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Sr. Design Assurance Quality Engineer- Software

San Carlos, California

Who We Are

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.

About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

This position provides hands-on technical guidance and leadership from a Quality perspective to the team throughout all stages of product development up to and including technology transfer and commercialization. We are looking for someone that is highly motivated and solution oriented; you must be a self-starter, team builder, and excellent communicator. This is a Full Time Salaried position.

A Day In The Life Of Our Senior Design Quality Engineer - Software

  • Support product development activities through application of design control processes in compliance with ISO 13485, 21 CFR 820, and IEC 62304.
  • Participate in design reviews, risk management activities, and verification/validation planning.
  • Review and approve test plans, protocols, and reports for design and manufacturing changes.
  • Collaborate with R&D, Manufacturing, and Regulatory to ensure smooth design transfer and sustained product quality.
  • Contribute to root-cause analysis, CAPA investigations, and non-conformance resolution.
  • Assist in maintaining the Design History File (DHF) and related design documentation.
  • Support internal and external quality audits and inspections.
  • Provide guidance on QMS procedures, work instructions, and best practices.
  • Monitor quality metrics, perform data analysis, and support continuous improvement initiatives.
  • Ensure appropriate traceability and documentation of design and quality deliverables.

About You

  • BS in Engineering, Life Sciences, or related discipline. 
  • Minimum of 5 years of Engineering work experience with a BS or a minimum of 2 years of Engineering work experience with a PhD in the medical device or similarly regulated industry. 
  • Preferred: minimum of 3 years experience in a development QE function in a regulated environment 
  • Experience in meeting Design Control and DHF requirements with NPD teams. 
  • Well versed in the complete Quality Management System to meet US FDA and ISO requirements with an emphasis on IEC 62304. 
  • Experience with Risk Management, FMEA, Hazard Analysis. 
  • Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems. 
  • Must be a self-starter, team builder, and excellent in verbal and written communication. 
  • Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc. 
  • Preferred: experience with statistical skills to define/train on test sample size and data analysis techniques.
  • Passionate about SW and technologies for healthcare

The expected salary range for this role is $123,000 to $154,000 per year, depending on experience and qualifications.

#LI-Hybrid

 

 

Benefits & Perks (For Full Time Employees):

  • Competitive Salary
  • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + sick time 
  • Paid parental leave
  • In-office snacks and beverages 
  • In-office lunch stipend
  • Learning & Development Opportunities: On-demand online training and book reimbursement
  • Team building and company organized social and celebration events

Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. 

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.

Please visit our Careers Page to view our latest openings.

NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition.  Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.

 

 

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