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Medical Device Labeling Jobs (NOW HIRING)

Intellectt INC

Packaging Engineer

Boston, MA · On-site

Ensure compliance with medical device labeling requirements, including UDI (Unique Device Identification) * Implement and validate barcode systems in alignment with GS1 standards * Support regulatory ...

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How much do medical device labeling jobs pay per hour?

As of May 30, 2026, the average hourly pay for medical device labeling in the United States is $30.53, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $39.18 per hour, depending on experience, location, and employer.

What is a Medical Device Labeling job?

A Medical Device Labeling job involves creating, reviewing, and managing labeling content for medical devices to ensure compliance with regulatory requirements. This includes instructions for use, packaging labels, and safety information for healthcare professionals and patients. Professionals in this role collaborate with regulatory, quality, and engineering teams to meet industry standards and country-specific regulations. Their work ensures that medical devices are used safely and effectively, reducing risks associated with improper usage.

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

To thrive in Medical Device Labeling, you need a strong understanding of regulatory requirements (such as FDA and EU MDR), attention to detail, and experience with technical writing or documentation, often supported by a degree in life sciences or a related field. Familiarity with labeling management systems, document control tools, and knowledge of ISO standards are key technical qualifications, and certifications like RAC can be advantageous. Strong communication, collaboration, and organizational skills set candidates apart, as these roles often involve coordinating with cross-functional teams such as regulatory, engineering, and quality assurance. These capabilities ensure labeling materials meet strict compliance standards, avoid costly errors or recalls, and support timely product launch and patient safety.

What are the typical daily responsibilities for someone working in Medical Device Labeling?

Professionals in Medical Device Labeling are responsible for creating, reviewing, and updating product labels, instructions for use, and packaging materials to ensure compliance with regulatory standards. They often collaborate closely with regulatory affairs, engineering, and quality assurance teams to gather technical product information and incorporate feedback. Daily activities may also include managing document control processes, implementing labeling changes driven by new regulations or product updates, and preparing submissions for global markets. Attention to detail and the ability to manage multiple projects simultaneously are crucial for success in this role.
More about Medical Device Labeling jobs
What cities are hiring for Medical Device Labeling jobs? Cities with the most Medical Device Labeling job openings:
What are the most commonly searched types of Medical Device Labeling jobs? The most popular types of Medical Device Labeling jobs are:
What states have the most Medical Device Labeling jobs? States with the most job openings for Medical Device Labeling jobs include:
What job categories do people searching Medical Device Labeling jobs look for? The top searched job categories for Medical Device Labeling jobs are:
Medical Device Labeling jobs near you
Infographic showing various Medical Device Labeling job openings in the United States as of May 2026, with employment types broken down into 50% Full Time, and 50% Part Time. Highlights an 100% Physical job distribution, with an average salary of $63,493 per year, or $30.5 per hour.
Human Factors Engineer, Biopharma Medical Device - Remote (JP14424)

Human Factors Engineer, Biopharma Medical Device - Remote (JP14424)

3 Key Consulting

Thousand Oaks, CA • Remote

$70 - $80/hr

Other

Posted 14 days ago

Job description

Job Title:Human Factors Engineer, Biopharma Medical Device - Remote (JP14424)
Location:Thousand Oaks, CA 91320
Employment Type: Contract
Duration:1+ years with likely extensions and/or conversion to permanent
Posting Date:08/18/2025
Target start date:9/15/2025
Pay Rate:$70-80/hr W2 with benefits, or open to market rate DOE.
Note: This can be fully remote but local to Thousand Oaks, Ca is preferred.
3 Key Consulting is hiring aHuman Factors Engineerfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal Candidate: 7-10 years of practical human factors experience in medical devices or combination products. Hands-on implementation experience required.
Nice to Have: Experience with auto-injectors, human factors validation, and engagement with the FDA or global regulatory bodies.
Job Description:
Seeking a results-driven and experienced Human Factors / Usability Engineer (HF/UE) contractor to support the Human Factors Engineering (HFE) team within the broader Combination Product Optimization (CPO) function. This role is critical in ensuring company drug delivery systems and combination products meet the highest standards of usability, safety, and regulatory compliance.
This individual contributor will play a hands-on role across the product lifecycle, from early-stage user research through design input, usability testing, and preparation for FDA and global regulatory submissions. The ideal candidate will thrive in a fast-paced, matrixed environment and bring deep domain expertise in medical devices, combination products, and FDA-regulated usability engineering.
Responsibilities:
  • Human-Centered Design Integration: Partner cross-functionally with engineering, design, commercial, clinical, regulatory, and quality teams to translate user needs into product design, including user interface (UI) requirements, labeling, packaging, and instructions for use.
  • Usability Research Execution: Lead or support usability activities such as study design, protocol development, IRB submission, participant recruitment, data collection, moderation, analysis, and reporting for formative and summative studies.
  • Use Risk Mitigation: Conduct comprehensive task analyses, root cause investigations, and use-related risk analyses to inform product design and identify use-related risks.
  • Cross-Functional Influence: Serve as a key liaison between HFE and program team functional stakeholders to ensure human capabilities and limitations are reflected in product architecture and usability requirements, and human factors activities are considered at all stages of the product design lifecycle.
  • Regulatory Readiness: Support the creation of HF documentation for regulatory submissions including HFE protocols/reports, URRAs, and other components of the overall HF File, all in accordance with global standards and FDA guidance.
  • Stakeholder Engagement: Actively communicate and align with internal and external stakeholders to ensure user-centric solutions are embedded across development programs.

Top Must Have Skills:
  • Human Factors Engineering
  • Data Analysis
  • Technical Writing

Preferred Qualifications:
  • Advanced degree in Human Factors or Usability Engineering
  • Deep knowledge of applicable global guidance and standards:
    • FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, relevant device labeling standards
    • IEC/ISO: 62366, 14971, 13485
    • Other: HE:75, EU MDR Annex 1, additional relevant international device labeling and usability engineering standards
  • Proven track record supporting both formative and summative usability studies for combination products and injectors (e.g., pens, autoinjectors, on-body delivery systems)
  • Experience with early concept evaluations, use-risk analyses, and iterative design refinement
  • Demonstrated ability to influence technical design decisions with a deep understanding of user behavior and cognitive workload
  • Technical fluency across disciplines-capable of translating human factors insights for engineering, clinical, software, and regulatory audiences
  • Experience contributing to HF sections of FDA pre-submissions, IND/IDE, NDA, BLA, and global regulatory dossiers
  • Strong communication, critical thinking, and problem-solving skills in a collaborative environment
  • Able to manage ambiguity, prioritize competing deadlines, and drive user-centered design in a global organization

Red Flags:
  • No experience in human factors engineering in the medical device or combination product space.
  • Less than 5 years of relevant experience
  • No direct human factors hands on experience

Interview process:
2 rounds of interviews
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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