Design Quality Engineer - Medical Devices (ISO 13485)
Dormont Manufacturing Co
Dormont Manufacturing Co in Austin, Texas, is seeking a Quality Assurance Engineer responsible for implementing quality assurance procedures for New Product Development and sustaining projects. This role demands strong expertise in engineering principles and compliance with industry standards including ISO and FDA. The ideal candidate holds a Bachelor’s in Biomedical or Mechanical Engineering with at least 3 years of experience in a regulated industry such as medical devices. Key skills include knowledge of technical writing, quality assurance, and manufacturing processes. A supportive work environment fosters continuous improvement and growth. #J-18808-Ljbffr Dormont Manufacturing Co
$100k - $125k
...Senseye is developing AI-enabled software medical devices to help make mental health... ...starting with PTSD. We are looking for a Design Quality Engineer for our software medical device (... ...documentation. ~ Working knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QMSR / 2...SuggestedTemporary workFlexible hours$112.42k - $154.57k
...and external safety, quality and regulatory standards... ...system changes with Engineering and Manufacturing.... ...engineering support for designing and conducting... ...related experience in the medical device industry. Proven experience... ..., such as 21CFR820, ISO 13485:2016, EU MDR....SuggestedTemporary workWork at officeLocal area- Creative Solutions Services, LLC is seeking a Quality Systems Engineer III in Austin, TX. This hybrid role requires 5+ years of experience in Quality/Regulatory Compliance, ensuring adherence to medical device regulations. You will support the implementation of the Quality...Suggested
- Dormont Manufacturing Co in Austin, Texas, is looking for an experienced engineer to ensure compliance with safety and quality standards in the medical device industry. Responsibilities include providing engineering support for production processes, leading data analysis...Suggested
- Enovis Corp is seeking an RA/QA Engineer in Austin, Texas. This full-time role involves maintaining quality assurance procedures, supporting New Product Development, and ensuring compliance with ISO and FDA regulations. Candidates should possess a Bachelor's degree in...SuggestedFull timeWork at office
- Abbott is seeking an Engineer II in Austin, TX to support Quality Operations within the medical device manufacturing sector. The ideal candidate will possess a Bachelor's degree in Engineering and at least 3 years of relevant experience. Responsibilities include overseeing...
- RA/QA Engineer page is loaded## RA/QA Engineerlocations... ...innovation-driven medical technology growth... ...regarding the design, implementation, and maintenance of quality assurance procedures... ...design quality in ISO and FDA audits* Authoring... ...trends in device failures associated...Work at office
- Quality Systems Engineer III Austin, TX Hybrid - 3 days in office, 2 remote 6... ...compliance with applicable medical device regulations and standards,... ...FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, and corporate... ...as purchasing controls, design controls, nonconformance...Contract workWork at officeLocal areaRemote work
- Quality Systems Engineer III Austin, TX Hybrid - 3 days in office, 2 remote... ...compliance with applicable medical device regulations and standards,... ...FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as... ...limited to purchasing controls, design controls, nonconformance...Contract workWork at officeLocal areaRemote work
- ACE Partners, a leading cardiac device manufacturer in Austin, Texas, is seeking a Process Engineer III to own precision machining processes and troubleshoot CNC equipment. The ideal candidate will have a strong background in high-precision manufacturing, particularly in...
- A leading medical devices company based in Austin, Texas, is seeking a Process Engineer to provide engineering support for manufacturing processes. The role involves improving efficiency, ensuring adherence to operating procedures, and collaborating on new product launches...
- ...Senior Product Development Engineer to be an integral member of... ...R&D Team. The role involves design and development of surgical... ...development, as well as experience in medical device innovation. Responsibilities... ...teams to ensure product quality and compliance with all...
- A leading medical technology company in Austin, TX is seeking... ...Product Development Engineer to participate in the design and development of surgical... ...experience in the medical device industry is preferred. The... ...across teams to ensure high-quality outcomes. #J-18808-Ljbffr...
- ...Austin, Texas, is searching for a Process Engineer responsible for providing engineering... .... This role involves collaborating with quality and operations teams, ensuring adherence... ...comprehensive benefits package, including medical, dental, and a 401(k) plan. #J-18808-...
