The Medical Device Complaint Trending Expert is responsible for the end-to-end development ... The individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, ...
The Medical Device Complaint Trending Expert is responsible for the end-to-end development ... The individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, ...
Quality Engineer / Sustaining Design Quality / Medical Devices
Salt Lake City, UT · On-site
$55 - $68/hr
The role focuses on Design Controls, Risk Management, and regulatory compliance throughout the product lifecycle. Required Skills: * Medical Device or regulated industry experience * Design Controls ...
Quick apply
Quality Engineer / Sustaining Design Quality / Medical Devices
Salt Lake City, UT · On-site
$55 - $68/hr
The role focuses on Design Controls, Risk Management, and regulatory compliance throughout the product lifecycle. Required Skills: * Medical Device or regulated industry experience * Design Controls ...
Device and behavioral intelligence * Account linking and bank verification tools * ACH risk and ... Company 401k contribution of 5%. * Healthcare coverage contribution, including medical, dental and ...
Device and behavioral intelligence * Account linking and bank verification tools * ACH risk and ... Company 401k contribution of 5%. * Healthcare coverage contribution, including medical, dental and ...
... medical device environment. This role focuses on developing and maintaining Design History File (DHF) documentation, defining system and product requirements, supporting risk management and ...
Quick apply
... medical device environment. This role focuses on developing and maintaining Design History File (DHF) documentation, defining system and product requirements, supporting risk management and ...
Quality Engineer
West Valley City, UT · On-site
$69K - $89K/yr
... medical device environment. The ideal candidate will possess strong technical expertise in traceability matrix verification (TMV), risk management, verification and validation (V&V), and design ...
Quick apply
Quality Engineer
West Valley City, UT · On-site
$69K - $89K/yr
... medical device environment. The ideal candidate will possess strong technical expertise in traceability matrix verification (TMV), risk management, verification and validation (V&V), and design ...
Quality Engineer 3
Salt Lake City, UT · On-site
$60 - $65/hr
... Management • Risk Management activities Nice To Have • Disposable medical device experience Job Summary: This position is accountable for supporting new product development and product ...
Quick apply
Quality Engineer 3
Salt Lake City, UT · On-site
$60 - $65/hr
... Management • Risk Management activities Nice To Have • Disposable medical device experience Job Summary: This position is accountable for supporting new product development and product ...
Engr 3, Quality
Salt Lake City, UT · On-site
$69K - $89K/yr
... Risk Management activities'] Start: ['Disposable medical device experience'] At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of ...
Engr 3, Quality
Salt Lake City, UT · On-site
$69K - $89K/yr
... Risk Management activities'] Start: ['Disposable medical device experience'] At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of ...
Senior Engineer, R&D
Salt Lake City, UT · On-site
$101K - $138K/yr
The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management. Essential Duties ...
Senior Engineer, R&D
Salt Lake City, UT · On-site
$101K - $138K/yr
The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management. Essential Duties ...
Senior Engineer, R&D
$101K - $138K/yr
The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management. Essential Duties ...
Senior Engineer, R&D
$101K - $138K/yr
The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management. Essential Duties ...
Staff Engineer, Quality Design & Reliability Assurance
West Valley City, UT · On-site
$109K - $149K/yr
... Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. Strong analytical skills and a working knowledge of ...
Staff Engineer, Quality Design & Reliability Assurance
West Valley City, UT · On-site
$109K - $149K/yr
... Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. Strong analytical skills and a working knowledge of ...
Medical, Dental & Vision coverage * 401k * Educational Assistance * Life Insurance * Employee ... Risk Management Analyst: 2 Years experience with Bachelors; 0 Years with Masters; an additional 4 ...
Medical, Dental & Vision coverage * 401k * Educational Assistance * Life Insurance * Employee ... Risk Management Analyst: 2 Years experience with Bachelors; 0 Years with Masters; an additional 4 ...
Sentinel Risk Management Analyst/Principal Risk Management Analyst - 18681*
Roy, UT · On-site
$81K - $122K/yr
Medical, Dental & Vision coverage * 401k * Educational Assistance * Life Insurance * Employee ... Risk Management Analyst: 2 Years experience with Bachelors; 0 Years with Masters; an additional 4 ...
