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Scientific. Clinical. Software Engineering

Sr Manufacturing Engineer

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -082019-25477 Region: Orange County Metro Area

Job Description

Sr Manufacturing Engineer

Medical Device Industry

Laguna Hills, CA

Essential Duties and Responsibilities:

Responsible for leading engineering projects as they relate to our product and process development activities. Works closely with product development teams for both capital and disposable medical devices and manage products through all stages of its product life cycle. This position will work cross functionally with other functions of our organization to achieve key strategic objectives. Lead cross-functional project teams as assigned.

Support design and development of new products at both the system and component level as it relates to manufacturing

Participate in design reviews during the product development cycle to ensure designs are capable to meet full scale production

Ability to persuade and inform engineering teams to implement changes for design for manufacturability

Provides manufacturing engineering support for complete integration of new products into full production

Ability to use Design for Six Sigma Methodology to drive improvements for manufacturability in new product development

Initiate, prepare, conduct and document formal qualification and validation

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

Ability to use lean manufacturing practices and six sigma methodology to evaluate and improve assembly line and product performance

Ability to work with suppliers on key component issues as it relates to manufacturing to implement process controls

Initiates and prepares project feasibility studies, prepare timelines, manage and execute to timelines

Ability to produce progress reports to inform management of project status

Ability to work cross functionally and communicate effectively, verbally and written to a broad audience

Identify potential medical device hazards and assist with maintaining Risk Management files

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

Education and/or Work Experience Requirements:

Requires a BSME or equivalent with 5-8+ years of experience.

Medical device manufacturing experience essential; plastic part assembly, metal machining, fluidics knowledge, low volume - high pressure fluid systems desirable.

Experience in Product development and product transfer 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.

Proficient knowledge in applying Statistical Analysis such as, but not limited to:

Process capability

Hypothesis Testing


Process Capability



Proficient experience in applying DFSS/Lean Six Sigma elements into Manufacturing problems

Knowledge of machine shop practices desirable

Must be a hands-on problem solver.

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

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position is primarily sedentary and employee may be required to sit for extended periods of time. Standing, walking and meeting activities are required frequently throughout the workday. Employee must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.). A large portion of the day is spent communicating orally in person and by phone. Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.

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