Job Summary: Under limited/minimal supervision, the Manufacturing Engineer is responsible for designing, implementing, and reviewing manufacturing processes, procedures, and equipment typically in a single manufacturing facility. This role supports the manufacture and assembly of new and existing products, identifies improved manufacturing techniques, and plans assembly layouts to optimize production, quality, cost, and safety. The position may also involve developing and deploying capital projects and developing Lean solutions for production and manufacturing engineering.

Responsibilities:

• Manufacturing Process Flow: Plans and designs basic manufacturing processes to improve the manufacture and assembly of new and existing products. Determines equipment and tooling needed to achieve manufacturing goals according to product and quality specifications. Develops manufacturing processes, work instructions, routings, and necessary production tooling.

• Process Improvement: Develops and implements process improvement projects focusing on manufacturing efficiency, material yield, safety, and cost. May lead small teams in developing and implementing process improvement efforts. Leads and implements Lean initiatives, including designing and implementing continuous improvements, developing best practices, measuring process improvements, and establishing visual management.

• Engineering Design Support: Provides guidance to engineering leadership regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Be a key contributor in the creation of PFMEAs.

• Regulatory Compliance: Ensures more complex processes and procedures comply with regulations. Applies frequent use and application of technical standards, principles, theories, concepts, and techniques. Documents all manufacturing processes in accordance with ISO standards.

• Remediation: Investigates and suggests corrective action to ensure product quality and resolve quality issues. Performs root cause analysis to resolve manufacturing and production system downtimes and provides technical information to support corrective actions and improvements.

• Tooling and Equipment Development: Develops and qualifies specialized assembly tooling and equipment (IQ, OQ, PQ). Interfaces with outside vendors for manufacturing, measurement, and test equipment selection.

• Inspection and Testing: Writes and executes test protocols. Analyzes process data to reduce material scrap and optimize processes. Designs and implements inspection strategies, including control plans, measurement techniques, and gauging. Coordinates and performs First Article Inspections per AS9102.

• Statistical Analysis: Applies statistical methods and performs mathematical calculations to determine manufacturing processes, staff requirements, production standards, value stream mapping, Kaizen, Kanban, setup time reduction, single piece/small batch process flow, 5S process, machine capability studies, Cpk/Ppk, X-Bar&R charts, and establishes control limits.

• Additional Responsibilities: Performs additional responsibilities as assigned.

Basic Hiring Criteria:

• Bachelor’s Degree in a related Engineering field with 2-5 years of experience.

Desired Qualifications:

• Proficient/Working knowledge and ability to apply concepts of engineering for one solution line.

• Ability to apply a systematic, disciplined, and analytical approach to problem-solving of moderate to difficult scope and complexity.

• Effectively apply continuous improvement methods to quality and manufacturing functions (e.g., pull systems, process mapping, JIT).

• Proficient/Working knowledge of data structures and database programming.

• Ability to work effectively with CAD/CAM systems or other computer-aided manufacturing systems, in addition to standard business application software and/or specialized data analysis tools.

• Ability to use existing procedures to solve problems.

• Ability to read and understand moderate to complex engineering drawings and specifications.

• Working knowledge of geometric dimensioning and tolerancing (GD&T).

• Ability to research and analyze data effectively and draw valid conclusions.

• Strong verbal and written communication skills.

• Well-organized, detail-oriented, and able to multi-task.

• Strong computer skills, including proficiency with Microsoft Word, Excel, PowerPoint, Access, Outlook, and web browsers.

Prerequisites:

• Bachelor’s Degree in Engineering or equivalent.

• Minimum five (5) years of manufacturing engineering experience in a controlled environment.

• Experience with ERP systems.

• Proficient in Solid Works CAD Software.

• Working knowledge of inspection methodologies.

• Experience with the generation, release, and change control of various document types.

Required Skills:

• Strong verbal and written communication skills.

• Strong troubleshooting and evaluation intuitiveness.

• Excellent problem-solving and time management skills.

• Works precisely and pays close attention to details.

• Strong mechanical aptitude and knowledge.

• Self-motivated and highly organized.

• Good interpersonal skills, tactful, mature, and flexible.

• Strong supporter and advocate of company values.

• Knowledge of electronic equipment and computer hardware and software, Excel, MS Office.

Preferred Skills:

• Strong knowledge of LEAN, Six-Sigma, SPC, Shainin, and other process capability and problem-solving tools.

• Background in the Medical Device industry.

• Experience with precision machining and machine tools.

• Knowledge of automated assembly equipment and techniques.

• Experience with plastic injection molding and injection molding systems.

• Proficient with Design for Manufacturability (DFM) practices and LEAN Manufacturing principles.

• Familiar with ultrasonic welding of plastic materials.

• Knowledge of material cleaning and passivation processes.

• Clean room assembly practice (cGMP) experience.

• Laser marking of plastic and stainless steel.

International Trade Compliance Requirements:

This position requires the use of information subject to the International Traffic in Arms Regulations (ITAR). It requires either a US Person (as defined in applicable export regulations) or a non-US person eligible to obtain the required export authorization.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance