Sign in

Systems Engineer

Company:
iTech US Inc
Location:
San Francisco, California, United States
Posted:
February 15, 2018
Description:

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

We Have Systems Engineer Job in San Francisco, CA

If you are seeking to apply please do share your updated resume, contact detail and best time to reach you.

Job Title: Systems Engineer

Location: San Francisco, CA

Duration: 36 Months Contract

Required In Person Interview

Job ID: 6182

Overview:

- Experience desired in a medical device or other regulated industry

- Working on medical/ophthalmologic device development projects from initial concept through to release to market including product definition, systems architecture, design & development, and transfer to manufacture

- Statistical Analysis experience if preferred

- Working with Standards like 13485, 14971, 62304 is preferred

- Excellent written and verbal communication skills required

- Proven ability to perform problem solving and troubleshooting required

- Strong attention to detail required

- Demonstrated leadership role in test and issue ownership including ability to provide guidance and direction to less experienced technical personnel required

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

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

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

- Learn and understand the Design Development Process and tools and the interdependencies of the different functional areas

- 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.

- Review customer supplied technical information and organize it into a meaningful structure.

- 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.

- Provide guidance to team members on project applicable product standards.

- 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

Primary Skills:

- Experience desired in a medical device or other regulated industry

- Working on medical/ophthalmologic device development projects from initial concept through to release to market including product definition, systems architecture, design & development, and transfer to manufacture

- Statistical Analysis experience if preferred

- Working with Standards like 13485, 14971, 62304 is preferred

- Excellent written and verbal communication skills required

- Proven ability to perform problem solving and troubleshooting required

- Strong attention to detail required

- Demonstrated leadership role in test and issue ownership including ability to provide guidance and direction to less experienced technical personnel required

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

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

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

Educational Qualifications:

Minimum 5 years’ industry experience in product development environment required with a Masters in Mechanical /Electrical /Software Engineering

Minimum 7 years’ industry experience in product development environment required with a Bachelors in Mechanical /Electrical /Software Engineering

Secondary Skills:

• Electrical Design, Switchgear Design, Schematic Design

• Exposure to hands-on handling of electrical design activity (a hands-on exposure is must), expertise in handling AutoCAD (hands-on with AutoCAD is required)

Thanks & Regards