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Medical Device Validation Jobs (NOW HIRING)

Sterling Engineering, Inc.

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Medical Device Sales Representative

San Francisco, CA · Remote

$80K/yr

Valid U.S. driver's license and acceptable driving record Job Summary: The District Sales Manager ... Prior medical device, technical product, or travel sales experience a plus. * Experience building ...

Veterans Sourcing Group

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Quality Engineer Medical Device

Saint Paul, MN · On-site

$50 - $55/hr

... validation creation, and change assessments; communicate emerging issues and recovery action plans ... As well as Med device experience. Preferred: * Working knowledge of statistical methods, six sigma ...

Building Block Co

FL · On-site

Foot and Ankle Medical Device Sales Representative Position Overview: Are you thrilled by the ... A valid driver's license and vehicle to ensure your mobility and readiness to serve our clients.

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Medical Device Validation information

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$22

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How much do medical device validation jobs pay per hour?

As of Jun 28, 2026, the average hourly pay for medical device validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is medical device validation?

Medical device validation is the process of ensuring that a medical device consistently produces results that meet predetermined requirements and quality standards for its intended use. This involves rigorous testing and documentation to confirm that the device functions safely and effectively under real-world conditions. Validation is a critical step in regulatory approval and helps protect patient safety by verifying the device's performance and reliability. The process typically includes design validation, process validation, and software validation, depending on the type of device.

What are common challenges faced in a Medical Device Validation role and how are they typically addressed?

Professionals in Medical Device Validation often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating with cross-functional teams. Addressing these challenges typically involves staying current with industry regulations (like FDA or ISO standards), meticulous documentation practices, and frequent communication with engineering, quality assurance, and manufacturing teams. Proactive problem-solving, flexibility, and a detail-oriented mindset are essential for overcoming barriers and ensuring that devices meet safety and efficacy requirements before market release.

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

AspectMedical Device ValidationQuality Assurance Specialist
CertificationsISO 13485, FDA regulations, Validation protocolsISO 9001, GMP, FDA regulations
Work EnvironmentManufacturing, R&D, Regulatory complianceManufacturing, Quality control, Auditing
Primary FocusEnsuring devices meet specifications through testing and validationMaintaining quality systems and compliance

Medical Device Validation focuses on verifying that devices meet design and performance specifications through testing and validation processes. Quality Assurance Specialists oversee overall quality systems, ensuring compliance with standards and regulations. While both roles aim to ensure product safety and efficacy, Validation is more technical and testing-oriented, whereas QA is broader, covering system-wide quality management.

What are the key skills and qualifications needed to thrive as a Medical Device Validation Specialist, and why are they important?

To thrive as a Medical Device Validation Specialist, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA and ISO 13485), and experience in validation protocols. Familiarity with validation tools, statistical analysis software, and documentation systems is typically required, along with certifications like Six Sigma or CQE being advantageous. Strong attention to detail, analytical thinking, and effective communication are crucial soft skills for success in this role. These skills ensure that medical devices meet safety and quality standards, supporting compliance and protecting patient health.
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What cities are hiring for Medical Device Validation jobs? Cities with the most Medical Device Validation job openings:
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Medical Device Validation jobs near you
Infographic showing various Medical Device Validation job openings in the United States as of June 2026, with employment types broken down into 4% Locum Tenens, 1% Internship, 25% As Needed, 62% Full Time, 4% Part Time, and 4% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Sr. Engineer, Combination Products & Medical Device

Sr. Engineer, Combination Products & Medical Device

Hikma Pharmaceuticals PLC

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 21 days ago

Hikma Pharmaceuticals rating

8.0

Company rating: 8.0 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

37th of 73 rated pharmaceutical

Job description

Job Title: Sr. Engineer, Combination Products & Medical Device
Location: Columbus, OH
Job Type: Full time
Req ID: 11621
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Engineer, Combination Products & Medical Device to join our team.
In this role, you will be responsible for providing Combination Product and Medical Device Quality System Framework and Design expertise both within local operations and to drive best practices within the global organization.
Support includes ensuring that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site.
Responsibility also includes assessing, evaluating, identifying and implementing required documentation and studies to support requirements for launch, lifecycle changes and Business Development opportunities to meet identified business objectives and targets.
Key Responsibilities:
Knowledge Management
  • Stay up to date on regulations and regulatory trends to ensure that practices and procedures remain current with regulatory health authorities' expectations with regards to Combination Products and Medical Devices i.e. 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO14971, etc...
  • Supports Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed
  • Active member of relevant industry groups and key stakeholder organizations
  • Direct the work of consultants as needed and mentor others
  • Responsible for driving site education with regards to combination products and medical device requirements and organizational processes.

