ISO 13485 Jobs

41 - 60 of 144 Jobs

Quality Assurance Engineer (Medical Device)Job Title - Quality Assurance Engineer (Medical Device)

Judge Group, Inc.Company Name - Judge Group, Inc.

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Framingham, Massachusetts, USA

Contract

Location: Framingham, MA Salary: $90,000.00 USD Annually - $105,000.00 USD Annually Description: Our client is currently seeking a Quality Assurance Engineer (Medical Device). This is a permanent, direct hire, on site role. Key Responsibilities: Investigate material nonconformance issues and resolve supplier concerns. Maintain calibration system and ensure compliance with 21 CFR 820 & ISO 13485. Support manufacturing engineering with documentation and process improvements. Assist in prod

Need - Computer Software Validation (CSV) EngineerJob Title - Need - Computer Software Validation (CSV) Engineer

ASCII Group LLCCompany Name - ASCII Group LLC

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Santa Clara, California, USA

Contract, Third Party

Hi, The following requirement is open with our client. Title : Computer Software Validation (CSV) Engineer Location : Santa Clara, CA (ONSITE) Duration : 12+ Months Relevant Experience (in Yrs.) : 8+ Job Description: Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 c, ISO 13485, IEC 62304).Experience with non-product software v

Product Manager Front-End ApplicationsJob Title - Product Manager Front-End Applications

Headway Tek IncCompany Name - Headway Tek Inc

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Alameda, California, USA

Full-time, Part-time, Contract, Third Party

Role: Product Manager Front-End Applications (Life Sciences) Years of Experience: 8+ years Location: Onsite, Alameda, CA (Hybrid 2-3 days) As a consultant within the Vertical team, you will work with our clients to define their digital strategy and execution roadmap, and design and implement differentiated digital solutions to help deliver measurable value. Job Description: We are seeking a highly motivated Product Manager to lead the strategy, development, and optimization of front-end applic

Regulatory Affairs Specialist- 100% remote in FLJob Title - Regulatory Affairs Specialist- 100% remote in FL

ConsultNet, LLCCompany Name - ConsultNet, LLC

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Remote or Florida, USA

Full-time

Regulatory Affairs Specialist 100% Remote from anywhere in Florida 6+ month contract to hire $38.50- $52.00 an hour ($80k- $110k salary upon conversion) Immediate hire with growing company. The Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presente

Product Owner/Manager- MedicalJob Title - Product Owner/Manager- Medical

INSPYR SolutionsCompany Name - INSPYR Solutions

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Remote or Santa Clara, California, USA

Contract

About the Role We are seeking an experienced and driven Product Owner/Manager with a strong background in medical hardware product development . This role is critical in bridging the gap between clinical needs, engineering, regulatory requirements, and market demands to ensure delivery of high-impact, safe, and effective medical devices. The ideal candidate will possess a deep understanding of the medical hardware lifecycle, from concept through commercialization, including regulatory pathways (

Director, Device EngineeringJob Title - Director, Device Engineering

Gilead Sciences, Inc.Company Name - Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

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

Verification Test Equipment EngineerJob Title - Verification Test Equipment Engineer

Philips North AmericaCompany Name - Philips North America

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Bothell, Washington, USA

Full-time

Job Title Verification Test Equipment Engineer Job Description Verification Test Equipment Engineer (Bothell, WA) This is an exciting opportunity to join the Oral Healthcare team as a Verification Test Equipment Engineer, contributing to the development of next-generation Sonicare products. In this fast-paced role, you will support Systems Engineering and the Test & Verification Lab by ensuring that product testing equipment is designed, maintained, and optimized to effectively verify that pr

Validation EngineerJob Title - Validation Engineer

FlextronicsCompany Name - Flextronics

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Libertyville, Illinois, USA

Full-time

Job Posting Start Date 07-15-2025 Job Posting End Date 09-15-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord

Senior Engineer, R&D ComplianceJob Title - Senior Engineer, R&D Compliance

ICU Medical, Inc.Company Name - ICU Medical, Inc.

