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Medical Device Software Quality Engineer Jobs (NOW HIRING)

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R&D Engineer Sr.

Alameda, CA · On-site

$100K - $136K/yr

Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering ...

Nova Biomedical

Software Engineer Manager

Norwood, MA · On-site

The Software Engineer Manager will also help bring biotechnology software development capabilities ... medical device quality system procedures. * Guide the design, development, testing, integration ...

Tandemdiabetes

Serves as the Software Quality Assurance Engineer supporting software product development programs ... Knowledge of medical device software development processes, including mobile, embedded, and web ...

Heartflow

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

... Software as a Medical Device (SaMD) and AI/ML-enabled technologies-are safe, secure, and compliant ... ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt.

Socket.dev

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

... Software as a Medical Device (SaMD) and AI/ML-enabled technologies--are safe, secure, and compliant ... ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt.

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Medical Device Software Quality Engineer information

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How much do medical device software quality engineer jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for medical device software quality engineer in the United States is $48.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.22 and $55.53 per hour, depending on experience, location, and employer.

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For Medical Device Software Quality Engineer jobs, the most frequently searched job titles are:

Infographic showing various Medical Device Software Quality Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $100,970 per year, or $48.5 per hour.

Senior Quality Engineer I - Software

Monrovia, CA • On-site

Staar Surgical Company
Medical Equipment and Supplies Manufacturing • 201 - 500 employees
Learn more about Staar Surgical Companyexternal

$115K - $150K/yr

Full-time

Re-posted 13 days ago

Job description

MAIN JOB RESPONSIBILITIES / COMPETENCIES
1.Coordinate quality engineering activities supporting the Software as a Medical Device (SaMD), Quality System software, and Manufacturing software platforms to achieve business objectives.
2.Provide technical expertise through the software lifecycle, with a focus on SaMD, in the following areas: design control, risk analyses, verification/validation strategy, maintenance and change management.
3.Develop strategy as part of cross-functional teams to support the compliant and effective release of SaMD and other software applications.
4.Provide guidance and leadership on development / review of design control and validation policies and procedures, and resolutions to quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
5.Provide technical expertise to the risk documentation process.
6.Provide guidance and leadership on investigations involving software nonconformances, product or component failures, or customer complaints by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA.
7.Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
8.Provide guidance and leadership on design processes and site engineering functions to identify critical parameters and improve process quality.
9.Participate on Design Control New Product development teams; advise the team on design control requirements; develop, review and approve design control deliverables related to quality engineering and validations.
10.Other duties as assigned.

REQUIREMENTS

EDUCATION & TRAINING
Bachelor's degree, preferably in Engineering or sciences.
Advanced degree preferred.
Certified Quality Engineer (CQE) or equivalent preferred

EXPERIENCE
Five years' experience in validation and/or design control in the medical device software industry, including the practical application of FDA Quality System Regulation and ISO 13485; or equivalent combination of education/experience.
Experience in medical device software change management required.
Experience in vision care or intraocular lens industry preferred.
General knowledge of medical device software requirements (IEC 62304, IEC 82304) required.
Knowledge of international/ISO standards on ophthalmology preferred
Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.
SKILLS
Experience in writing technical documents, especially compliance and/or validation/quality assurance documents and protocols required.
Proficiency in written and spoken English required.
Excellent project management, organization, writing, communication and presentation skills required.
Ability to communicate in a wide variety of communication styles and to influence and build consensus across cross-functional groups.
Must have strong written and oral communication skills.

Pay range: $115K - $150K - Final compensation/salary will depend on experience.

STAAR Surgical is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.. #USA

Employment Type: Full time

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