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Medical Device Product Development Jobs in Virginia

Addison Group

Senior Staff Packaging Engineer

Leesburg, VA · On-site

$128K - $136K/yr

Lead the design, development, and implementation of sterile and non-sterile medical device packaging systems from concept through production release. * Develop packaging design standards, engineering ...

Addison Group

Senior Staff Packaging Engineer

Leesburg, VA · On-site

$128K - $136K/yr

Lead the design, development, and implementation of sterile and non-sterile medical device packaging systems from concept through production release. * Develop packaging design standards, engineering ...

VB Spine

Sr. Development Engineer

Leesburg, VA · On-site

$100K - $110K/yr

Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline (Master's degree preferred) * 2+ years of product development experience (medical device ...

REHAU

Product Development Engineer

Leesburg, VA · On-site

$70K - $80K/yr

About the Role REHAU is seeking a Product Development Engineer to join our Water Technologies ... Medical, Dental, Vision, and Prescription coverage * PPO, HSA, and FSA options * Company-paid Life ...

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Medical Device Product Development information

What is a Medical Device Product Development job?

A Medical Device Product Development job involves designing, testing, and bringing medical devices to market while ensuring compliance with regulatory standards. Professionals in this role work with cross-functional teams, including engineering, regulatory affairs, and manufacturing, to develop safe and effective healthcare solutions. They oversee the entire product lifecycle, from concept and prototyping to clinical validation and commercialization. Strong knowledge of FDA, ISO, and other regulatory requirements is essential.

What are some typical challenges faced in Medical Device Product Development roles?

Professionals in Medical Device Product Development often encounter challenges such as navigating complex regulatory requirements, managing cross-functional project teams, and ensuring that products meet both clinical needs and quality standards. Balancing innovative design with safety and compliance can require careful planning and solid problem-solving skills. Additionally, adapting to shifting project timelines and incorporating stakeholder feedback are common aspects of the job. Overcoming these challenges is rewarding and helps ensure the delivery of safe, effective devices to patients and healthcare providers.

What are the key skills and qualifications needed to thrive in the Medical Device Product Development position, and why are they important?

To thrive in Medical Device Product Development, you need a strong background in engineering or life sciences, product design, and an understanding of regulatory requirements like FDA and ISO standards. Proficiency with CAD software, project management tools, and knowledge of quality management systems (QMS) is commonly required, along with certifications such as Six Sigma or PMP being beneficial. Strong problem-solving abilities, collaboration skills, and effective communication are key soft skills for this role. These skills are important to ensure that devices are developed safely, efficiently, and in compliance with industry regulations while fostering innovation and teamwork.

What are popular job titles related to Medical Device Product Development jobs in Virginia? For Medical Device Product Development jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Medical Device Product Development jobs in Virginia look for? The top searched job categories for Medical Device Product Development jobs in Virginia are:
What cities in Virginia are hiring for Medical Device Product Development jobs? Cities in Virginia with the most Medical Device Product Development job openings:
Medical Device Product Development jobs near you
Infographic showing various Medical Device Product Development job openings in Virginia as of July 2026, with employment types broken down into 57% Full Time, and 43% Contract. Highlights an 100% In-person job distribution.

Medical Device QMS Auditor

The British Standards Institution (BSI)

Reston, VA • On-site

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Re-posted 14 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: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH.
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 with extensive travel to medical device manufacutering sites. Candidate must be comfortable with overnight travel of 13-15 days out of every month.
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 (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 experience only 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.
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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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