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Manager Medical Device Software Engineer Jobs in Virginia

IVWATCH LLC

Embedded Software Engineer

Newport News, VA · On-site

Position Summary ivWatch is seeking an Embedded Software Engineer to design, develop, test, and maintain embedded software for our medical device products. This role will work closely with software ...

ivWatch LLC

Embedded Software Engineer

Newport News, VA · On-site

$75K - $82K/yr

Position Summary ivWatch is seeking an Embedded Software Engineer to design, develop, test, and maintain embedded software for our medical device products. This role will work closely with software ...

Cubic Corporation

Principal Software Engineer

Ashburn, VA · On-site

$120 - $180/hr

... management position as the team expands. The role involves designing embedded software for new ... device software, primarily in C and C++. Key Responsibilities * Lead software projects, ensuring ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

Complete the bulk download of documents and records from a Quality Management System. Required ... Experience in the medical device industry within Quality Assurance, Validation, Manufacturing ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

Complete the bulk download of documents and records from a Quality Management System. Required ... Experience in the medical device industry within Quality Assurance, Validation, Manufacturing ...

Alarm.com

Principal Software Engineer

Tysons Corner, VA · On-site

$135K - $182K/yr

... management, HVAC, water, and connected-device control experiences. This role is an IC role that ... The package includes medical plans with company subsidies, a Health Savings Account (HSA) with a ...

Alarm.com

Principal Software Engineer

Mclean, VA

$136K - $183K/yr

... management, HVAC, water, and connected-device control experiences. This role is an IC role that ... The package includes medical plans with company subsidies, a Health Savings Account (HSA) with a ...

Alarm.com

Principal Software Engineer

Arlington, VA · On-site

$155K - $208K/yr

... management, HVAC, water, and connected-device control experiences. This role is an IC role that ... The package includes medical plans with company subsidies, a Health Savings Account (HSA) with a ...

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All JobsMedical Device Software Engineer JobsManager Medical Device Software Engineer JobsManager Medical Device Software Engineer Jobs in Virginia

Manager Medical Device Software Engineer information

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

What are the most commonly searched types of Medical Device Software Engineer jobs in Virginia?

The most popular types of Medical Device Software Engineer jobs in Virginia are:

What are popular job titles related to Manager Medical Device Software Engineer jobs in Virginia?

For Manager Medical Device Software Engineer jobs in Virginia, the most frequently searched job titles are:

What job categories do people searching Manager Medical Device Software Engineer jobs in Virginia look for?

The top searched job categories for Manager Medical Device Software Engineer jobs in Virginia are:

What cities in Virginia are hiring for Manager Medical Device Software Engineer jobs?

Cities in Virginia with the most Manager Medical Device Software Engineer job openings:

Manager Medical Device Software Engineer jobs near you
Infographic showing various Manager Medical Device Software Engineer job openings in Virginia as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, and 5% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Client Manager - Medical Device QMS Auditor

Reston, VA • On-site

The British Standards Institution (BSI)
See more jobs at The British Standards Institution (BSI)external

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Posted 15 days ago

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!
Job Title: Medical Device QMS Auditor
Location: Colorado
BSI (British Standards Institution) is the global business standards company that equips businesses with the solutions to turn standards of best practice into habits of excellence.
Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.
This is a travel-based position requiring extensive travel to medical device manufacturing sites, including approximately 13-15 overnight travel days per month.
Purpose of role: to conduct various types of audits and work closely with clients to help them improve their performance by assessing their systems and processes against BSI standards.
Essential Responsibilities
  • Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
  • Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
  • Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
  • Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
  • Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications
  • Technical degree (Associate's, Bachelor's, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
  • Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit only experience is insufficient.
  • Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
  • Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR, are a plus.

Core Competencies
  • Strong verbal and written communication skills, and attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Self-motivated, flexible, and excellent time management/planning skills.
  • Willingness to travel extensively.
  • Enthusiastic, committed team player.
  • Business development and public speaking skills are considered advantageous.

Preferred Qualifications
  • Experience with process validation, equipment qualification, and manufacturing process development.
  • Experience in design and development activities, including design controls and design transfer.
  • Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
  • Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
  • Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
  • Experience leading hands-on teams in manufacturing, testing, or validation.
  • Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
  • Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
  • Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
About Us
BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

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