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Medical Device Risk Management Jobs in Rahway, NJ

American Express

Directors, Risk Management

Manhattan, NY · On-site

$195K - $215K/yr

American Express Company seeks Directors, Risk Management to drive credit line underwriting, as ... medical, dental, vision, life insurance, and disability benefits • 20+ weeks paid parental leave ...

New

American Express

Dir-Risk Management

New York, NY · On-site

Comprehensive medical, dental, vision, life insurance, and disability benefits * Flexible working ... Partner with Control Management and other stakeholders to support broader risk, governance, and ...

Getinge

Medical Affairs Manager - NJ

Wayne, NJ

The Medical Affairs Manager is responsible for providing pertinent literature, education, and ... device or devices, in accordance with both internal risk management processes and applicable ...

Getinge

Medical Affairs Manager - NJ

Wayne, NJ · On-site

The Medical Affairs Manager is responsible for providing pertinent literature, education, and ... device or devices, in accordance with both internal risk management processes and applicable ...

American Express

Dir-Risk Management

New York, NY

Comprehensive medical, dental, vision, life insurance, and disability benefits * Flexible working ... Knowledge of risk management frameworks, regulatory landscape, and methodologies. Preferred ...

Jefferies

AVP, Liquidity Risk Management

Manhattan, NY

$150K - $175K/yr

Team The Global Risk Management team is based across the New York, London, Frankfurt, and Asia ... medical condition, physical or mental disability, marital status, domestic partner status, sex ...

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Showing results 41-60

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Rahway, NJ

Medical Device Risk Management information

See Rahway, NJ salary details

$52.3K

$113.3K

$172.6K

How much do medical device risk management jobs pay per year?

As of Aug 8, 2026, the average yearly pay for medical device risk management in Rahway, NJ is $113,255.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,400.00 and $131,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.
What cities near Rahway, NJ are hiring for Medical Device Risk Management jobs? Cities near Rahway, NJ with the most Medical Device Risk Management job openings:
Medical Device Risk Management jobs near you

Design Software Quality Consultant (Medical Devices)

Stark Pharma Solutions Inc

Piscataway, NJ • Remote

Contractor

Re-posted 8 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Design Software Quality position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Design Software Quality Consultant (Medical Devices)

Location: REMOTE
Duration: Long Term
 

Position Overview

We are seeking an experienced Design Software Quality Consultant to support post-acquisition integration activities for a medical device product portfolio. This role will focus on ensuring software design quality, regulatory compliance, and successful integration of acquired products into the client's quality management system.

The ideal candidate will have deep expertise in Software Design Quality, Model-Based Systems Engineering (MBSE), and medical device software compliance, with experience supporting new product development in regulated environments.

Key Responsibilities

  • Review and assess Design History Files (DHFs) and product development documentation for acquired medical device products.
  • Support software design quality activities during post-acquisition product integration.
  • Ensure compliance with internal quality standards and global regulatory requirements.
  • Lead Model-Based Systems Engineering (MBSE) activities for software-enabled medical devices.
  • Review software engineering deliverables to ensure compliance with design controls and quality requirements.
  • Partner with cross-functional teams including R&D, Software Engineering, Quality, and Regulatory Affairs.
  • Support risk management, usability engineering, and software lifecycle compliance activities.

Required Qualifications

  • 10+ years of Software Quality Engineering experience in the medical device industry.
  • Strong experience with Software Design Quality and Design Controls.
  • Hands-on experience with Model-Based Systems Engineering (MBSE).
  • Experience supporting software quality for new product development or medical device integration/remediation projects.
  • Knowledge of IEC 62304, IEC 60601, ISO 14971, and medical device software regulations.
  • Experience with Software as a Medical Device (SaMD).
  • Strong understanding of software verification, validation, and compliance within regulated environments.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com