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Senior Mechanical Engineer

iTech US Inc
San Francisco, California, United States
February 15, 2018

iTech US Inc. provides end-to-end solutions for customized Software Development Solutions and IT consulting services for Fortune 1000 clients.

We Have Senior Mechanical Engineer Job in San Francisco, CA

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Job Title: Senior Mechanical Engineer

Location: San Francisco, CA

Duration: 12 Months Contract

Job ID: 6297

Job Details:

Work with a cross functional team to create appropriate product requirements for the product to be designed and developed

The development and testing of single-use disposables for next generation laser eye surgery equipment

Research and learn appropriate ISO and other regulatory standards for applicable product types

Utilize system architecture diagrams, state transition diagrams and other tools to illustrate the appropriate sub-systems within the product and their relationship to one another.

Define the inputs and outputs needed to make the sub-systems work independently and then the system level inputs and outputs needed to make the system work when fully integrated.

Understand how to translate and articulate a user or stakeholder need into an engineering requirement.

Identify and assess Design Risk via a dFMEA

Work with the development team identify risks and generate appropriate test plans

Lead and/or co-facilitate a team through root cause analysis efforts.

Understanding of Operations / Supply Chain management

Facilitate requirement identification brainstorming sessions utilizing tools such as FAST or other techniques.

Identify potential technical risks and potential solutions within the product design, utilizing proper decision making tools and data to drive decisions.

Support program or project management by assisting with the creation of scope, cost and duration estimates for various tasks

Support product compliance by working with the Quality organization:

Adhere to facility and corporate quality systems, SOP’s & WI’s

Know and understand personal role in compliance to ISO 13485 w/ design controls, ISO14971 risk management, IEC 62366, IEC 60601 and ITAR as required

Ensure that design inputs and outputs are properly documented and controlled according to relevant procedures.

Work with Design Assurance to ensure Needs, Design Inputs and Design Outputs are all traceable.

Generate and control requirement documentation according to relevant work instructions.

Facilitate communication between team members, customer and flow through production facilities

Provide medical device expertise in design, product development and design verification for Single Use Disposables

Provides advice on feasibility and risks for a product

Facilitates cross-functional knowledge

Responsible for coordination of product development

Knowledge of standards (13485, 14971, 62304, IEC 60601)

Primary Skills:

Experience desired in a medical device or other regulated industry

Development and testing of single-use disposables for next generation laser eye surgery equipment

Working with Standards like 13485, 14971

Excellent written and verbal communication skills required

Proven ability to perform problem solving and troubleshooting required

Working experience Operations / Supply Chain management to ensure quality

Drive and contribute to dFMEA and pFMEA analysis

Experience with requirements management, configuration management, issue tracking tools, etc. required

Drive V&V test protocol generation, execution and report release

Must be self-motivated to drive innovation of product improvements or next generation products.

Drive V&V test protocol generation, execution and report release

Secondary Skills:

Working within multi-functional teams, actively participate in design reviews, Excellent Communication Skills

Must be self-motivated and able to work in a fast paced, team-oriented environment

Ability to work with minimal guidance to make decisions and report progress required.

Experience with injection molded component design

Experience with sterile package design

Experience with tolerance analysis

Experience in design for high-volume manufacturing

Experience working with animal and/or cadaver tissue

Experience in product design

Familiar with shop tools and equipment (i.e. lathe, mill, etc.)

Educational Qualifications:

BS in Mechanical Engineering or other Engineering discipline (MS Mechanical Engineering preferred)

5+ years of progressive development work experience

Familiar with sterile single-use disposable validation requirements

Proficiency in 3D Solid Modeling (SolidWorks preferred)

Familiar with drafting standards, dimensioning and tolerance

Thanks & Regards


iTech US, Inc.