Manufacturing Engineer

Sonendo IncLaguna Hills, CA, US

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Job Description

Sonendo, Inc. is a medical technology company with a unique mission to lead the transformation of dentistry through Sound Science®. We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity. We believe our success is based on developing disruptive technologies, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision.

Essential Duties and Responsibilities :

Provide engineering, management and technical skills to leadership and support of manufacturing personnel to achieve Continuous Improvement, Quality, Compliance and Operational metrics. Assist the Senior Manager in leading the activities of assemblers and manufacturing leads in the production area. Activities include ensuring production schedules are met, manufacturing procedures are followed, and all production personnel trained to those procedures.

Supervise up to 20 production personnel and activities to effectively support manufacturing needs to meet customer requirements for existing commercial products, clinical builds and R&D builds.
Tracks and summarizes and reports key indicator data and metrics for area(s) of responsibility.
Assigns and adjusts workloads to meet provided week to week goals
Responsible for ensuring compliance to quality systems (FDA, GMP, QSR, ISO), product specifications, process instructions, safety requirements and company policies. Includes the diligent management of non-conformances to ensure appropriate corrective and preventive actions.
Manage timely completion of equipment PM and calibrations
Proactively identifies potential failure modes relative to quality.
Investigate and resolve non-conformances identified on the manufacturing line.
Initiate, design and build test fixtures to test or evaluate components and systems for line set up
Ability to determine root cause of failure investigations and implement solutions using risk-based decision making
Deliver medical device design documentation compliant with FDA design controls and good documentation practices including creating and maintaining medical device Design History Files and Device Master Records
Participate in Risk Management activities. Provide technical expertise pertaining to the identification and mitigation of design and use risks.
Perform other duties as assigned by supervisor
Maintain compliance with Quality System procedures and company policies

Education and / or Work Experience Requirements :

Requires a BSME or equivalent with 0-2 years of experience, or Masters degree.

Manufacturing experience preferred; plastic part assembly, metal machining, fluidics knowledge, low volume - high pressure fluid systems desirable.

Lean Manufacturing expertise is preferred.

Knowledge of ISO, FDA, UL and CE requirements as they relate to manufacturing.

Proficient with Solidworks, Minitab or equivalent, Microsoft Project, PowerPoint, Word and Excel.

Knowledge in applying Statistical Analysis such as, but not limited to : Process capability, Hypothesis Testing, Anova, Process Capability, GR&R, DOE.

Experience in applying Lean and / or Six Sigma principles in Manufacturing processes

Must be a hands-on problem solver.

Must have demonstrated cross-functional team effectiveness, excellent interpersonal and written communication skills.

Working knowledge of quality system requirements (QSR) and good manufacturing practices (GMP).

Experience with Statistical Process Control (SPC) is preferred.

Physical Requirements :

Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and / or quantitative productivity standards.

Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards

Must be able to safely move up to 25 lbs

The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.

Must be able to remain in a stationary position for 50% of the time.

Must be able to occasionally move about inside the office to access file cabinets, office machinery, etc.

The ability to observe details at close range (within a few feet of the observer).

Compensation :

We pay competitively. Base salary range is $74,000 - $89,000. Other paid compensation and benefits may be available.

Additional Information :

Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization. If you are interested in applying for this position, please apply online.

No recruiters, please.

Sonendo, Inc. is an Equal Opportunity Employer

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Manufacturing Engineer • Laguna Hills, CA, US