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Software Engineer

In California / United States

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Software Engineer   

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JOB TITLE:

Software Engineer

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Carlesbad California / United States

JOB DESCRIPTION:

Competencies:

• Technical expertise:
o Design: object-oriented design principles, C/C++ programming, low level software interfaces.
o Design: communication protocols – USB, SPI, I2C, RS232, Ethernet, WiFi, BT, etc.
o Design: Real Time Operating System kernel services, ARM-based microcontrollers.
o Regulations: IEC 62304, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR, etc.
o Solid Software Engineering fundamentals and problem solving skills in hardware up through system-level.

• Documentation:
o Verification & validation plans, protocols, and reports.
o Project plans, project schedules, risk / benefit / cost analysis.

• Process:
o Design control, quality system, risk management, dFMEA, PDP, CAPA.
o Software design process from concept to architecture to production.
o System development process – concept, system bring up and debug.

• Work habits:
o Strong communication and presentation skills.
o Communicate ideas and issues effectively to other team members and management.
o Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
o Strong multidisciplinary collaboration experience – EE, ME, FW, SW, QA, RA, Marketing, Clinical, etc.
o Work closely with cross-functional teams in NPI and sustaining projects.
o Experience with team collaboration and project management tools.
o Work in a matrixed environment to meet company objectives.
o Actively learn to become the domain expert on our gas sensing devices.

Essential Functions:
• Write, update and execute manual and automated test procedures for medical devices
• Analyze test protocols to ensure that test coverage of software requirements is complete and correct
• Work with software engineers and software test engineers to analyze test failures and determine root cause
• Maintain tools and equipment used by the software development and test teams
• Coordinate the return of equipment to the Calibration department for periodic maintenance

• Review and assess the impact of equipment that fails calibration, and documenting calibration requirements for newly acquired equipment
• Follow applicable Quality System procedures for all assigned tasks
• Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
• Communicate ideas and issues effectively to other team members and management.
• Prepare V&V documents, technical reports, presentations, as required.

• Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g. IEC 62304, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR).
• Assists engineering team in problem solving issues.
• Additional responsibilities may be assigned, as required, by management.

Education and Experience:
• Bachelor’s or Master’s Degree in Computer Science, Software Engineering or equivalent.
• 5+ years of software testing or related experience
• 5 - 10 yrs of experience in medical device (capital equipment) or related fields (regulated industry preferred).
• Strong written and verbal communications skills
• Strong attention to detail

• Familiar with Agile SW Development practices
• Design verification test development, execution, report generation.
• Experience with LabVIEW a plus
• Knowledge of product development process and design control from concept to volume production.
• Knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.

• Knowledge of medical device regulations and standards (e.g. IEC 60601-1, EU-MDR, FDA cGMP).
• Understanding of capnography or gas sensing products, applications, and technologies a plus.
• Six Sigma (DFSS) Green Belt certification with actual project experience a plus.
• Solid OEM / ODM / CM experience.

Soft Skills:
• Leadership: The ability to make things happen by encouraging and channeling the contributions of others, recognizing and addressing important issues in a timely manner, and acting as an agent for change and continual improvement when required to achieve results.
• Accountability/Ownership: Work closely with team members and take ownership and deliver fast – educate and communicate to the team.
• Influence: The demonstrated ability to gain acceptance and commitment from other to one’s own beliefs and ideas.
• Negotiating: The ability to construct and maintain a strong bargaining position so as to ensure positive response and agreement: striving for win-win situations.
• Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
• Data-Driven Decision Making: the ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.


DUE TO BUDGET CONSTRAINTS: New Bill Rate will be $55-$60/hr

Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204860965146318

LOCATION:

California / United States

CITY:

Carlesbad

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Software Engineer    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Competencies:

• Technical expertise:
o Design: object-oriented design principles, C/C++ programming, low level software interfaces.
o Design: communication protocols – USB, SPI, I2C, RS232, Ethernet, WiFi, BT, etc.
o Design: Real Time Operating System kernel services, ARM-based microcontrollers.
o Regulations: IEC 62304, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR, etc.
o Solid Software Engineering fundamentals and problem solving skills in hardware up through system-level.

• Documentation:
o Verification & validation plans, protocols, and reports.
o Project plans, project schedules, risk / benefit / cost analysis.

• Process:
o Design control, quality system, risk management, dFMEA, PDP, CAPA.
o Software design process from concept to architecture to production.
o System development process – concept, system bring up and debug.

• Work habits:
o Strong communication and presentation skills.
o Communicate ideas and issues effectively to other team members and management.
o Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
o Strong multidisciplinary collaboration experience – EE, ME, FW, SW, QA, RA, Marketing, Clinical, etc.
o Work closely with cross-functional teams in NPI and sustaining projects.
o Experience with team collaboration and project management tools.
o Work in a matrixed environment to meet company objectives.
o Actively learn to become the domain expert on our gas sensing devices.

Essential Functions:
• Write, update and execute manual and automated test procedures for medical devices
• Analyze test protocols to ensure that test coverage of software requirements is complete and correct
• Work with software engineers and software test engineers to analyze test failures and determine root cause
• Maintain tools and equipment used by the software development and test teams
• Coordinate the return of equipment to the Calibration department for periodic maintenance

• Review and assess the impact of equipment that fails calibration, and documenting calibration requirements for newly acquired equipment
• Follow applicable Quality System procedures for all assigned tasks
• Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
• Communicate ideas and issues effectively to other team members and management.
• Prepare V&V documents, technical reports, presentations, as required.

• Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g. IEC 62304, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR).
• Assists engineering team in problem solving issues.
• Additional responsibilities may be assigned, as required, by management.

Education and Experience:
• Bachelor’s or Master’s Degree in Computer Science, Software Engineering or equivalent.
• 5+ years of software testing or related experience
• 5 - 10 yrs of experience in medical device (capital equipment) or related fields (regulated industry preferred).
• Strong written and verbal communications skills
• Strong attention to detail

• Familiar with Agile SW Development practices
• Design verification test development, execution, report generation.
• Experience with LabVIEW a plus
• Knowledge of product development process and design control from concept to volume production.
• Knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.

• Knowledge of medical device regulations and standards (e.g. IEC 60601-1, EU-MDR, FDA cGMP).
• Understanding of capnography or gas sensing products, applications, and technologies a plus.
• Six Sigma (DFSS) Green Belt certification with actual project experience a plus.
• Solid OEM / ODM / CM experience.

Soft Skills:
• Leadership: The ability to make things happen by encouraging and channeling the contributions of others, recognizing and addressing important issues in a timely manner, and acting as an agent for change and continual improvement when required to achieve results.
• Accountability/Ownership: Work closely with team members and take ownership and deliver fast – educate and communicate to the team.
• Influence: The demonstrated ability to gain acceptance and commitment from other to one’s own beliefs and ideas.
• Negotiating: The ability to construct and maintain a strong bargaining position so as to ensure positive response and agreement: striving for win-win situations.
• Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
• Data-Driven Decision Making: the ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.


DUE TO BUDGET CONSTRAINTS: New Bill Rate will be $55-$60/hr


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