Analysis (Minitab)

Problem-Solving Skills

Education

Bachelor’s degree in Engineering

Tools

Minitab

SolidWorks

Job description

Title: Manufacturing Process Engineer II/ Development Process Engineer

Location: St. Paul, MN

Duration: 12 Month Assignment

Position Overview:

We are seeking a detail-oriented and results-driven Development Process Engineer/ Manufacturing Process Engineer II to support both manufacturing and product development initiatives. This role will focus on optimizing new and existing processes, improving production efficiency, ensuring product quality, and contributing to strategic manufacturing objectives. The ideal candidate will have a strong background in process validation, manufacturing engineering, and quality systems, along with experience in medical device environments.

Key Responsibilities:

• Support manufacturing operations by improving existing processes and integrating new ones to meet production, quality, and efficiency goals.
• Analyze equipment, tooling, and production parameters to resolve issues that cause non-conforming products, reduced yield, or quality deviations.
• Participate in the development and execution of process validation activities (IQ/OQ/PQ).
• Collaborate with R&D, Quality, and other cross-functional teams to transition new product designs into full-scale manufacturing.
• Lead or support continuous improvement initiatives using tools such as Minitab and Six Sigma methodologies.
• Author and maintain technical documentation including engineering protocols, reports, validation documents, and standard operating procedures (SOPs).
• Provide technical mentorship to junior engineers and production staff as needed.
• Contribute to root cause analysis, corrective and preventive actions (CAPA), and risk assessments.
• Communicate effectively with internal and external stakeholders, including presenting findings and recommendations.
• Ensure compliance with internal quality standards and applicable industry regulations.

Preferred Technical Tools & Skills:

Required:

• Process Validation (IQ/OQ/PQ)
• Experience in Manufacturing and Quality Engineering
• Statistical analysis using Minitab

Nice to Have:

• Experience with SolidWorks or similar CAD tools
• Knowledge of design principles and manufacturing for medical devices
• Report writing and documentation in regulated environments
• Exposure to medical device design and manufacturing standards (e.g., ISO 13485, FDA 21 CFR Part 820)

Qualifications:

• Education: Bachelor’s degree in Engineering or related technical field.
• Experience: 2–5+ years of relevant experience in manufacturing, process engineering, or quality engineering, preferably in the medical device industry.
• Strong understanding of engineering principles, validation practices, and quality systems.
• Excellent problem-solving skills with a hands-on, analytical approach.
• Familiarity with regulated environments and compliance standards (e.g., FDA, ISO).
• Ability to work independently as well as collaboratively in a cross-functional team environment.

Consultants Eligible Benefits Upon Waiting Period:

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (for High Deductible Health Plans)

Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)

Supplemental Life Insurance

Short Term Disability (coverage varies by state)

Long Term Disability

Critical Illness, Hospital coverage, Accident Insurance

MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance

401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.