Medical Device Quality Engineer
Medical Device Quality Engineer
Posted on :
06-09-2024
Employer Active
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
We are seeking a Medical Device Quality Engineer (Onsite) for a fulltime role in Delray Beach FL. This is with a fastgrowing biomedical company in the oncology and biomedical IT field.
This is an inhouse role where you will develop and maintain medical devices in a dynamic and fast paced environment. You must have a strong attention to detail a strong understanding of regulatory requirements and a commitment to ensuring the quality and safety of software used in medical devices.
Responsibilities:
- You will design and implement quality assurance processes such as creating test plans conducting testing and ensuring that software defects are identified and addressed. You must ensure that the software developed for medical devices meets the required quality standards.
- You will be responsible for ensuring that the software development processes and products comply with regulations. You must adhere to strict regulatory requirements such as the ISO 13485:2016 FDAs regulations (e.g. 21 CFR Part 820) EU MDR and MDSAP regulations.
- You will work closely with software developers and be the lead for software verification and validation. You will engage with quality assurance and operations teams regulatory affairs professionals and other stakeholders to ensure that software development processes meet regulatory requirements and quality standards.
- Risk Management is crucial so you will be involved in identifying and mitigating risks associated with the software used in medical devices to ensure patient safety.
- Documentation is key so you will be responsible for creating and maintaining documentation related to software development processes testing procedures and all quality assurance activities.
- Continuously improve and enhance product quality to comply with evolving regulations by identifying opportunities for process improvement and implementing best practices to enhance software quality.
- Responsible for ensuring the quality and safety of software used in medical devices.
Requirements:
- 2 years of experience with active medical devices like Electromechanical and Xray
- Knowledge of ISO 13485:2016 is required
- FDAs regulations like 21 CFR Part 820 EU MDR and MDSAP regulations are a plus
- Experience with software verification and validation for software QA testing
- Strong knowledge of the software development life cycle (SDLC)
- Experience with code repositories like Git
- Experience following code paths
- Experience with OOP architecture
- Understanding and the ability to follow the code with Java C NodeJs and JavaScript is a plus.
- Experience with MySQL databases UML diagrams and Jira is a plus.
- Minimum of Associate or BS degree in Computer Science Software Electronics Electrical Engineering or Equivalent
All qualified applicants will receive consideration for employment without regard to race color national origin age ancestry religion sex sexual orientation gender identity gender expression marital status disability medical condition genetic information pregnancy or military or veteran status. You must be legally authorized to work in the United States without current or future sponsorship.
My notes:
- Role: This role reports to the Director of Quality Assurance and Regulatory Affairs Raul Gonzales who just started in June 2024. He was their auditor last year and then they hired him on. This role is a hybrid role where they will test the medical device and help with quality for software validation and verification. They will do validation and verification and the test scripts are already written. They will help add new test cases. Must have creativity to understand the software industry to find new test cases to add to the list. There are regulatory rules behind this so they need to be well versed on the regulations. Should be well acquainted with software validation overall but they will not be writing code. They need to be good at documentation and should know the regulations (they will teach if needed). They should be excited about a role like this and willing to absorb info well. Should have core knowledge to ensure what they are documenting and writing are within scope of regulations. They specifically need ISO 13485:2016. This role is quality and regulatory and they will be supporting the technical team (Emis group) and Maggies group for computer systems regulation. They wont be coding or programing so its only a plus. They will help with audits and maintain the quality system. This is all manual testing for now and a lot of physical testing. No one is doing this now. They need to be onsite working on the device and hand in hand with the C# Software Engineers to support the product. This is open due to growth.
- Team: They will be the only one in a role like this and they will be a hybrid between 2 teams. There are 8 developers locally that they will work with.
- Must Have: ISO 13485:2016 is needed and other regulations are a plus. Medical device industry experience is preferred. but they are open to someone from a pharma background as well because there are a lot of similarities.
- Training: typically it takes 12 weeks depending on experience. Maybe another week to learn procedures.
- Work hours: 95 but not set schedule
- Interview: Send resumes to Raul (Dir of QA) Maggie (COO) Emiliano Emi (CTO). 1st interview will be video or in person with Raul and Emi. 2nd is to meet with a few other members of the team that they might work with like Maggie president general counsel or CEO.
- Onsite/Remote: full time onsite.
- Personalities: They are a smaller company that is all in person they need someone that is good working with a group and not autonomously. Knows how to talk to people and communicate well. Must be able to work with other departments. Dont need to be super bubbly but need to interact closely with others. They should be collaborative cross functional and have attention to detail. They are like a close family there and the people are nice.
- Industry: Medical Equipment Electronics Healthcare Health Services
- Salary/Bonus: $65000$75000/Year plus performance bonus at the end of the year (not sure %)
Company Notes:
- Overview: They are a medical device company specializing in highly effective noninvasive minimallyinvasive and costeffective treatments for both oncological and nononcological conditions. Offering proprietary lowenergy Xray technology known as superficial radiation therapy (SRT) which is the culmination of more than a decade of research and development to treat nonmelanoma skin cancers and keloids with its SRT100 SRT100 and SRT100 Vision systems. With its portfolio of innovative medical device products Sensus provides revolutionary treatment options to enhance the quality of life of patients around the world. The Sculptura robotic radiation oncology system provides targeted intraoperative triplemodulated radiotherapy (IORT) and Brachytherapy utilizing our proprietary stateoftheart 3D Beam Sculpting to treat patients undergoing cancer treatment during surgery or at the tumor site with a single dose. Sensus Smart Lasers powered by Sentinel is the worlds first ever Smart Lasers. Data Backup Remote Monitoring for 5 aesthetic lasers. TransDermal Infusion delivers HA Botox Fillers Hair Restoration PRP & more without needles downtime. Their headquarters are in Boca Raton FL Florida and they were founded in 2010. Their website is to learn more. They have about 500 devices in total and they work mostly in the US (90% of business right now). They work with dermatology practices and some hospitals.