- Zimmer Biomet in Austin, Texas is seeking an experienced Engineer to drive product functional requirements and testing strategies in the medical device sector. Your role will involve designing and integrating components, identifying issues, and meeting performance targets...
$100k
Senior Manufacturing Engineer - Printed Circuit Heat Exchangers About... ...-fabricated microreactors designed to deliver affordable, scalable... ...and throughput Partner with Quality and NDE teams to develop... ...environments (e.g., NQA‑1, AS9100, ISO 13485, ISO 9001) Direct...Permanent employment- Zimmer GmbH is seeking a Senior Mechanical Engineer for Monogram in Austin, Texas. The role... ...include defining requirements, designing components, and collaborating with cross... ...s degree in Engineering, experience in medical devices, and proficiency in tools like Solidworks...
- Abbott Laboratories is seeking a Senior Technical Engineer for our Austin, TX location in the Diabetes Care division. The role focuses on advancing glucose monitoring technologies and involves significant responsibilities such as providing technical support, project management...
- A medical technology company in Austin, Texas is looking for a Process Engineering Manager to lead a team for new product introduction. This role involves designing new manufacturing processes, implementing improvements... ..., preferably in medical device manufacturing. This...
- ...Austin, Texas is looking for a Manager, Process Engineering to lead a team focused on new product introduction in medical technology. This role involves overseeing... ...innovations and improvements while ensuring efficient design transfer into production. Successful candidates...
- ...Job Description Quality Specialist, Entry Level... ...within an FDA-regulated, ISO 13485 environment... ..., Manufacturing, and Engineering teams, the Quality Inspector... ...and relevant global medical device standards. Review,... ...quality documentation, design controls, validation,...Contract workTemporary workLocal areaWorldwide
- ...in Austin, Texas is seeking an embedded software engineer to work closely with neuroengineers and electronic designers. The role involves developing firmware for brain... ...offers a chance to contribute to innovative medical technology with a focus on performance and document...
- ...System and Software Testing for Medical Device (Electrosurgical) Location:... ...with standards (e.g., IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820). Lead the design and maintenance of automation frameworks... ...code analysis to maintain code quality, reduce technical debt, and...
- ...to join our team. We are looking to add a Senior Wire Harness Design Engineer I to our team. If you enjoy working in a startup environment... ...regulations related to wire harness design, such as IPC‑WHMA‑A‑620 and ISO 9001. Extensive hands‑on experience with lab instruments such...Permanent employmentFull timeContract workWork experience placementLocal area
- ...Title: Principal Mechanical Integration Engineer Job Family : Mechanical Design Engineering Organization : Data... ...compliance with applicable standards (ASME, ISO). Establish and oversee validation... ...electrical, thermal, manufacturing, quality, and supply chain teams to ensure...Remote work
- ...join our team. We are looking to add a Senior Wire Harness Design Engineer I to our team. If you enjoy working in a startup environment... ...related to wire harness design, such as IPC-WHMA-A-620 and ISO 9001. ~ Extensive hands-on experience with lab instruments such...Permanent employmentFull timeContract workWork experience placementLocal area
- ...experienced Staff Electrical Safety Engineer to drive our electrical safety... ...in robotics, automotive, medical, personal electronics, or... ...the strategy for requirements, design, and testing for the electrical... ...compliance including one or more ISO 13849-1, IEC 61508, IEC 60204-...Contract workLocal area
- Biorce is seeking a Quality and Regulatory Affairs Manager in Austin to oversee the regulatory frameworks for... .... This role requires 5+ years of experience in medical device quality assurance and expertise in ISO 13485 and IEC 62304. Join a dynamic Healthtech environment...Work at office
- ...Job Overview : The Supplier Quality Engineer is responsible for ensuring... ...materials. Ensure that product design, specifications, and... ...company quality standards (ISO, TS16949, etc.). Continuous... ...automotive, defense, aerospace, medical devices, etc.). Physical Demands Prolonged...Permanent employmentTemporary workWork experience placementWork at office
- ...hiring a Senior/Staff Product Certification Engineer to own product compliance and safety... ...strategies for new product introductions and design iterations across the portfolio. Run the... ...entry. Functional Safety background (ISO 26262 or IEC 61508). Familiarity with European...RelocationRelocation package
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