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Medical Device Compliance Engineer Jobs (NOW HIRING)

Agiliad

Medical Test Engineer

Boston, MA · On-site

Understanding of IEC 60601, ISO 13485, and medical device compliance standards. Qualifications: * BS/MS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering ...

Abbott

Software Compliance Engineer

Alameda, CA

This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate ...

Abbott

Software Compliance Engineer

Milpitas, CA

This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate ...

Abbott

Software Compliance Engineer

Alameda, CA · On-site

This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate ...

Abbott

Software Compliance Engineer

Milpitas, CA

This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate ...

Abbott

Software Compliance Engineer

Alameda, CA · On-site

This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate ...

Spherion Staffing Corporation

Be Seen First

Medical Device Assembler

Milpitas, CA · On-site

$25 - $27/hr

No cable building is required ● Compliance: Strictly follow cGMP and quality-driven procedures ... Read and interpret assembly drawings; use computers for basic programming, menu navigation, and ...

Bausch+Lomb Companies Inc.

$65K - $100K/yr

The Compliance Engineer II will provide technical support of Departmental Technical Documentation ... ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software ...

Bausch + Lomb

Compliance Engineer II

Rochester, NY · On-site

$65K - $100K/yr

The Compliance Engineer II will provide technical support of Departmental Technical Documentation ... ISO-9000, GMP, medical device manufacturing experience, technical writing, equipment and software ...

Spherion Staffing Corporation

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Medical Device Assembler

Milpitas, CA · On-site

$25 - $27/hr

No cable building is required ● Compliance: Strictly follow cGMP and quality-driven procedures ... Read and interpret assembly drawings; use computers for basic programming, menu navigation, and ...

Astrix Inc

Medical Device Assembler

Santa Rosa, CA · On-site

$19.75 - $24/hr

Pay Rate Low: 22 | Pay Rate High: 26 The Medical Device Assembler is responsible for assembling ... Work with supervisors, engineers, and technicians to resolve line issues and support process ...

Therakos

Medical Device Service Engineer

Madison, WI · On-site

Job Title Medical Device Service Engineer Requisition JR000015824 Medical Device Service Engineer ... Ensures compliance with the company quality system, in accordance with the applicable Code of ...

Marquee Staffing - OC

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1st Shift - Medical Device Assembler

Irvine, CA · On-site

$21 - $25/hr

Understanding and compliance with Good Manufacturing Practices (GMP) and Good Documentation ... Capability to read and interpret engineering drawings, specifications, and method sheets * Basic ...

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Medical Device Compliance Engineer information

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How much do medical device compliance engineer jobs pay per year?

As of Jun 13, 2026, the average yearly pay for medical device compliance engineer in the United States is $106,207.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,000.00 and $124,500.00 per year, depending on experience, location, and employer.

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

AspectMedical Device Compliance EngineerQuality Assurance Engineer
CertificationsISO 13485, FDA regulations, MDRISO 9001, Six Sigma, FDA regulations
Work EnvironmentRegulatory agencies, R&D, manufacturingManufacturing, product testing, process improvement
Industry UsageMedical device companies, regulatory bodiesVarious industries including medical devices, manufacturing

The Medical Device Compliance Engineer focuses on ensuring medical devices meet regulatory standards and compliance requirements, working closely with regulatory agencies. In contrast, the Quality Assurance Engineer emphasizes overall product quality, process improvements, and defect prevention across industries. Both roles require knowledge of industry standards and collaborate to ensure safe, effective products.

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

To thrive as a Medical Device Compliance Engineer, you need a solid background in engineering, regulatory affairs, and quality assurance, typically supported by a degree in engineering or a related field. Familiarity with standards like ISO 13485, FDA 21 CFR Part 820, and tools such as risk management software and document control systems is essential. Strong attention to detail, problem-solving abilities, and effective communication skills help you interpret regulations and collaborate across teams. These skills ensure that medical devices meet stringent regulatory requirements, safeguarding patient safety and enabling successful product launches.

What are Medical Device Compliance Engineers?

Medical Device Compliance Engineers are professionals responsible for ensuring that medical devices meet all regulatory standards and requirements before they reach the market. They work closely with design, manufacturing, and quality assurance teams to develop and implement processes that comply with regulations set by organizations like the FDA, ISO, and other international bodies. Their duties include reviewing technical documentation, conducting risk assessments, and liaising with regulatory agencies to ensure ongoing compliance throughout the product lifecycle.

What are some common challenges faced by Medical Device Compliance Engineers during product development?

Medical Device Compliance Engineers often face the challenge of keeping up with evolving international regulatory standards, such as FDA and EU MDR requirements, while ensuring that product development stays on schedule. Balancing thorough documentation and risk management with efficient project timelines can be demanding. Additionally, collaborating with cross-functional teams—like R&D, manufacturing, and quality assurance—requires clear communication to address compliance issues early and avoid costly redesigns. Staying proactive in identifying potential regulatory hurdles is key to success in this role.
More about Medical Device Compliance Engineer jobs
What cities are hiring for Medical Device Compliance Engineer jobs? Cities with the most Medical Device Compliance Engineer job openings:
What states have the most Medical Device Compliance Engineer jobs? States with the most job openings for Medical Device Compliance Engineer jobs include:
What job categories do people searching Medical Device Compliance Engineer jobs look for? The top searched job categories for Medical Device Compliance Engineer jobs are:
Medical Device Compliance Engineer jobs near you
Infographic showing various Medical Device Compliance Engineer job openings in the United States as of June 2026, with employment types broken down into 32% As Needed, 56% Full Time, 3% Part Time, 3% Temporary, 3% Contract, and 3% Nights. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $106,207 per year, or $51.1 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 6 days ago

Hikma Pharmaceuticals rating

7.8

Company rating: 7.8 out of 10

Based on 29 frontline employees who took The Breakroom Quiz

39th of 71 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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