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Principal Software Engineer

(Medical Device Industry - Only)

READ FIRST! HARD REQUIREMENTS/ NON-NEGOTIABLES:

MUST have 8+ years of software development experience in the medical device industry (Master’s degree may substitute for one (1) year of experience.)
MUST have 5+ years of embedded or application software development for medical devices
No H1B Visa Sponsorship
Must be able local to the Irvine, CA area, no relocation support
Must have a BS in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or equivalent
MUST have strong C/C++ skills for firmware development

IF YOU MEET ALL SIX (6) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:

About the Role:

Our Client is seeking a seasoned Principal Software Engineer to lead the development of our software products—from mobile apps and web frontends to backend systems. In this role, you’ll guide software architecture, drive integration efforts, and ensure our development processes meet medical device regulatory standards. The ideal candidate possesses extensive experience in application and embedded software development, as well as expertise in Android and iOS platforms, test frameworks, and regulatory-compliant practices for medical devices.

Essential Duties and Responsibilities:

Primary contributor in defining the Client’s software architecture and leading software development across all software platforms.
Collaborate with Quality Engineers to develop and implement robust and efficient testing strategies, supporting risk management efforts for all software applications.
Evaluate compliance and ensure that software and firmware development align with IEC 62304, FDA, ISO 13485, ISO 14971, and other regulatory standards governing medical devices.
Oversee the development of testing strategies (Unit/Integration) and Design Verification protocols to verify software/firmware functionality post-acquisition.
Support software/ firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing, and PMO, to ensure seamless device integration.
Establish and document software development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS). Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
Establish best practices for software/firmware development, including coding guidelines, code reviews, and adherence to internal QMS.
Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.

Education and/or Work Experience Requirements:

B.S or higher in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or related major.
8+ years of experience in software development. (Master’s degree may substitute for one year of experience.)
5+ years in embedded or application software development for medical devices.
Sound knowledge of software engineering principles and practices, such as object-oriented and API principles.
Experience in developing mobile applications in an FDA-regulated environment or other regulated industry.
Strong C/C++ skills for firmware development.
Hands-on experience and knowledge in software applications utilizing BLE stacks and BLE API on mobile platforms.

Additional Requirements:

Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can do” attitude and ability to work well under pressure.
Strong organizational and multitasking skills, with a high level of attention to detail and a proactive approach to problem-solving.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with Microsoft Teams is a plus.
Prior startup experience preferred but not required.

Bonus Points:

Prior startup or early-stage company experience.
Familiarity with Microsoft Teams.

Physical Requirements:

Must be able to lift up to 20 lbs.
Must be able to work extended amounts of time standing or sitting based on projects and priorities.

Senior Product Quality Engineer – NPI

(Medical Device Industry - Only)

READ FIRST! HARD REQUIREMENTS/ NON NEGOTIABLES:

MUST have 7+ years of Quality Engineering experience in the medical device industry
No H1B Visa SponsorshipMust be able local to the Irvine, CA area, no relocation support
Must have a BS in Engineering, Physical Sciences or equivalent

IF YOU MEET ALL FOUR (4) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:

About the Role:

We are seeking a skilled and experienced Senior Product Quality Engineer – NPI to join our Client's team. The ideal candidate will have a minimum of 7 years of quality engineering experience with an emphasis on NPI and Sustaining Engineering in the medical device industry. This role is critical to ensuring the performance, reliability, and sustainability of all devices manufactured by the client.

Essential Duties and Responsibilities:

Participate in design and manufacturing reviews.
Generate DFMEAs/UFMEAs and participate in risk analysis discussions.
Develop inspection strategy and methods to support the development and launch of new products.
Review and approve design and development documentation.
Serve as subject matter expert for design quality in ISO and FDA audits.
Author procedures and work instructions that define and govern the quality system.
Conduct internal audits of the quality system and other business functions.
Evaluate nonconforming material and disposition based on cross-functional engineering review.
Assure compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD).
Review trends in device failures associated with customer complaints and nonconforming material.
Lead and own corrective and preventive actions and complaint investigations.
Work on complex special projects as assigned.

