About the position
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. 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.
Responsibilities
- Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
- Understand clinical applications, workflow and user needs.
- Review software related verification and validation strategy for the R&D organization and ensure compliance to the execution of the strategy.
- Serve as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.
- Review test plans, and test cases based upon the product and component level requirements.
- Partner with Human Factors SMEs and R&D to assess the usability of the software throughout design and development.
- Review and approve V&V system maintenance such as reworks and modification and tracking related to software upgrades.
- Review root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
- May perform audits of Design History Files and support both internal and external audits.
- Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
- Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
- Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.
- Maintain trained status for and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
- Apply and promote best-practice use of statistical tools and techniques throughout the organization.
- Other QMS activities not specified here and as assigned.
Requirements
- BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
- Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 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.
Nice-to-haves
- Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc.
- Experience with statistical skills to define/train on test sample size and data analysis techniques.
- Passionate about SW and technologies for healthcare.
Benefits
- 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