Sentinel Risk Management Analyst/Principal Risk Management Analyst - 18681*
Roy, UT · On-site
$81K - $122K/yr
Medical, Dental & Vision coverage * 401k * Educational Assistance * Life Insurance * Employee ... Risk Management Analyst: 2 Years experience with Bachelors; 0 Years with Masters; an additional 4 ...
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal ... Device Master Record creation. • Responsible for coordinating process risk analysis/management ...
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal ... Device Master Record creation. • Responsible for coordinating process risk analysis/management ...
Model Risk Management Analyst
Ogden, UT · On-site
We are looking for a Model Risk Management Analyst to join our BI/Data Analytics team at TAB Bank ... Medical, Dental, Vision, Life and AD&D, Voluntary Disability, Flex Spending & Dependent Care TAB ...
Model Risk Management Analyst
Ogden, UT · On-site
We are looking for a Model Risk Management Analyst to join our BI/Data Analytics team at TAB Bank ... Medical, Dental, Vision, Life and AD&D, Voluntary Disability, Flex Spending & Dependent Care TAB ...
We are looking for a Model Risk Management Analyst to join our BI/Data Analytics team at TAB Bank ... Medical, Dental, Vision, Life and AD&D, Voluntary Disability, Flex Spending & Dependent Care TAB ...
We are looking for a Model Risk Management Analyst to join our BI/Data Analytics team at TAB Bank ... Medical, Dental, Vision, Life and AD&D, Voluntary Disability, Flex Spending & Dependent Care TAB ...
Quality Engineer
West Valley City, UT · On-site
$69K - $89K/yr
... medical device environment. This role requires strong technical expertise in Design Controls, Risk Management, Verification & Validation (V&V), and Technical Risk Management (TRM/TMV) , with the ...
Quick apply
Quality Engineer
West Valley City, UT · On-site
$69K - $89K/yr
... medical device environment. This role requires strong technical expertise in Design Controls, Risk Management, Verification & Validation (V&V), and Technical Risk Management (TRM/TMV) , with the ...
Medical Device Sales | Healthcare Sales | B2B Sales | Pharmaceutical Sales Location: Salt Lake City ... Account Management * Clinical Sales * Inside Sales with outside customer interaction * Excellent ...
Quick apply
Medical Device Sales | Healthcare Sales | B2B Sales | Pharmaceutical Sales Location: Salt Lake City ... Account Management * Clinical Sales * Inside Sales with outside customer interaction * Excellent ...
Medical Device Sales | Healthcare Sales | B2B Sales | Pharmaceutical Sales Location: Salt Lake City ... Account Management * Clinical Sales * Inside Sales with outside customer interaction * Excellent ...
Medical Device Sales | Healthcare Sales | B2B Sales | Pharmaceutical Sales Location: Salt Lake City ... Account Management * Clinical Sales * Inside Sales with outside customer interaction * Excellent ...
... Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. Strong analytical skills and a working knowledge of ...
... Risk Management (ISO 14971 2019), EU MDR, MDD (Medical Device Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP. Strong analytical skills and a working knowledge of ...
... and Device Master Record creation. • Responsible for coordinating risk analysis/management ... Medical device experience or equivalent experience in a regulated industry. * Experience with ...
... and Device Master Record creation. • Responsible for coordinating risk analysis/management ... Medical device experience or equivalent experience in a regulated industry. * Experience with ...
Medical Device Risk Management information
See Utah salary details
$46.9K - $56.7K
4% of jobs
$56.7K - $66.5K
6% of jobs
$66.5K - $76.3K
11% of jobs
$80K is the 25th percentile. Wages below this are outliers.
$76.3K - $86.1K
11% of jobs
The median wage is $93.9K / yr.
$86.1K - $95.9K
23% of jobs
$95.9K - $105.7K
13% of jobs
$112.2K is the 75th percentile. Wages above this are outliers.
$105.7K - $115.5K
12% of jobs
$115.5K - $125.3K
8% of jobs
$125.3K - $135.1K
6% of jobs
$135.1K - $145K
4% of jobs
$145K - $154.8K
2% of jobs
$46.9K
$101.6K
$154.8K
How much do medical device risk management jobs pay per year?
Is risk management a good career?
What is the highest paying risk management job?
How much does a risk manager get paid?
What are the key skills and qualifications needed to thrive in Medical Device Risk Management, and why are they important?