Infrastructure Support
  • Develop and ensure lifecycle management of a Quality Management System to be compliant with all relevant combination product and medical device regulations
  • Work within a Center of Excellence to share and align on best practices across Hikma Operating Units
  • Facilitate and/or supports the development and implementation of combination product and medical device quality governance processes and procedures
  • Develops and drives Risk Management approach
  • Contributes in relevant Quality Governance meetings

Project Support
  • Leads and/or participates on departmental and/or cross-functional teams as Combination Product and Medical Device SME
  • Performs gap assessments of processes and procedures against relevant device regulations
  • Develops recommendations and proposals to address identified gaps and provides expert guidance for projects
  • Drives, as appropriate, key activities such as risk analysis, FMEA and threshold analysis for active projects
  • Drive required Statements of Work with consultants where needed to support specific product programs e.g. device reliability, human factor studies, threshold analysis, FMEA, and/or risk analysis
  • Drives change control support for Combination Product & Medical Device requirements assessment and deliverable review
  • Provide support for relevant investigations and CAPA(s)
  • Provides guidance on approach and regulatory responses support for health authority questions to support product approvals
  • Other duties as assigned
  • Predictable, consistent onsite attendance required

Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
  • B.S. in engineering field (e.g. pharmacy, chemical, medical device, packaging or mechanical) with 10+ years direct experience at a medical device manufacturer or combination product manufacturer
  • M.S. in engineering field with 5+ years direct experience at a medical device manufacturer or combination product manufacturer

Business & Technical Expertise
  • Strong understanding of business development, lifecycle management, and long-term planning.
  • Subject matter expert in combination products and medical devices, including design controls, risk management, validation, reliability, and process controls.
  • Deep knowledge of pharmaceutical principles and complex dosage forms (e.g., nasal suspensions, dry powder inhalers, novel delivery systems).
  • Experienced in manufacturing, packaging, and device production processes.

Customer Focus
  • Champions quality and customer service excellence.
  • Aligns strategies to customer needs and market trends.
  • Establishes best practices to maintain industry-leading service standards.

Innovation & Change Leadership
  • Promotes a culture of innovation and continuous improvement.
  • Evaluates solutions against business goals and stakeholder impact.
  • Drives actionable strategies that enhance productivity and competitive advantage.

Communication & Influence
  • Effective communicator across diverse audiences; skilled in presentations, technical writing, and meeting facilitation.
  • Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Regulatory & Operational Excellence
  • Expert knowledge of pharmaceutical regulations (cGMP, FDA, DEA, ANDA requirements).
  • Strong project management experience leading cross-functional teams.
  • Able to work independently with minimal supervision.

Preferred Qualifications:
  • Experience with Class III/lifesaving combination products or medical devices; background in statistics and continuous improvement (Six Sigma Green/Black Belt preferred).
  • Strong critical thinking skills with a track record of completing complex projects and developing solutions to minimize risk and resolve issues.
  • Proven ability to manage multiple high-complexity projects, influencing cross-functional teams (PD, AD, DRA, Medical, QA, Operations, Warehouse) and external partners while meeting strict timelines.
  • Demonstrated decision-making capability, balancing risk vs. reward and independently driving tactical decisions (e.g., formulation, manufacturing processes, QbD strategy, experimental design).
  • Contributes to project planning, timelines, and budget adherence aligned with business goals.
  • Decisions primarily impact local operations with potential regional/global implications, including influence on regulatory timelines and product launch readiness.
  • Evaluates scientific and business risks to guide innovation and strategic direction.

What We Offer*:
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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