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Medical Device Validation Engineer Jobs in Frederick, MD

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

CAI

Computer Systems Validation Engineer

Rockville, MD · On-site

$75K - $106K/yr

We provide commissioning, qualification, validation, startup, project management, and other ... medical device In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211 ...

Ametek

Sr. Mechanical Engineer

Germantown, MD · On-site

$106K - $140K/yr

LKC Technologies is seeking an experienced Senior Mechanical Engineer to join a collaborative ... and validation activities, including IQ, OQ, and PQ. * Strong understanding of medical device ...

Ametek

Sr. Mechanical Engineer

Germantown, MD · On-site

$106K - $140K/yr

LKC Technologies is seeking an experienced Senior Mechanical Engineer to join a collaborative ... and validation activities, including IQ, OQ, and PQ. * Strong understanding of medical device ...

Addison Group

Senior Staff Packaging Engineer

Leesburg, VA · On-site

$128K - $136K/yr

Senior Staff Packaging Engineer Location: Leesburg, VA (5-15% Travel) Compensation: $128,000 - $136 ... Medical device packaging design. * Sterile packaging systems. * Packaging validation and testing.

Addison Group

Senior Staff Packaging Engineer

Leesburg, VA · On-site

$128K - $136K/yr

Senior Staff Packaging Engineer Location: Leesburg, VA (5-15% Travel) Compensation: $128,000 - $136 ... Medical device packaging design. * Sterile packaging systems. * Packaging validation and testing.

Pinnaql

Senior Automation Engineer

Rockville, MD · On-site

$106K - $139K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Experience supporting automation projects in pharmaceutical, biotech, medical device, or other GMP ...

Ametek

Principal Software Engineer

Germantown, MD · On-site

$137K - $184K/yr

Medical device development experience, including familiarity with design controls, risk management ... validation, and regulatory requirements. * Experience working in regulated industries such as ...

Ametek

Principal Software Engineer

Germantown, MD · On-site

$137K - $184K/yr

Medical device development experience, including familiarity with design controls, risk management ... validation, and regulatory requirements. * Experience working in regulated industries such as ...

AMETEK, Inc.

Principal Software Engineer

Germantown, MD · On-site

$190 - $225/hr

Medical device development experience, including familiarity with design controls, risk management ... validation, and regulatory requirements. * Experience working in regulated industries such as ...

Pinnaql

Automation Project Manager

Rockville, MD

$96K - $126K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Experience supporting automation projects in pharmaceutical, biotech, medical device, or other GMP ...

Pinnaql

Automation Project Manager

Rockville, MD

$96K - $126K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Experience supporting automation projects in pharmaceutical, biotech, medical device, or other GMP ...

System One

Senior Mechanical Engineer II

Gaithersburg, MD · On-site

$113K - $150K/yr

Experience in medical device, bioprocessing, pharma, or regulated industries * Hands-on experience ... Experience with validation, testing, and engineering documentation * Prototyping and fabrication ...

System One

Senior Mechanical Engineer II

Gaithersburg, MD · On-site

$113K - $150K/yr

Experience in medical device, bioprocessing, pharma, or regulated industries * Hands-on experience ... Experience with validation, testing, and engineering documentation * Prototyping and fabrication ...

System One

Senior Mechanical Engineer II

Gaithersburg, MD · On-site

$113K - $150K/yr

Experience in medical device, bioprocessing, pharma, or regulated industries * Hands-on experience ... Experience with validation, testing, and engineering documentation * Prototyping and fabrication ...

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All JobsMedical Device Validation Engineer JobsMedical Device Validation Engineer Jobs in Frederick, MD

Medical Device Validation Engineer information

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How much do medical device validation engineer jobs pay per hour?

As of Aug 25, 2026, the average hourly pay for medical device validation engineer in Frederick, MD is $51.70, according to ZipRecruiter salary data. Most workers in this role earn between $39.18 and $62.84 per hour, depending on experience, location, and employer.

What does a medical device validation engineer do?

A Medical Device Validation Engineer is responsible for ensuring that medical devices meet regulatory and quality standards before they reach the market. They design and execute tests to validate that products perform as intended, documenting procedures and results to comply with industry regulations such as FDA and ISO guidelines. Their work involves collaborating with design, manufacturing, and quality assurance teams to identify risks and verify that devices are safe and effective for use. This role is crucial for patient safety and for a company's ability to market medical products globally.

What are the key skills and qualifications needed to thrive as a medical device validation engineer?

To thrive as a Medical Device Validation Engineer, you need a strong background in biomedical engineering or a related field, with expertise in validation protocols, regulatory compliance, and risk analysis. Familiarity with technical standards such as ISO 13485, FDA 21 CFR Part 820, and tools like statistical analysis software and validation management systems is essential. Attention to detail, problem-solving abilities, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills are crucial to guarantee that medical devices meet regulatory requirements, function safely, and reach the market efficiently.

What are some common challenges faced by medical device validation engineers during the validation process?

Medical Device Validation Engineers often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating cross-functional teams. Additionally, they must address unexpected technical issues that arise during testing and validation, and meticulously document results to meet quality and audit requirements. Effective communication and adaptability are crucial for successfully navigating these challenges and delivering safe, effective medical devices.