What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?
| Aspect | Medical Device Risk Management | Medical Device Quality Assurance |
|---|---|---|
| Primary Focus | Identifying, evaluating, and mitigating risks associated with medical devices | Ensuring products meet quality standards and regulatory requirements |
| Certifications | ISO 14971, RAPS certifications often preferred | ISO 13485, regulatory compliance certifications |
| Work Environment | Design and development teams, risk analysis meetings | Manufacturing, inspection, and quality control departments |
| Industry Usage | Used throughout product lifecycle for safety management | Used 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 risk management in the medical device industry?
What is medical device risk management?
How does a Medical Device Risk Management professional typically collaborate with cross-functional teams during the product development lifecycle?
$81K - $112K/yr
Full-time
Medical, Dental, Vision, Life, Retirement
Posted 27 days ago
Integra LifeSciences rating
9.4
Based on 9 frontline employees who took The Breakroom Quiz
Job description
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Medical Device Complaint Trending Expert is responsible for the end-to-end development, execution, and oversight of complaint data trending and signal detection activities to ensure timely identification of product quality, safety, and compliance risks. This role serves as a subject matter expert (SME) for complaint analytics, statistical trending methodologies, and regulatory expectations related to post-market surveillance.
The individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, Manufacturing, and Medical Safety to translate complex complaint data into actionable insights that support corrective and preventive actions (CAPA), regulatory submissions, and risk management decisions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Work end to end complaint trending data and analysis
- Identify trends within complaints being able to know the difference between variation vs signal.
- Design, maintain, and continuously improve complaint trending methodologies aligned with regulatory and business risk principles
- Perform routine and ad hoc trending analyses to identify statistically significant signals, emerging risks, and adverse trends
- Apply appropriate statistical tools and data visualization techniques to evaluate complaint data across products, failure modes, and geographies
- Establish alert thresholds, escalation criteria, and signal validation processes
- Support inspections, and audits with defensible trending analyses and documentation
- Author or review SOPs, work instructions, and templates related to trending and post-market surveillance
- Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions
- Collaborate with Medical Safety, Clinical, and Regulatory teams to evaluate patient safety and reporting impact
- Present trending results and risk assessments to management, governance boards, and quality review councils
- Serve as SME for complaint data systems and analytics tools (e.g., validated QMS systems, dashboards, and reporting platforms)
- Ensure data integrity, consistency, and traceability across complaint datasets
- Develop standardized dashboards, trend reports, and executive summaries
- Interpret and analyze complex data sets and clearly communicate findings to both technical and non-technical stakeholders
- Monitor industry best practices and regulatory guidance related to complaint trending and post-market surveillance
- Identify process improvements to enhance early signal detection, efficiency, and compliance
- Mentor and train colleagues on trending methodologies and regulatory rationale
- Bachelor's degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or a related field
- Minimum 5-8 years of experience in medical device quality, complaint handling, post-market surveillance, or safety analytics
- Demonstrated expertise in complaint trending, signal detection, and root cause analysis
- Strong knowledge of global medical device regulations (FDA, EU MDR, ISO standards)
- Advanced analytical and problem-solving skills with the ability to interpret complex data
- Excellent written and verbal communication skills
- Strong knowledge of global medical device regulations
- 21 CFR Parts 803 and 820 / QSR and QMSR
- EU MDR (Articles 83-86)
- MDSAP and ISO 13485
- ISO 13485 and 14971
- Experience presenting to internal leadership as well as regulators/auditors.
Preferred Qualifications
- Advanced degree (MS, MBA, or equivalent).
- Proficiency with statistical software or data visualization tools (e.g., Minitab, Power BI, Oracle, TrackWise)
- Experience working with global complaint databases and high-volume product portfolios
Additional Qualifications
- Strong oral and written English communication skills and effective interpersonal skills.
- Experience in FDA-regulated environment.
- Strong collaboration skills and experience working in a matrix environment.
- Ability to multitask, prioritize and meet deadlines.
- Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.
Salary Pay Range:
$81,650.00 - $112,700.00 USD SalaryOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
Integra - Employer Branding from Integra LifeSciences on Vimeo
What Integra LifeSciences employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About Integra LifeSciences
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Princeton, NJ, US
Year founded
1989