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Director Engineering Medical Device Jobs in Raleigh, NC

Eisai, Inc.

Mgr., Product Complaints (Hybrid)

Raleigh, NC · On-site

$104K - $137K/yr

FDA Medical Device Reporting (21 CFR Part 803) * EU MDR vigilance and complaint handling requirements * ISO 14971 risk management principles * IEC 62366-1 usability engineering * Strong cross ...

Merz North America

Senior Electrical Engineer

Raleigh, NC

$95K - $123K/yr

Provide electrical and firmware engineering support ensuring current and new products meet Medical Device safety requirements such as IEC 60601 and other Medical Device standards. * Ensure duties are ...

Eisai

Mgr., Product Complaints (Hybrid)

Raleigh, NC · Hybrid

$104K - $137K/yr

FDA Medical Device Reporting (21 CFR Part 803) * EU MDR vigilance and complaint handling requirements * ISO 14971 risk management principles * IEC 623661 usability engineering * Strong cross ...

Spectrum Staffing Services

Be Seen First

Quality Engineer

Raleigh, NC · On-site

$43 - $45/hr

... Medical Device, Engineering, Insurance and Business Operations placement. STAFFING OPTIONS: Spectrum offers a number of staffing options including, Direct Hire, Contract, Temp, Retained Search ...

Merz North America

Senior Electrical Engineer

Raleigh, NC · On-site

$95K - $123K/yr

Provide electrical and firmware engineering support ensuring current and new products meet Medical Device safety requirements such as IEC 60601 and other Medical Device standards. * Ensure duties are ...

NIRSense Inc

Principal Electrical Engineer

Morrisville, NC · On-site

$130K - $159K/yr

Demonstrated ability to independently lead and deliver complex medical device hardware development ... S. in Electrical or Biomedical Engineering or a related field. Preferred Qualifications:

NIRSense Inc.

Principal Electrical Engineer

Morrisville, NC · On-site

$130K - $159K/yr

Demonstrated ability to independently lead and deliver complex medical device hardware development ... S. in Electrical or Biomedical Engineering or a related field. Preferred Qualifications:

Varsity Tutors

Biomedical Engineering Tutor

Raleigh, NC · Remote

$18 - $40/hr

Ability to explain signal processing for biosignals, finite element analysis, drug delivery systems, and medical device design principles while preparing students for biomedical engineering ...

Varsity Tutors

Biomedical Engineering Tutor

Durham, NC · Remote

$18 - $40/hr

Ability to explain signal processing for biosignals, finite element analysis, drug delivery systems, and medical device design principles while preparing students for biomedical engineering ...

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All JobsEngineering Medical Device JobsDirector Engineering Medical Device JobsDirector Engineering Medical Device Jobs in Raleigh, NC

Director Engineering Medical Device information

See Raleigh, NC salary details

$71K

$189.3K

$246.9K

How much do director engineering medical device jobs pay per year?

As of Jul 16, 2026, the average yearly pay for director engineering medical device in Raleigh, NC is $189,273.00, according to ZipRecruiter salary data. Most workers in this role earn between $137,500.00 and $245,900.00 per year, depending on experience, location, and employer.

What are the typical challenges faced by a Director of Engineering in the medical device industry?

A Director of Engineering in the medical device field often navigates complex regulatory requirements while balancing innovation and speed-to-market. They frequently manage cross-functional teams, oversee rigorous testing and verification processes, and must ensure that all products meet strict quality and safety standards. Collaboration with regulatory, clinical, and marketing teams is essential to align technical development with business objectives. Additionally, adapting to evolving technology and changes in regulatory landscapes can present ongoing challenges, making strong leadership and adaptability key assets.

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

To excel as a Director Engineering Medical Device, you need extensive experience in engineering management, regulatory compliance (such as FDA and ISO standards), and a background in medical device design or related technical fields. Proficiency with product lifecycle management (PLM) tools, design control systems, and quality management certifications like Six Sigma or PMP are highly valuable. Outstanding leadership, strategic thinking, and the ability to communicate effectively across multidisciplinary teams help set top performers apart. These capabilities are crucial to successfully guide high-stakes projects, ensure regulatory compliance, and drive innovation in a highly regulated industry.

What is a Director Engineering Medical Device job?

A Director of Engineering in the medical device industry leads the design, development, and testing of medical technologies while ensuring compliance with regulatory standards. They manage engineering teams, oversee project timelines, and collaborate with cross-functional departments, including R&D, quality assurance, and manufacturing. Their role involves strategic planning, resource allocation, and risk management to drive innovation and bring safe, effective medical devices to market.