Education and/or Work Experience Requirements:

Bachelor's degree in Engineering or Physical Sciences is required.
7+ years of experience in the medical device industry.
Proficient in technical report writing and review.
Experience with design controls, risk management, statistics, test method validation, and new product development processes.
Experience with industry regulations such as ISO13485 and FDA QSR’s.
Advanced knowledge of ISO 14971 and risk management principles.

Additional Requirements:

Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure.
Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

Bonus Points:

Prior startup or early-stage company experience.
Familiarity with Microsoft Teams.

Physical Requirements:

Must be able to lift up to 20 lbs.
Must be able to work extended amounts of time standing or sitting based on projects and priorities.

Industry

Medical Equipment Manufacturing

Employment Type

Full-time

Senior Quality Engineer – Design Assurance

(Medical Device Industry - Only)

READ FIRST! HARD REQUIREMENTS/NON NEGOTIABLES:

MUST have 7+ years of Design Quality Assurance Engineering experience in the medical device industry
No H1B Visa Sponsorship
Must be able local to the Irvine, CA area, no relocation support
Must have a BS in Engineering, Physical Sciences or equivalent

IF YOU MEET ALL FOUR (4) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:

About the Role:

We are seeking a skilled and experienced Senior Quality Engineer – Design Assurance to join our team. The ideal candidate will have a minimum of 7 years of quality engineering and design assurance experience in the medical device industry. This role is critical to ensuring the performance, reliability, and sustainability of all devices manufactured by our Client.

Essential Duties and Responsibilities:

Fulfill design assurance role on new product development (conception to launch) and sustaining projects.
Complete planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
Support Regulatory Affairs with creating submissions and responding to submission questions.
Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
Continued support and optimization of DA centric New Product Development deliverables and processes.
Participate and lead New Product Development Phase Reviews and Design Reviews.
Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
Create and support the development and validation of new test methods.
Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
Develop the strategy and manage the execution of design verification and validation.
Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
Develop, execute, and manage First Article inspections.
Provide direction to design assurance engineering technicians supporting assigned projects.
Support improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
Support regulatory approvals and responses to regulatory questions.
Support Sustaining Engineering for design and process changes to commercialized product.
Support the transfer of new product development projects from development to production.
Support internal and external audits.

Note: 50% of this job involves direct R&D activities.

Education and/or Work Experience Requirements:

Bachelor's degree in Engineering or Physical Sciences is required.
7+ years of experience in the medical device industry.
Proficient in technical report writing and review.
Experience with design controls, risk management, statistics, test method validation, and new product development processes.
Experience with industry regulations such as ISO13485 and FDA QSR’s.

Additional Requirements:

Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure.
Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving.
Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

Bonus Points:

Prior startup or early-stage company experience.
Familiarity with Microsoft Teams.

Physical Requirements:

Must be able to lift up to 20 lbs.
Must be able to work extended amounts of time standing oc

Manufacturing Technicians

(Medical Device Industry - Only)

READ FIRST! HARD REQUIREMENTS/NON-NEGOTIABLES:

MUST have 5+ years of Manufacturing experience in the medical device industry
MUST have a High School diploma
No H1B Visa Sponsorship
Must be able local to the Irvine, CA area, no relocation support
Must be authorized to work in the United States and provide authorization evidence

IF YOU MEET ALL FOUR (4) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:

About the Role:

We are seeking a skilled and experienced Manufacturing Technicians to join our Client's team. The ideal candidate will have a minimum of 5 years of hands-on manufacturing experience in the medical device industry. This role is critical to ensuring the quality of all devices manufactured by the client.

Education and/or Work Experience Requirements:

High School Diploma is required.
5+ years of Manufacturing experience in the medical device industry.

Bonus Points:

Prior startup or early-stage company experience.

Physical Requirements:

Must be able to lift up to 20 lbs.
Must be able to work in a cleanroom environment all day
Must be able to work extended amounts of time standing or sitting based on projects and priorities.

Apply Here