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Medical Device Assessor Jobs (NOW HIRING)

Aerotek

Medical Device Assembler

Minneapolis, MN

$23 - $25/hr

... Medical device manufacturing experience Experience working in a cleanroom environment Why You'll ... AI helps assess applications and qualifications, but final decisions are made by our hiring team.

Aerotek

Medical Device Assembler

Santa Clara, CA

$21 - $26/hr

Hiring 5 Medical Device Assemblers for a Catheter Medical Device Company in Santa Clara, CA ... AI helps assess applications and qualifications, but final decisions are made by our hiring team.

Aerotek

Medical Device Assembler

Santa Clara, CA

$19 - $25/hr

Medical Device Assembler in Santa Clara, CA on the swing shift. Responsibilities * Assemble ... AI helps assess applications and qualifications, but final decisions are made by our hiring team.

Collabera

Medical device engineer

North Chicago, IL · On-site

... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Participate in project planning, design reviews and risk assessments using formal risk analysis ...

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Job Title: Medical Device QMS Auditor Location: Candidates must reside in one of the following ... Analyze and assess quality management systems with emphasis on design controls, manufacturing ...

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Medical Device Assessor information

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$32.5K

$75.3K

$125.5K

How much do medical device assessor jobs pay per year?

As of Jul 15, 2026, the average yearly pay for medical device assessor in the United States is $75,259.00, according to ZipRecruiter salary data. Most workers in this role earn between $46,000.00 and $97,000.00 per year, depending on experience, location, and employer.

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

A Medical Device Assessor requires a solid background in biomedical engineering, life sciences, or a related field, along with familiarity with regulatory standards such as ISO 13485 and MDR. Proficiency in using risk assessment tools, quality management systems, and technical documentation platforms is important, as well as certifications like RAC (Regulatory Affairs Certification) being advantageous. Attention to detail, analytical thinking, and effective communication are essential soft skills for excelling in this role. These skills are vital to ensure that medical devices meet strict safety, efficacy, and regulatory requirements, protecting patient health and supporting industry compliance.

What is a Medical Device Assessor job?

A Medical Device Assessor evaluates medical devices to ensure they meet regulatory standards for safety, performance, and compliance. They review technical documentation, assess clinical data, and conduct audits to verify adherence to regulations such as ISO 13485 and MDR. Assessors work for regulatory bodies, notified bodies, or consulting firms, helping manufacturers bring safe and effective devices to market. Their role is crucial in protecting public health by ensuring that medical devices perform as intended and pose minimal risk to users.

What are the typical daily responsibilities of a Medical Device Assessor?

As a Medical Device Assessor, your daily tasks often include reviewing technical documentation, assessing conformity to regulatory standards, and preparing detailed reports for manufacturers and regulatory bodies. You may also conduct audits, communicate with product development teams, and stay updated on evolving regulations. Collaboration with cross-functional teams, such as clinical experts and quality assurance professionals, is common to ensure all safety and efficacy criteria are met. The role requires balancing diligence in assessment with clear, actionable feedback to both internal and external stakeholders.

More about Medical Device Assessor jobs
What states have the most Medical Device Assessor jobs? States with the most job openings for Medical Device Assessor jobs include:
What job categories do people searching Medical Device Assessor jobs look for? The top searched job categories for Medical Device Assessor jobs are:
Medical Device Assessor jobs near you
Infographic showing various Medical Device Assessor job openings in the United States as of July 2026, with employment types broken down into 1% Locum Tenens, 1% As Needed, 74% Full Time, 6% Part Time, 4% Contract, and 14% Nights. Highlights an 89% Physical, 2% Hybrid, and 9% Remote job distribution, with an average salary of $75,259 per year, or $36.2 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

Re-posted 5 days ago

Hikma Pharmaceuticals rating

8.0

Company rating: 8.0 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

38th of 74 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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