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Remote

Full-time

Job Description Position Summary This position is responsible for leading regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with global medical device standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, and ISO 14971. Essential Duties & Responsibilities Material Compliance & Restricted Substances: Lead and manage EU MDR-related DHF remediation activities with a focus on legacy material compliance and regulatory gap assessments. Au

Mechanical Engineer IIJob Title - Mechanical Engineer II

Fresenius Medical CareCompany Name - Fresenius Medical Care

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Remote or Lawrence, Massachusetts, USA

Full-time

PURPOSE AND SCOPE: The Mechanical Engineer II will play a key role in improving our Home HD products and our patients' lives. This individual will apply sound engineering principles in the support of our current product portfolio and will be involved in different parts of a product's life, including but not limited to the feasibility evaluation for new features and products to improve the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for suppo

Sr CAPA EngineerJob Title - Sr CAPA Engineer

Fresenius Medical CareCompany Name - Fresenius Medical Care

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Remote or Waltham, Massachusetts, USA

Full-time

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form ADDENDUM: GMS CAPA Office Focus Responsible for development of an appropriate strategy to implement all necessary requirements from FME Quality Management and formerly used NC/CAPA tools into one global electronic NC/CAPA tool. Assists global NC/CAPA process owner with process definition, documentation, implementation, and maintenance.

Engineer II, QualityJob Title - Engineer II, Quality

Masimo CorporationCompany Name - Masimo Corporation

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Irvine, California, USA

Full-time

Job Description Job Summary The Quality Engineer position at Masimo is a multifaceted role that requires a wide breadth of engineering knowledge. An individual in this role will work as part of the Product Assurance department to help drive quality in the company's growing product portfolio. As an integral part of the product development team, quality engineers help guide and direct the team to produce quality products. As a result, a person in this position should be comfortable in all facets

Principal R&D Engineer - ElectrophysiologyJob Title - Principal R&D Engineer - Electrophysiology

Boston Scientific CorporationCompany Name - Boston Scientific Corporation

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Arden Hills, Minnesota, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your

Staff EngineerJob Title - Staff Engineer

Becton Dickinson & CompanyCompany Name - Becton Dickinson & Company

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Brea, California, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human e

Senior R&D Engineer - ElectrophysiologyJob Title - Senior R&D Engineer - Electrophysiology

Boston Scientific CorporationCompany Name - Boston Scientific Corporation

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Arden Hills, Minnesota, USA

Full-time

Hiring Manager: Jenna Marie Rubbelke Recruiter: Jujhar Singh Bains About the role: The Ablation Catheter Development Team is growing and has an exciting opportunity for a senior engineer role supporting electrophysiology product development within the Cardiology division. Electrophysiology is an exciting growth driver for BSC. With the acquisition of FARAPULSE Inc., Boston Scientific will strengthen its leadership in Personalized EP Solutions, with a strong focus in Atrial Fibrillation. The se

Sr. Systems Engineer, R&D - BD Advanced Patient MonitoringJob Title - Sr. Systems Engineer, R&D - BD Advanced Patient Monitoring

Becton Dickinson & CompanyCompany Name - Becton Dickinson & Company

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Irvine, California, USA

Full-time

Principal Laser Test EngineerJob Title - Principal Laser Test Engineer

Boston Scientific CorporationCompany Name - Boston Scientific Corporation

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Carlsbad, California, USA

Full-time

Device EngineerJob Title - Device Engineer

Amgen IncCompany Name - Amgen Inc

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Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea

Advisor / Sr. Advisor in Computer-Aided Engineering (DDCS)Job Title - Advisor / Sr. Advisor in Computer-Aided Engineering (DDCS)

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Senior Manager Systems EngineeringJob Title - Senior Manager Systems Engineering

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Cincinnati, Ohio, USA

Full-time

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