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What cities near Raleigh, NC are hiring for Director Engineering Medical Device jobs? Cities near Raleigh, NC with the most Director Engineering Medical Device job openings:
Director Engineering Medical Device jobs near you
Infographic showing various Director Engineering Medical Device job openings in Raleigh, NC as of July 2026, with employment types broken down into 66% Full Time, 17% Part Time, and 17% Contract. Highlights an 92% In-person, and 8% Remote job distribution, with an average salary of $189,273 per year, or $91 per hour.
Mgr., Product Complaints (Hybrid)

Mgr., Product Complaints (Hybrid)

Eisai, Inc.

Raleigh, NC • On-site

$104K - $137K/yr

Full-time

Re-posted yesterday

Job description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Manager, Product Complaints is responsible for the oversight, governance, and continuous improvement of Eisai's medical device complaint handling process. This role ensures that medical device complaints are consistently captured, appropriately triaged, thoroughly reviewed, and closed in compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR, and Eisai quality system requirements.
The role serves as the single point of entry for all Raleigh site commercial product complaints to ensure data quality and consistency; however, the position only triages and fully manages medical device complaints. This role is accountable for reviewing, challenging, accepting, and approving investigations from the device manufacturer on behalf of Eisai.
This role partners closely with medical information by providing high-quality medical device complaint data, accepted investigation outcomes, and trend analyses to support vigilance and signal management activities as part of the Post-Market Surveillance program (PMS).
Essential Functions:
  • Serve as the single point of entry for all Raleigh site product complaints, ensuring timely, accurate, and complete complaint documentation while following established Eisai procedures for routing all complaints.
  • Triage and classify medical device complaints, including confirmation of device involvement, user error considerations, and potential quality or safety impact.
  • Own and oversee the end-to-end lifecycle of medical device complaints, including intake, triage, investigation oversight, escalation, documentation, and closure. Apply human factors and usability engineering principles to assess whether events are attributable to user error, use related risk, foreseeable misuse, or product quality/design issues.
  • Manage complaint sample handling (shipping, tracking) to external sites for investigation.
  • Review investigation strategies, failure analysis methodologies, root cause determinations, and supporting evidence to ensure investigation adequacy, scientific rigor, and regulatory compliance.
  • Escalate inadequate, delayed, or non-compliant investigations through Quality governance and supplier oversight mechanisms.
  • Establish and monitor medical device complaint metrics, dashboards, and trend analyses (e.g., failure mode, component, lot/batch, time to event).
  • Ensure complaint data effectively informs CAPA, risk management, and product improvement initiatives.
  • Author, own, and maintain SOPs related to Complaint Handling and Oversight
  • Drive continuous improvement initiatives related to complaint handling effectiveness, investigation quality, and compliance.

Requirements:
  • Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Pharmacy, or a related technical field.
  • 5+ years of experience in medical device complaint handling, post market quality, or related quality system roles, required.
  • Medical Device (auto-injector) and combination product experience required.
  • Experience providing oversight of externally performed medical device investigations (e.g., CMOs or device manufacturers) preferred.
  • Hands-on experience with complaint systems compliant with 21 CFR Part 820 (QMSR), ISO 13485, and EU MDR.
  • Prior involvement in medical device recalls or field actions preferred.
  • Strong knowledge of:
    • FDA Medical Device Reporting (21 CFR Part 803)
    • EU MDR vigilance and complaint handling requirements
    • ISO 14971 risk management principles
    • IEC 62366-1 usability engineering
  • Strong cross functional collaboration and stakeholder influence skills.
  • Excellent organizational, time management, and technical writing capabilities.
  • Values aligned with Eisai's mission and patient first culture, including integrity, professionalism, quality, and teamwork.
  • Ability to work a hybrid schedule (a minimum of 3 designated days - T, W, TH - onsite)

Eisai Salary Transparency Language:
The annual base salary range for the Mgr., Product Complaints (Hybrid) is from :$104,900-$137,700
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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About Eisai

Sourced by ZipRecruiter

Eisai is a global pharmaceutical company (headquartered in Woodcliff Lake, NJ, US), renowned for its innovative research and development in neuroscience and oncology. The primary focus of the company is to provide therapeutic treatments and solutions for diseases like Alzheimer's, cancer, and other neurological disorders. Eisai was founded in Japan in 1941 and has since developed a strong presence across international markets. Eisai's core values center around their philosophy of 'human health care' (hhc), where they aim to make significant and positive contributions to patients and their families' healthcare worldwide.

Company size

1,001 - 5,000 Employees

Headquarters location

Nutley, NJ, US

Year founded

1995

Social media

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