Stealth mode (medical device)
Research And Development Engineer
Stealth mode (medical device), Menlo Park, California, United States, 94029
Stealth mode (medical device) provided pay range
This range is provided by Stealth mode (medical device). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$110,000.00/yr - $150,000.00/yr Direct message the job poster from Stealth mode (medical device) Senior Recruiter - Specializes in Biopharma, Med Device, and Biotech
About Us Join an innovative stealth start-up dedicated to transforming the treatment of Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) through a novel catheter-based technology. We’re seeking a motivated and energetic team member to help us bring life-changing solutions to market. If you’re passionate about advancing healthcare in a dynamic and collaborative environment, we would love to hear from you! Overview / Summary We are seeking a highly motivated R&D Engineer – Quality Focus to join our team in advancing innovative medical technologies while ensuring the highest standards of quality and compliance. This position bridges hands-on R&D engineering with rigorous quality oversight. The ideal candidate is equally comfortable conducting experiments, writing detailed reports, and ensuring adherence to regulatory and quality standards. This role is critical in driving R&D deliverables while embedding quality at every stage of product development. Key Responsibilities Documentation & Technical Writing Create and maintain SOPs, test protocols, specifications, and technical reports. Develop and support design control documentation, including design inputs, outputs, traceability, and risk management files. Author verification and validation reports, experimental summaries, and technical justifications. Testing & Validation Support Participate in hands-on testing, method development, and data analysis. Support process and test method validations (IQ, OQ, PQ), ensuring data integrity and regulatory compliance. Assist with preclinical and design verification studies, providing structured documentation of results. Quality Oversight within R&D Apply design control, risk management (ISO 14971), and compliance frameworks (21 CFR Part 820, ISO 13485) to R&D activities. Support internal audits, design reviews, and continuous improvement initiatives to strengthen compliance and design rigor. Partner with Quality and Regulatory Affairs to ensure development deliverables meet FDA, ISO, and industry standards. Cross-Functional Collaboration Work closely with manufacturing, regulatory, and clinical teams to align product design and testing activities with quality and regulatory expectations. Provide guidance on best practices for documentation, traceability, and risk management during R&D phases. Interface with suppliers and internal stakeholders to ensure quality requirements are met across the supply chain. Qualifications & Skills Bachelor’s degree in Biomedical, Mechanical, or related Engineering discipline; advanced degree preferred. 3+ years of experience in R&D engineering, with exposure to quality engineering or medical device product development. Solid understanding of design controls, validation principles, and medical device regulations (21 CFR 820, ISO 13485, ISO 14971). Proven ability to prepare structured technical documentation, protocols, and regulatory-compliant reports. Strong analytical and problem-solving skills, with proficiency in statistical tools (Excel, Minitab, or JMP). Excellent written communication and technical writing skills, with attention to detail. Hands-on lab or testing experience; catheter or capital equipment exposure is a plus. Preferred: ASQ CQE certification or equivalent quality credential. Why Join Us At the intersection of innovation and quality, this role offers the opportunity to shape products that directly improve patient outcomes. You’ll be part of a collaborative team empowered to push technical boundaries while ensuring rigorous quality oversight. We provide an environment where engineering creativity is matched with compliance excellence—ideal for those who thrive on balancing innovation and precision. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering, Science, and Quality Assurance Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Note: This refinement preserves the core job information and removes non-essential postings. It uses only allowed tags, fixes list structure, converts emphasis to bold, and presents content in clear sections.
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This range is provided by Stealth mode (medical device). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$110,000.00/yr - $150,000.00/yr Direct message the job poster from Stealth mode (medical device) Senior Recruiter - Specializes in Biopharma, Med Device, and Biotech
About Us Join an innovative stealth start-up dedicated to transforming the treatment of Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) through a novel catheter-based technology. We’re seeking a motivated and energetic team member to help us bring life-changing solutions to market. If you’re passionate about advancing healthcare in a dynamic and collaborative environment, we would love to hear from you! Overview / Summary We are seeking a highly motivated R&D Engineer – Quality Focus to join our team in advancing innovative medical technologies while ensuring the highest standards of quality and compliance. This position bridges hands-on R&D engineering with rigorous quality oversight. The ideal candidate is equally comfortable conducting experiments, writing detailed reports, and ensuring adherence to regulatory and quality standards. This role is critical in driving R&D deliverables while embedding quality at every stage of product development. Key Responsibilities Documentation & Technical Writing Create and maintain SOPs, test protocols, specifications, and technical reports. Develop and support design control documentation, including design inputs, outputs, traceability, and risk management files. Author verification and validation reports, experimental summaries, and technical justifications. Testing & Validation Support Participate in hands-on testing, method development, and data analysis. Support process and test method validations (IQ, OQ, PQ), ensuring data integrity and regulatory compliance. Assist with preclinical and design verification studies, providing structured documentation of results. Quality Oversight within R&D Apply design control, risk management (ISO 14971), and compliance frameworks (21 CFR Part 820, ISO 13485) to R&D activities. Support internal audits, design reviews, and continuous improvement initiatives to strengthen compliance and design rigor. Partner with Quality and Regulatory Affairs to ensure development deliverables meet FDA, ISO, and industry standards. Cross-Functional Collaboration Work closely with manufacturing, regulatory, and clinical teams to align product design and testing activities with quality and regulatory expectations. Provide guidance on best practices for documentation, traceability, and risk management during R&D phases. Interface with suppliers and internal stakeholders to ensure quality requirements are met across the supply chain. Qualifications & Skills Bachelor’s degree in Biomedical, Mechanical, or related Engineering discipline; advanced degree preferred. 3+ years of experience in R&D engineering, with exposure to quality engineering or medical device product development. Solid understanding of design controls, validation principles, and medical device regulations (21 CFR 820, ISO 13485, ISO 14971). Proven ability to prepare structured technical documentation, protocols, and regulatory-compliant reports. Strong analytical and problem-solving skills, with proficiency in statistical tools (Excel, Minitab, or JMP). Excellent written communication and technical writing skills, with attention to detail. Hands-on lab or testing experience; catheter or capital equipment exposure is a plus. Preferred: ASQ CQE certification or equivalent quality credential. Why Join Us At the intersection of innovation and quality, this role offers the opportunity to shape products that directly improve patient outcomes. You’ll be part of a collaborative team empowered to push technical boundaries while ensuring rigorous quality oversight. We provide an environment where engineering creativity is matched with compliance excellence—ideal for those who thrive on balancing innovation and precision. Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering, Science, and Quality Assurance Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing Note: This refinement preserves the core job information and removes non-essential postings. It uses only allowed tags, fixes list structure, converts emphasis to bold, and presents content in clear sections.
#J-18808-Ljbffr