What is the difference between Medical Device Validation Engineer vs Quality Assurance Engineer?

AspectMedical Device Validation EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like CQE or validation-specific trainingEngineering or related degree, CQE or QA certifications
Work EnvironmentDesign validation, process validation, testing labsAudits, process improvements, compliance documentation
Industry UsageProduct development, validation phases in medical device manufacturingEnsuring overall product quality, compliance, and process control

The Medical Device Validation Engineer focuses on validating medical devices through testing and process validation, ensuring products meet regulatory standards. In contrast, the Quality Assurance Engineer oversees overall quality systems, audits, and compliance processes. Both roles require similar certifications and work within the medical device industry, but their core responsibilities differ in scope and focus.

What are popular job titles related to Medical Device Validation Engineer jobs in Frederick, MD?

For Medical Device Validation Engineer jobs in Frederick, MD, the most frequently searched job titles are:

What job categories do people searching Medical Device Validation Engineer jobs in Frederick, MD look for?

The top searched job categories for Medical Device Validation Engineer jobs in Frederick, MD are:

What cities near Frederick, MD are hiring for Medical Device Validation Engineer jobs?

Cities near Frederick, MD with the most Medical Device Validation Engineer job openings:

Medical Device Validation Engineer jobs near you

Validation Engineer I

Rockville, MD • On-site

Supernus Pharmaceuticals, Inc.
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Supernus Pharmaceuticals, Inc.external

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Job description

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.
Job Summary:
The Validation Engineer I supports activities within the Drug Delivery Sciences department related to process development, validation, and technology transfer. This role will develop, lead, and execute pre-validation studies and engineering activities. In addition, this role will partner with contract manufacturing organizations (CMOs) to support manufacturing scale up and operations readiness. Incumbents in this role will support in house formulation and process development, author sections of regulatory filing documents, and collaborate cross functionally to ensure timely delivery of clinical trial materials.
Essential Duties & Responsibilities:
  • Develops and conducts statistical analyses, including Design of Experiments (DOE) and Statistical Process Controls (SPC) to evaluate and improve manufacturing processes.
  • Leads pre-validation studies and engineering batches to identify and define critical process parameters of a process at Contract Manufacturing Organizations (CMO).
  • Write and review study protocols, technical reports, and validation documentation to ensure alignment with regulatory and quality standards.
  • Reviews and approves manufacturing batch records, protocols, and reports.
  • Supports process technology transfer to Contract Manufacturing Organization (CMO).
  • Assists with manufacturing scale-up manufacturing, process registration, and process validation activities at CMOs.
  • Recommends and implements equipment and manufacturing processes to ensure successful process technology transfer, process registration, and validation.
  • Writes and reviews of equipment qualification documents, Standard Operating Procedures (SOPs), and work instructions.
  • Collaborates cross functionally to support the manufacture of Clinical Trial Materials (CTM) and ensure the timely delivery to clinical programs.
  • Writes and reviews relevant quality sections of regulatory filing documents (IND, NDA, Briefing packages, IMPD, CTA, etc.).
  • Support early phase product and process development in collaboration with Drug Delivery Sciences teams.
  • Other duties as assigned.

Supervisory Responsibilities:
  • N/A.

Knowledge & Other Qualifications:
  • Bachelor's degree in engineering and a minimum of two years of relevant industry experience in manufacturing, process development, scale-up, technology transfer, or process validation.
  • Previous experience writing equipment validation protocols or technical writing.
  • Working knowledge of cGMP requirements related to Drug Product manufacturing processes.
  • Demonstrated ability to solve complex technical problems with the use of data.
  • Previous experience working with Statistical models and conducting statistical analyses a plus.
  • Strong written and verbal communication skills are required.
  • Proficiency with Microsoft office suite (Word, Excel, Outlook) required.

Other Characteristics:
  • Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
  • Ability to have an innovative and dynamic approach to work.
  • A self-starter able to work independently but comfortable working in a team environment.
  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
  • Capable of performing other duties as assigned by Management.
  • Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:
  • Sedentary work, when not working in the lab. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time.
  • When in the lab, employees will be required to exert up to approximately 50 pounds of force occasionally and/or up to 30 pounds of force frequently, as well as exerting up to 10 pounds of force constantly to move objects, when working in the lab.
  • The employee is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is also required to have the visual acuity to perform activities such as operating machines, and to perform mechanical or skilled trade tasks of a non-repetitive nature.
  • Will be required to work in a clean processing room environment occasionally and wear personal protective equipment to include but not limited to gloves, safety glasses or goggles, face shields, lab coats, ear plugs, half mask air purifying respirator, or powered air purifying respirator (PAPR) and Tyvek suits occasionally.
  • The employee is not substantially exposed to adverse environmental conditions on a regular basis. Employees may have to wear Tyvek suits when working in the lab, which can make conditions warmer, and more challenging. Employees will be required to work and exert force while wearing Tyvek suits.
  • Position may require prolonged sitting, prolonged standing, balancing, stooping, bending, kneeling, crouching, walking and pushing.
  • Travel will be project and phase dependent. Phase 2 or small-scale process technology transfers may require 20-40% of travel a month. Large-scale technology transfers, scale up, registration and validation may require 50-90% of travel a month.

Compensation:
At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $74,000 to $85,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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