Manufacturing Process Engineer

Intellectt Inc; Irvine (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

An established industry player is seeking passionate Manufacturing Engineers to enhance their surgical product manufacturing processes. This role involves collaborating with various teams to ensure high-quality output and compliance with regulatory standards. You'll design tooling and equipment while driving continuous improvement initiatives. If you have a strong background in the medical device industry and a knack for problem-solving, this is a fantastic opportunity to make a significant impact in a dynamic environment. Join a team dedicated to innovation and excellence in the life sciences sector.

Qualifications

• 6+ years of engineering experience, with 3 years in medical device industry.
• Strong knowledge of manufacturing processes and quality assurance.
• Ability to analyze and troubleshoot manufacturing processes.

Responsibilities

• Collaborate with cross-functional teams to ensure smooth manufacturing.
• Design and develop tooling and equipment for manufacturing processes.
• Lead efforts to reduce rework and optimize manufacturing efficiency.

Skills

GMPs

ISO 13485

Manufacturing Process Validation

Six Sigma

Lean Manufacturing

Mechanical Assembly

Communication

Teamwork

Cross-Functional Collaboration

Financial Analysis

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Manufacturing Engineering

Bachelor’s degree in Biomedical Engineering

Tools

Oracle

Job description

Direct message the job poster from Intellectt Inc

Passionate Recruiter – connecting and hiring talents to support the Life Science/Pharmaceutical industry/ medical devices/manufacturing roles

We are seeking a highly skilled 5 Manufacturing Engineers to join our team, supporting the design, implementation, and validation of manufacturing processes for surgical products in the medical device industry. This is a critical role that involves working within cross-functional teams to improve product quality, reduce waste, and drive continuous improvement across manufacturing processes.

Key Responsibilities:

• Collaborate with Quality Assurance, Supplier Quality, Regulatory, Manufacturing, and Planning teams to ensure the smooth operation of manufacturing processes for surgical products.
• Design, develop, specify, and purchase tooling, fixtures, and equipment used in the manufacturing process.
• Manage the implementation and validation of new or modified manufacturing processes and equipment, focusing on IQ/OQ/PQ validation.
• Support material selection and validation for polymers, metals, adhesives, and other materials used in medical devices.
• Create and maintain BOMs, Routers, and DMRs, ensuring that all manufacturing processes meet regulatory requirements and are well-documented.
• Lead efforts to reduce rework, scrap, and labor variance while optimizing manufacturing efficiency.
• Investigate and resolve manufacturing-related problems through the Material Review Board process, ensuring high product quality and compliance.
• Identify and implement innovative manufacturing technologies and best practices to improve processes and product quality.
• Serve as a technical expert, providing manufacturing engineering knowledge to resolve issues and improve existing products and processes.
• Represent the Manufacturing Engineering group on key projects and drive continuous improvement across all manufacturing operations.

Desired Qualifications:

• Bachelor’s degree in Mechanical, Manufacturing, Materials, or Biomedical Engineering (or equivalent).
• Minimum of 6 years of engineering experience, with at least 3 years in the medical device industry.
• Strong knowledge of GMPs, ISO 13485, and manufacturing process validation (IQ, OQ, PQ).
• Experience with metal processing (machining, polishing, welding), plastics processing, and mechanical assembly.
• Knowledge of Six Sigma, Lean Manufacturing, and Continuous Improvement methods.
• Expertise in machine/tool design and equipment startup (preferred).
• Experience in a cleanroom environment is a plus.
• Ability to analyze and troubleshoot manufacturing processes, improving equipment uptime, yield, and quality.
• Experience with financial analysis related to project cost assessments and capital purchases.
• Strong communication, teamwork, and cross-functional collaboration skills.
• Familiarity with Agile and Oracle systems is a plus.
• Ability to travel up to 10% domestically.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Chemical Manufacturing

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