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Iso 14971 Jobs (NOW HIRING)

NAM Info Inc

Senior Medical Device Engineer

Blue Ash, OH · On-site

$96K - $131K/yr

Drive risk management activities using ISO 14971, DFMEA, PFMEA, and hazard analysis. * Partner with suppliers on component qualification, DFM reviews, and manufacturing readiness. * Support process ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... 13485, ISO 14971, and other applicable global regulatory requirements. This role focuses on both process and product quality assurance, driving continuous improvement in product quality, patient ...

Jobtailor

NY · On-site

ISO 14971 * IEC 82304 * Regulatory Standards * Systematic Methodologies #J-18808-Ljbffr

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Iso 14971 information

What is ISO 14971?

ISO 14971 is an international standard that outlines the requirements for risk management in the design and production of medical devices. It provides a systematic process for identifying, evaluating, and controlling risks to ensure the safety of patients, users, and others involved with medical devices. Compliance with ISO 14971 is often required by regulatory bodies and helps manufacturers demonstrate that they have taken appropriate steps to minimize potential hazards associated with their products.

What are the common challenges faced by professionals implementing ISO 14971 in medical device companies?

One of the main challenges in implementing ISO 14971 is ensuring cross-functional collaboration between engineering, quality assurance, regulatory, and clinical teams to comprehensively identify and manage risks throughout the product lifecycle. Professionals often face the task of translating complex technical data into clear risk management documentation that meets regulatory expectations. Keeping up with evolving regulations and maintaining consistent risk management practices across multiple projects can also be demanding. Effective communication and ongoing training are essential to successfully embed ISO 14971 processes into everyday operations.

What are the key skills and qualifications needed to thrive as an ISO 14971 risk management specialist, and why are they important?

To thrive as an ISO 14971 Risk Management Specialist, you need a strong understanding of risk management principles, regulatory standards for medical devices, and a relevant science or engineering background. Experience with risk assessment tools, quality management systems (such as ISO 13485), and familiarity with documentation software are typically required. Excellent analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These capabilities are critical to ensuring compliance, patient safety, and the successful commercialization of medical devices.

What is the difference between Iso 14971 vs Medical Device Quality Engineer?

AspectIso 14971Medical Device Quality Engineer
CertificationsISO 14971 certification, risk management trainingISO 13485, Six Sigma, quality management certifications
Work EnvironmentRegulatory compliance, risk assessment in medical device developmentQuality assurance, process improvement, audits in medical device manufacturing
Industry UsageUsed by regulatory professionals and risk managersUsed by quality assurance and engineering teams

While Iso 14971 focuses on risk management standards for medical devices, a Medical Device Quality Engineer ensures overall product quality and compliance. Both roles are essential in the medical device industry but serve different functions—one emphasizes risk assessment, the other quality assurance.

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Infographic showing various Iso 14971 job openings in the United States as of September 2026, with employment types broken down into 92% Full Time, 2% Part Time, 4% Contract, and 2% Nights. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution.

Senior Software Design Quality Engineer

Marlborough, MA • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

182nd of 499 rated machine equipment manufacturers

Job description


Position Summary
The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives integration of ISO 14971 risk management into the software development lifecycle (SDLC), and ensures alignment to IEC 62304 and applicable Software as a Medical Device (SaMD) expectations. Post-market signals are leveraged as structured inputs to design improvements. Ensures traceability and alignment across design inputs, verification, and validation to meet regulatory expectations under all applicable design and development regulations and standards.
Foundations of Success
  1. Lead with Ownership: Demonstrate accountability and integrity in all actions.
  2. Act with Speed: Drive timely, effective solutions and keep stakeholders informed.
  3. Foster Partnerships: Build strong, collaborative relationships across functions.
  4. Delight Customers: Champion innovative, customer-centric improvements.
  5. Celebrate Wins: Inspire and recognize impactful results and team achievements.

Essential Duties and Responsibilities
The incumbent may be required to perform additional duties related to the functions listed below:
Software Design Quality Ownership
  • Serves as Design Quality representative on software NPD core teams.
  • Owns design quality strategy for new and modified software-enabled products.
  • Ensures design inputs are complete, testable, and aligned to intended use.
  • Ensures design outputs are appropriately translated into production specifications.
  • Approves software design quality deliverables, including design inputs, risk analyses, V&V strategy, and design reviews.

Risk Management Integration
  • Owns software-related risk management activities per ISO 14971.
  • Ensures traceable linkage between hazards, design requirements, and verification evidence.
  • Maintains risk files with production and post-production feedback per ISO 14971 Section 10.

Verification and Validation Strategy
  • Approves risk-based V&V approaches for software systems.
  • Ensures validation reflects real-world use conditions and user needs.
  • Confirms V&V coverage is traceable to requirements and identified hazards.
  • Determines adequacy of verification and validation evidence relative to intended use and risk.

Software and System Behavior
  • Leads analysis of software-related failure modes, with focus on real-world use conditions and system interactions.
  • Drives design improvements to strengthen system robustness, error handling, and user-visible behavior.
  • Ensures software and system behavior are sufficiently defined and diagnosable to support effective investigation of field issues.

Post-Market Signal Integration
  • Reviews software-related complaint trends and field signals as inputs to design.
  • Translates signals into design improvements, risk file updates, or verification gap closure.
  • Engages in complaint investigations where software or system behavior indicates potential design or risk control gaps.

Cross-Functional Leadership
  • Drives alignment across R&D, Systems, Regulatory, and Service.
  • Influences product decisions to improve quality, reliability, and compliance.
  • Mentors junior engineers on software design quality practices.
  • Serves as the quality authority in design reviews, providing independent oversight per ISO 13485 design control expectations.

Requirements / Qualifications
Qualifications will be assessed holistically, and equivalent education, experience, and demonstrated skills may fulfill these requirements.
  • Bachelor's degree in computer science, software engineering, or related technical discipline; advanced degree preferred.
  • 8+ years of experience in quality, software, or systems engineering within the medical device or comparable regulated industry.
  • Demonstrated experience in software NPD / design assurance activities in regulated medical devices, including design controls and risk management.
  • Deep working knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.
  • Proven experience translating field issues into design changes and closed-loop risk updates.
  • Experience with SaMD and QI/ML-enabled medical devices preferred; familiarly with FDA guidance on AI/ML and the EU Act is a plus.
  • Strong technical leadership, cross-functional influence, and written communication skills.
  • Experience with software system architecture, interfaces, and failure modes in complex electromechanical systems.
  • Preferred certifications: ASQ CQE or CSQE, or a comparable quality or reliability certification.

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
#LI-AV1
Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

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