Manufacturing Engineer II (Irvine)

Job Summary :

The Manufacturing Engineer will play a key role in our medical technology company, which designs and manufactures innovative medical devices. This position will support the development, optimization, and validation of manufacturing processes for medical devices and consumables. The engineer will collaborate cross-functionally to scale production, improve efficiency, and ensure compliance with regulatory requirements. The ideal candidate will be hands-on, analytical, and process-driven, with a passion for lean manufacturing and continuous improvement.

The manufacturing engineer will independently support moderate complexity processes for New Product Introduction (NPI) and existing production lines, and contribute to process improvement initiatives using Lean and Six Sigma tools.

Duties & Responsibilities :

Develop and implement manufacturing processes for new and existing medical devices (NPI and legacy products).

Draft and maintain work instructions, acceptance procedures, validation and technical documentation in compliance with company quality standards.

Lead small-scale yield, efficiency, or cost-reduction projects.

Support daily production troubleshooting and process monitoring.

Collect and analyze production data under guidance, and communicate findings to stakeholders

Design, develop and qualify equipment, tooling, and fixtures used in production.

Perform equipment qualifications, process validations (IQ, OQ, PQ) and develop Master Validation Plans and Reports (VMP / VMR) ensuring robust and repeatable manufacturing operations.

Apply Lean Manufacturing principles (5S, Value Stream Mapping, Standard Work, and Continuous Flow) to identify and eliminate waste, reduce costs, and improve workflow efficiency.

Perform statistical analysis (e.g., SPC, Gage R&R, Cpk, ANOVA, DOE) to develop, monitor and improve processes and performance.

Conduct time studies, Root Cause Analyses (RCA), and capability studies to support data-driven decision making.

Create and maintain Process Failure Mode and Effects Analyses (pFMEA) and assist in the development of control plans and risk mitigation strategies.

Ensure compliance with FDA regulations (21 CFR Part 820), ISO 13485, and company-specific quality system requirements.

Collaborate with R&D, Quality, and Production teams to support design transfer, process scale-up and troubleshooting activities.

Train production personnel on new or revised processes.

Support continuous improvement projects and Kaizen events to enhance product quality and operational efficiency.

Minimum Qualifications and Experience :

Bachelors degree in Mechanical, Biomedical, Electrical, Manufacturing or Industrial Engineering (or other related field).

36 years of experience in manufacturing or process development, preferably within the medical device or a regulated industry.

Good understanding of GMP, FDA, or ISO 13485.

Working Knowledge of lean manufacturing tools (5S, Value Stream Mapping, Poka-Yoke, etc.).

Proficient with process validation and quality system regulations (IQ / OQ / PQ, CAPA, NCRs).

Experience with CAD solid modeling software (e.g., SolidWorks).

Proficient in Microsoft Office and statistical tools (e.g., Minitab, JMP, Excel).

Strong interpersonal, problem-solving, communication, organizational and documentation skills.

Ability to thrive in a fast-paced, team-oriented environment.

Desired Qualifications :

Proficient with 3D CAD design, preferably SolidWorks; CSWA certification or higher is highly desirable.

Good knowledge of Design for Manufacturability (DFM), Design for Assembly (DFA), Six Sigma methodologies, and risk management tools such as pFMEA.

Yellow Belt or Lean Manufacturing training.

Experience with MES and ERP systems.

Hands-On experience with specialized manufacturing processes, including soldering, adhesive bonding, laser welding, and ultrasonic welding.

Physical requirements / Work Environment

This position is in Irvine, CA.

This position is primarily based in an office environment and involves frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may also require standing for extended periods while facilitating meetings or walking through production and facility areas. Occasional local travel is expected; therefore, the ability to operate a motor vehicle and maintain a valid drivers license is required

The physical demands described are considered essential functions of the role. Employees must be able to perform these tasks for extended periods. Reasonable accommodations may be provided to individuals with disabilities to enable them to perform the essential functions of the position.

What We Offer

• A collaborative and mission-driven workplace
• Competitive compensation and benefits
• Opportunities for training, growth, and career advancement
• The opportunity to contribute directly to products that improve patient health and well-being