Software Medical Device Quality Engineer

Software Medical Device Quality Engineer - Job Description

About Norbert

Health care is in dire need of automation. 13m nursing jobs will be vacant by 2025, and it is urgent to reduce the workload of overworked nursing and medical staff. Healthcare needs automation to grow into the home as well - 265Bn worth of medicare costs are shifting from hospital to home by 2028. A seamless and automated solution for at-home medical monitoring is essential to this transformation.

Norbert Health has built the first contactless and automated vitals signs scanner that can measure heart rate, SpO2, temperature, breathing rate, pulse wave velocity in less than 20 seconds. All the patient needs to do is sit or stand within 4 feet of the device for 15 seconds. It is a sleek, plug-and-play, consumer grade device that is fully automated.

We are deployed in hospitals for pilots throughout the world, and are finalizing our bench tests before starting clinical trials in October.

Our founder Alex Winter is a pioneer and repeat entrepreneur in computer vision and machine learning, started, grew and exited to venture backed startups in the field.

We are venture backed by top tier VCs, headquartered in Brooklyn with offices in Paris, France.

Come join us to build the future of ambient, predictive health, saving lives and making people live longer and happier, at home.

The Position

We are looking for a strong and driven Software Medical Device Quality Engineer to execute and own software bench, verification & validation testing and portions of the Quality Management System. We are looking for a candidate who has a software background and would like to grow in Medical Device Quality Engineering.

The ideal candidate has some experience with medical device software engineering and a strong background in technical writing and software testing.

What you will do:

• Product and Systems Requirement Definition. Outlining inputs, outputs, test cases, expected results and processes for verifying or validating them.
• Generate software bench, verification, and validation protocols. Execute software testing and generate technical reports.
• Own or support software technical file documentation.
• Assessment of various international standards and regulations and assessing gaps, risk, and validation of adherence.
• Collaborate and coordinate across Software, Product and Hardware teams to validate requirement dependencies.
• Implementation and oversight of software change control and approval processes.
• Review procedures of the entire production cycle to ensure they are efficient and comply with specified standards.
• Support medical device Class 2 certification process.

What we look for:

• Ideally have experience in ISO13485 Medical Device Quality management processes
• Proficient technical writer with experience creating and executing software testing protocols
• Excellent knowledge and experience with quality control standards and testing methodologies
• Has worked with Software Driven Medical Devices that adhere to IEC 62304
• Experienced with Agile Software Methodologies
• Worked with an Electrical Lab Testing facility, such as UL or Intertek to certify Medical Devices in accordance to IEC 60601
• Close attention to detail and a results-driven approach
• Responsible, trustworthy and strong communicator
• Excellent problem-solving skills and attention to detail.
• Bachelor's degree in Computer Science, Engineering, or a related field.
• Fluent in English, both written and spoken; knowledge of French is a plus.

What we offer

• Strong independence and decision making
• Cutting edge, unique technology
• A talented, excellent, diverse and international team
• A very ambitious and mission-driven vision
• Strong incentive in the company’s future

Company Location/Policy:

For Brooklyn:

Location - onsite at NewLab in Brooklyn, NY

*Remote option available w/ 20-30% travel required for the right candidate.

Hiring Process

• Introduction call with our Quality Manager (30-min)
• Technical interviews
  • One homework to complete
  • On site / via Video chat : Homework review w/ Quality Manager & 1-2 Norbert Engineers
• Interview with our CTO
• Interview with our VP of Operations
• Interview with our CEO
• Reference Call
• Offer