Gilero | Software Quality Engineer for Embedded Systems | durham, nc
6 days ago
Are you passionate about using cutting-edge technology to improve lives? As a Software Quality Engineer for Embedded Systems at Gilero, you'll play a crucial role in ensuring the quality of life-saving medical devices and combination products. This is a unique opportunity to grow your expertise in software verification, validation, and compliance while working with advanced systems and embedded technologies.
Join us in a collaborative and innovative environment where your contributions will make a real difference. You'll work with multiple clients across a variety of cutting-edge products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.
You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus on software interface requirements, embedded systems, and Data Integrity across the organization in alignment with the quality system.
Responsibilities:
- As the Embedded Systems expert, you will lead software verification and validation activities for development products including review and approval of software test case protocols and reports, software development plans, and other system and software documentation required to establish software requirements.
- Author/review software and design history file required documents from a Quality oversight perspective.
- Perform risk evaluation and associated activities related to software development including FMEA, product risk analysis, and mitigation.
- Prepare documentation for IEC 60601-1 and IEC 62304 compliance
- Lead non-product software validation assessing the need for validation and preparing test scripts, executing protocols, and writing reports.
- Identify and implement improvements to the Quality Management System, validation master planning, software development lifecycle and testing practices within the company. Develop policies for management and assessment of non-product software releases.
- Oversee company compliance to 21CFR Part 11 compliance and data integrity policies. Act as company Data Integrity Officer.
- Execute quality event initiation, investigation, and closure for nonconformance's, CAPA, change control and complaints. Perform effectiveness checks.
- Perform equipment process validations (IQ/OQ), as applicable, including test or other equipment utilizing software, user controls and data management.
- Support internal and external audits.
Skills/Qualifications:
Minimum:
- Work onsite in Durham, NC 3 days a week
- US Citizen or Green card holder
- Bachelor's degree in engineering, science, or relevant field
- 5 years of embedded systems experience with a passion and thirst to learn more
- 5 years in a regulated manufacturing and/or development environment
- Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and combination product development and manufacturing
- Experience with IEC 60601-1, IEC 62304, and FDA software development guidelines
- Experience using risk analysis and continuous improvement concepts
- Extensive experience with GxP requirements
- Strong technical written and verbal communication skills
- Experience leading and/or supporting audits
Preferred:
- Master's or advanced degree in a relevant field
- 5+ years in pharma or medical device manufacturing and/or development environment
- Excellent interpersonal, change management, planning, and organizational skills
- Software lifecycle management experience in phase-appropriate environments ranging from pre-clinical to commercial
- Project management experience
- CQE ASQ or related certification
Personal Attributes:
- Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
- Productive in a fast-paced, entrepreneurial environment
- Commits to excellence and quality service to external and internal customers
- Adheres to established policies and procedures, while contributing to continuous improvements
Benefits: You will enjoy an annual bonus, Medical (3 BCBS plans to choose from), Guardian dental and vision, short-term and long-term disability, 401K with 5% match the first month you start with a zero vesting period.
-
Durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? As a Software Quality Engineer for Embedded Systems at Gilero, you'll play a crucial role in ensuring the quality of life-saving medical devices and combination products. This is a unique opportunity to grow your expertise in software verification, validation, and compliance while...
-
Manager, Software
3 weeks ago
durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
Manager, Software
4 weeks ago
Durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
Manager, Software
4 weeks ago
durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
Manager, Software
3 weeks ago
Durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
durham, United States Gilero, A Sanner Group Company Full timeThe work we do at Gilero matters. We’ve created a culture centered around creating medical devices that can help people. Knowing we’re participating in device solutions for things like opioid abuse, home dialysis, pain and fear associated with needle injections, and the safest, most accurate IV pump for the smallest patients, is what keeps us so...
-
Manager, Software
3 weeks ago
Durham, NC, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
Manager, Software
1 month ago
durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
Manager, Software
1 month ago
Durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
Manager, Software
1 month ago
durham, United States Gilero Full timeAre you passionate about using cutting-edge technology to improve lives? Join Gilero as a Software and Systems Development Manager and lead the charge in developing embedded software development solutions that will help save and improve lives. This role offers a unique opportunity to elevate your skills in embedded software while working with leading...
