ISO 13485 jobs in Broadview Heights, OH

Broadview Heights, Ohio

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Today

Summary : Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards. Roles & Responsibilities : Prepare test samples and fixtures for mechanical and functional testing. Execute tests and document results per Good Documentation Practices (GDP).Generate Test Reports for inclusion in the Design History File (DHF). Coordinate with cross-functional teams to ensure timely completion of testing activities. Education & Experience : Hands-on

Full-time

Development Mechanical Engineer

Broadview Heights, Ohio

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Today

Summary Proficiency in CAD (SolidWorksPTC Creo), GDT, tolerance analysis, and fixture design. Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR). Competence in risk management tools (DFMEA, pFMEA) and traceability from

Full-time

R&D /Product Development Engineer

Cleveland, Ohio

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Today

Roles & Responsibilities: Proficiency in CAD (SolidWorks/Creo). GD&T tolerance analysts, and fixture design. Knowledge of orthopedic testing standards (ASTM F382 F543, F1717. F2/14243, etc.). Strong capability in test protocol/report writing statistical analysis (95/95, tolerance intervals), and data integrity practices. Familiarity with materials and processes: Ti alloys. Coctainless steel UHMWPE, PEEK. AM. coatings. Understanding of design controls ISO 13485, ISO 14971, and regulatory pat

Full-time

Product Development Engineer - Medical Device

Broadview Heights, Ohio

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Today

Summary : Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design. Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO , etc.). Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices. Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (5

Full-time

Senior QMS Process Engineer

Remote or New Jersey

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Today

Responsibilities: Draft, update, and optimize QMS procedures to align with Code beamer upgrades, organizational standards, and regulatory requirements. Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations. Translate technical and regulatory requirements into clear, practical documentation for end users. Support change management processes, ensuring procedural updates are properly controlled and communicated. En

Full-time

Sr. Software Engineer

Remote or Salt Lake City, Utah

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Today

Sr. Software Engineer (onsite or remote depending on location) Salt Lake City, UT or Denver, CO Direct Hire Pay: $140k-$160k Job Description: Our client is looking for a Sr. Software Engineer. As part of the team working in R&D, you will work across multiple languages and frameworks, including React Native, React, TypeScript, JavaScript, Python, and AWS (Flutter is a plus). You'll operate within a regulated SDLC (FDA, 62304/82304) emphasizing automation, testing, observability, cybersecurity,

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Full-time

USD 140,000.00 - 160,000.00 per year

Senior Supplier Engineer

Remote or Danvers, Massachusetts

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 91,000.00 - 147,200.00 per year

Senior IT Purchasing Specialist

Remote

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Today

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing-improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications-from minimally invasive surgery to robotics to 3D metal printing. Novanta is one global

Full-time

USD 72,000.00 - 130,000.00 per year

Clinical Imaging & Machine Learning (ML) Validation Specialist

Remote

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3d ago

Job Title: Clinical Imaging & Machine Learning (ML) Validation Specialist Location: Remote Duration: Long Term Experience: 8 Years Job Summary The Clinical Imaging & ML Validation Specialist is responsible for validating, evaluating, and clinically contextualizing machine learning models applied to medical imaging. This role bridges clinical imaging expertise (radiology, pathology, cardiology, etc.) with data science and regulatory rigor to ensure ML models are accurate, reliable, unbiased, and

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Contract

Depends on Experience

Sr Device Engineer I

Remote or Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 136,340.00 - 176,440.00 per year

Penetration Tester

Remote

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11d ago

Role: Penetration Tester Location: Remote ( Should be travel ready to customer location once in a while for some testing) Job Summary: We are seeking an experienced Penetration Tester with specialized knowledge in medical devices and FDA 510(k) compliance to support our cybersecurity efforts. The ideal candidate will have hands-on experience conducting Threat Modelling, Ethical hacking and vulnerability assessments in FDA-regulated environments, ensuring our connected medical products meet secur

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Contract, Third Party

Depends on Experience

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ISO 13485 jobs in Broadview Heights, OH 44147, USA