Senior Manufacturing Engineer

Life Science Outsourcing, Inc.; Brea (CA); On-site; USD 125,000 - 145,000; Full time

Job summary

A leading company in medical device manufacturing is looking for a Senior Manufacturing Engineer to enhance production processes and ensure regulatory compliance. The ideal candidate will have significant experience in engineering within regulated environments, focusing on cost reduction and manufacturability improvements. This role involves overseeing automation initiatives and optimizing equipment for medical device manufacturing, ensuring high standards are met throughout the process.

Qualifications

• 7 years of relevant manufacturing engineering experience.
• Experience in a regulated industry such as medical devices or pharmaceuticals.
• Proficient in project management tools and methodologies.

Responsibilities

• Design and optimize manufacturing systems and processes.
• Manage projects and lead initiatives to drive efficiency.
• Ensure compliance with industry standards and regulations.

Skills

Lean manufacturing

Six Sigma

Process improvement

Project management

Manufacturing systems

Regulatory compliance

CAD/CAM systems

Statistical analysis

Education

Bachelor’s degree in Engineering

Tools

ERP systems

ISO 13485 standards

PFMA

DFMA

CAD (e.g., SolidWorks)

Minitab

Job description

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Design, integrate, and improve manufacturing systems and related processes. Collaborate with customers and designers to refine product designs, enhancing manufacturability and reducing costs. Manage projects using project management tools, leading efforts to streamline manufacturing processes for new products and engineering initiatives. Apply lean principles and advanced manufacturing technologies to drive efficiency and minimize waste. Spearhead automation initiatives to optimize manufacturing processes, and other critical packaging operations. Oversee and execute the validation and optimization of equipment for medical device manufacturing, ensuring compliance with industry standards for manufacturing, packaging integrity, seal strength, and sterile barrier maintenance

Requires a Bachelor’s degree in Engineering or related plus 7 years of Manufacturing Engineering experience in a regulated industry (e.g., medical devices, pharmaceuticals, aerospace).

Requires skills and experience in the following: 2 years of experience managing multiple products or projects. Expertise in the following regulated industries, medical devices, pharmaceuticals, or aerospace, ensuring familiarity with industry-specific standards and regulatory requirements. In-depth knowledge of lean manufacturing, Six Sigma, and process improvement methodologies. Proficient in ISO 13485 standards and related quality management systems. Experience with cleanroom environments and standards. Experience in manufacturing a diverse range of medical devices, including implants, orthopedic devices, and packaging. Experience with precision assemblies. Experience with sterilization processes, including autoclave and other common methods for medical devices. Knowledge of ultrasonic cleaning and other medical device cleaning techniques. Proficiency with PFMA ((Process Failure Modes and Effects Analysis), DFMA ((Design for Manufacturing and Assembly) and GD&T (Geometric Dimensioning and Tolerancing). Proficiency creating Routings, BOMS ((Bill of Materials) and Labor Standards calculation and definition. Proficiency in ERP (Enterprise Resource Planning) systems for managing production workflows and materials planning. Proficiency in CAD/CAM systems (e.g., SolidWorks) and machining principles for tooling design, and assembly, including building and design of tools, jigs, fixtures, and specialized equipment to support efficient and accurate manufacturing and assembly processes. Proficiency in project management and using tools (e.g., Asana or equivalent) to oversee new product introduction (NPI) and complex engineering projects. Experience with operating and maintaining manufacturing and testing equipment, including vision systems, ultrasonic cleaners, UV and 3D printers, and pouch sealing machines. Expertise in Process and equipment validation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Experience with packaging validation for medical devices. Experience with Lucid chart for process mapping. Experience in prototype development, R&D designs, and full product transfers, including Design for Manufacturing (DFM) transfers. Proficiency in Minitab for statistical analysis and process controls.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Other

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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