Staff NPD Quality Engineer - Software

Noah Medical; San Carlos (CA); Hybrid; USD 117,000 - 177,000; Full time

Job summary

Join a pioneering company in medical robotics as a Staff NPD Quality Engineer. In this dynamic role, you'll provide essential guidance through the New Product Development cycle, focusing on Quality Engineering disciplines, particularly in software life cycle processes. This innovative firm is dedicated to transforming healthcare with cutting-edge robotic technologies, and they are looking for a motivated individual who thrives in a collaborative environment. If you're passionate about quality assurance and eager to make a significant impact in the medical device industry, this opportunity is perfect for you.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401k Plan

Paid Time Off

Paid Holidays

Life & Disability Insurance

Bonuses

Stock Options

Qualifications

• 6+ years in medical device engineering with 2+ years in development QE.
• Expertise in SLCP per IEC62304 and Quality Management Systems.

Responsibilities

• Lead Quality Engineering during New Product Development cycles.
• Define and implement Quality Management System to meet FDA requirements.

Skills

Quality Management System

Risk Management

Statistical Analysis

Software Life Cycle Process

Communication Skills

Education

Bachelor's in Engineering or Technology

Master's Degree (Preferred)

Tools

Microsoft Office

Google Suite

Jama

ePLM/eQMS systems

Job description

Staff NPD Quality Engineer - Software

San Carlos, California / Quality – Quality Assurance / Full-Time (Salary) / Hybrid

The Company

Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of 150+ engineers, innovators and industry leaders brings 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 & Hansen.

This position provides hands-on guidance and leadership from a Quality and Regulatory perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth; you must be a self-starter, team builder, and excellent communicator.

Responsibilities:

• Provide hands-on guidance and leadership throughout the New Product Development cycle in all Quality Engineering disciplines, specifically focus on Software Life Cycle Process per ISO-62304.
• Participate in product development teams and represent Quality and Regulatory function. Provide input to the product development planning process according to QMS implementation/requirements/trace matrix. Contribute to regulatory submissions.
• Define, implement Noah Medical’s Quality Management System to meet US FDA and International requirements.
• Provide hands-on leadership and guidance to Design Control requirements for software for medical device, DHF, Risk Management, SDP, SAD, Design Verification/Validation, test method validation (TMV), equipment software validation and computer system validation (CSV).
• Review and release change orders in the ePLM system and participate in design and phase reviews.
• Participate and represent Quality in issue triage, KAL, LOC, SW classification, cybersecurity management.
• Other QMS and Design Control activities not specified here and as assigned.

Requirements:

• Minimum BS in Engineering or Technology, Industrial, Electrical, Software, Life Sciences, etc.
• Minimum 6 years of Engineering work experience in the medical device field and a minimum of 2 years of experience in a development QE function or equivalent with focus on software for medical devices.
• Experience in meeting Design Control and DHF requirements with NPD teams.
• Must understand and practiced to SLCP per IEC62304.
• Well versed in the complete Quality Management System to meet US FDA, ISO13485, ISO14971, IEC60601, and IEC62304 requirements.
• Experience with Risk Management, FMEA, Hazard Analysis, requirements.
• Experienced with statistical skills to define/train on test sample size and data analysis techniques.
• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems.
• Must be a self-starter, team builder, and excellent in verbal and written communication.
• Preferred: Master Degree, EU MDR is a plus;
• Certifications: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditing, etc.

$117,800 - $176,800 a year Consistent with applicable laws, an employee's pay within this range is based on a number of factors which include but are not limited to relevant education, skills, job-related knowledge, qualifications, work experience, credentials, and/or geographic location. Noah Medical reserves the right to modify this range as needed. Please note that the aforementioned range is only one component of the position's total compensation package. In addition, this position may be eligible for bonuses, stock and employee benefits including but not limited to PTO, paid holidays, health insurance, dental & vision insurance, life & disability insurance and a 401k plan. Additional details on the compensation package and employee benefits offerings will be provided to candidates during the interview process.

Noah Medical is proud to be 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.

To all recruitment agencies: Noah Medical does not accept unsolicited 3rd party agency resumes. Please do not forward resumes to any Noah Medical employees. Noah Medical is not responsible for any fees related to unsolicited resumes and we will not pay fees to any third-party agency or company that does not have a signed agreement with Noah Medical.