-
IT System Support Specialist
17 hours ago
Durham, United States Gilero, A Sanner Group Company Full timeThe work we do at Gilero matters. We’ve created a culture centered around creating medical devices that can help people. Knowing we’re participating in device solutions for things like opioid abuse, home dialysis, pain and fear associated with needle injections, and the safest, most accurate IV pump for the smallest patients, is what keeps us so...
-
Specialized Recruiting Group
1 week ago
durham, United States Specialized Recruiting Group - Raleigh-Durham, NC Full timeSpecialized Recruiting Group is seeking a technically-minded Project Manager for an immediate start with a local government branch in Durham, NC.As a Project Manager, you will utilize your leadership and creative problem-solving to shepherd requisitions through the procurement and implementation processes. Previous experience in state or local government...
-
Embedded Software Engineer
4 weeks ago
Durham, United States Actalent Full timeNEW EMBEDDED ENGINEERING OPPORTUNITY SUPPORTING THE DEVELOPMENT OF LARGE RENEWABLE ENERGY RESOURCES FOR A TOP SUSTAINABILITY COMPANY IN THE COUNTRY!!! JOB DESCRIPTION: We are hiring an Embedded Software Engineer to support clean energy transition enabling rapid deployment and efficient management of large-scale battery storage systems. As a Software...
-
durham, United States Insight Global Full timeDescription: Insight Global is partnered with one of their large pharmaceutical clients in hiring for an Building Engineer in Durham, NC. This position will be hired as a full-time position and will require onsite work in Durham, NC 27709.Requirements:10+ years of experience working with HVAC utilitiesExperience working with large-scale equipment (chillers,...
-
Kitchen Team Lead
4 weeks ago
Durham, North Carolina, United States 21c Museum Hotel Durham Full timeExecutive Chef Opportunity21c Museum Hotel Durham, a unique blend of boutique hotel and contemporary art museum, is seeking an experienced Line Cook to join our culinary team.About the RoleThis is an exceptional opportunity for a skilled cook who is passionate about delivering exceptional dining experiences to our guests. As a Line Cook, you will be...
-
durham, United States Fidelity TalentSource LLC Full timeSoftware Engineer in Test Fidelity TalentSource is your destination for discovering your next temporary role at Fidelity Investments. We are currently sourcing for a Software Engineer in Test to work in Fidelity’s Workplace Investing business unit in Durham, NC. This is an exciting new role within the Workplace Investing (WI) Data Engineering space and...
-
durham, United States Fidelity TalentSource LLC Full timeSoftware Engineer in Test Fidelity TalentSource is your destination for discovering your next temporary role at Fidelity Investments. We are currently sourcing for a Software Engineer in Test to work in Fidelity’s Workplace Investing business unit in Durham, NC. This is an exciting new role within the Workplace Investing (WI) Data Engineering space and...
-
Software Engineer
3 weeks ago
Durham, United States Actalent Full timeSoftware Engineer - Full Stack (User Interface) Hybrid in Durham, NC Our client is a leading integration services and software technology provider for utility-scale energy storage solutions in the United States and globally. The company’s clients and partners include the most technically and commercially demanding developers, utilities, renewable energy,...
-
Software Engineer
4 weeks ago
Durham, United States A-Line Staffing Solutions Full timeTitle: Software Engineer III Location: Durham, NC (Hybrid) – occasional travel to company work sites may be required Schedule: Mon – Fri, 8:00AM – 5:00PM EST Note: This role is NOT open to C2C candidates For certain roles at this client, assignment may be contingent upon the employer of record’s receipt of sufficient proof of full vaccination...
-
Geographic Information Systems Analyst
4 weeks ago
Durham, United States Specialized Recruiting Group - Raleigh-Durham, NC Full timeSpecialized Recruiting Group is hiring a GIS Analyst for a full-time contract position with the local municipal government in Durham, NC. As a GIS Analyst you would provide Geographic Information Systems (GIS) services and support by creating GIS Web applications; gathering, field-verifying, and distributing data; creating custom maps; and installing,...
