Job Description

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.

Duties & Responsibilities:

• Support the development and implementation of manufacturing processes for new and existing medical devices (NPI and legacy products).
• Assist in the design, development, and qualification of equipment, tooling, and fixtures used in production.
• Draft and maintain work instructions, SOPs, validation and technical documentation in compliance with company quality standards.
• Lead or support process validations (IQ, OQ, PQ) and 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 (PFMEAs) 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.
• Support continuous improvement projects and Kaizen events to enhance product quality and operational efficiency.

Minimum Qualifications and Experience:

• Bachelor’s degree in mechanical, Biomedical, Electrical, Manufacturing Engineering or related fields.
• 1–3 years of experience in a manufacturing or process engineering role, preferably within the medical device or regulated industry.
• Working knowledge of lean manufacturing tools (5S, Value Stream Mapping, Poka-Yoke, etc.).
• Familiarity with process validation and quality system regulations (IQ/OQ/PQ, CAPA, NCRs).
• Experience with solid modeling software (e.g., SolidWorks).
• Proficient in Microsoft Office and basic 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:

• Experience in cleanroom manufacturing and the assembly of electromechanical and sterile medical devices.
• Strong knowledge of Design for Manufacturability (DFM), Design for Assembly (DFA), Six Sigma methodologies, and risk management tools such as PFMEA.
• Proficient in 3D CAD design, preferably SolidWorks; CSWA certification or higher is highly desirable
• 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 driver’s 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

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