- Main Devices: Their main one is called SRT and its FDA approved to treat skin cancer and keloids but their device was also used early on in covid to help treat Covid pneumonia in low doses (not FDA approved yet). The other big one is called Sentinel and it connects to devices in the field to collect data. Basically it helps them fix potential issues before they become a problem and help them figure out future things to make their product better.
- Employees: They have about 50 employees in the company. They have 18 in their headquarters in Boca (all have their own office) some in the field and some in Israel. They have about 20 sales reps and are hiring a ton of Radiation Therapist.
- IT team: They currently have 1 main person that is their C# developer that does the GUI and main interface for their main device. They also have 3 Web/iOS Developers in Israel. They are adding 3 more to the team now. Those are a Full Stack Software Engineer C# Software Engineer and a QA Engineer.
- Personalities: They like someone who can joke is fun loving likes pranks and arent too serious.
- Benefits: They have 401K match good health coverage. They have Cigna and it kicks in 30 days after you are hired. They start with 2 weeks of PTO at the beginning plus all the major holidays. Plus they treat you like an adult. Computer cell phone.
- Staffing: They do work with one other agency that charges a flat rate of $15K per Radiation Therapist. Theyve filled some roles but they dont send a lot of candidates and Madison isnt a fan of their communication. We are at $20K/placement.
- Remote/Onsite: mix depending on role.
- Hiring Managers:
- Madison Foti: Shes the Director of Customer Support and reports to Maggie (COO). Shes been there since 2016 and someone that weve personally known since 2015. Shes originally from Roanoke VA but lives in Boca now. Her Linked IN is
- Monica DiGioia: She lives in Daytona Beach FL and has been with them since 2014. Her Linked In is She is the VP of Clinical Applications and she oversees all of the Radiation Therapist. Has a team of 5 under her but that will be growing significantly with the new RTTs. Shes spearheading the entire program with Madison.
Original Job Description:
Title: Software Quality Engineer
Reports to: Director of Quality Assurance and Regulatory Affairs
Primary Location: Boca Raton FL
Base Pay: $65000$75000/Year
Employment Type: FullTime
Education: Minimum of Associate or BS degree in Computer Science Software Electronics Electrical Engineering or Equivalent
Experience: 2 Years of experience with active medical devices: XRay Electromechanical Software a plus
Manages Others: No
Relocation: No
Industry: Medical Equipment Electronics Healthcare Health Services
Sensus Healthcare is the leading manufacturer of superficial radiotherapy devices that are
FDA cleared to treat nonmelanoma skin cancers and keloids. Our device portfolio includes the SRT100 SRT100 and SRT100 Vision which utilize proprietary low energy X1ray technology known as superficial radiotherapy (SRT) the products of over a decade of dedicated research and development. Sensus currently has over 700 devices treating in practices across the United States and over 100 devices overseas. SRT is primarily used within the dermatology and plastic surgery spaces with a growing market within the Radiation Oncology space.
Job Description:
Sensus is hiring an inhouse Software Quality Engineer reporting to the Director of Quality Assurance and Regulatory Affairs. A Software Quality Engineer at a medical device company can be both demanding and fulfilling. It requires attention to detail a strong understanding of regulatory requirements and a commitment to ensuring the quality and safety of software used in medical devices.
Unique opportunity to join a fastgrowing biomedical company in the oncology and biomedical IT field to develop and maintain medical devices in a dynamic and fast paced environment.
Primary Responsibilities:
- Regulatory Compliance: Working in the medical device industry means adhering to strict regulatory requirements such as the ISO 13485:2016 FDAs regulations (e.g. 21 CFR Part 820) EU MDR MDSAP regulations. As a software quality engineer you would be responsible for ensuring that the software development processes and products comply with these regulations.
- Quality Assurance: Your role would involve designing and implementing quality assurance processes to ensure that the software developed for medical devices meets the required quality standards. This includes creating test plans conducting testing and ensuring that software defects are identified and addressed.
- Risk Management: In the medical device industry risk management is crucial. You would be involved in identifying and mitigating risks associated with the software used in medical devices to ensure patient safety.
- Documentation: Documentation is a key aspect of quality assurance in the medical device industry. You would be responsible for creating and maintaining documentation related to software development processes testing procedures and quality assurance activities.
- Collaboration: As a software quality engineer you would work closely with software developers as the lead for software verification and validation engage with quality assurance and operations teams regulatory affairs professionals and other stakeholders to ensure that software development processes meet regulatory requirements and quality standards.
- Continuous Improvement: Continuous improvement is essential in the medical device industry to enhance product quality and comply with evolving regulations. As a software quality engineer you would be involved in identifying opportunities for process improvement and implementing best practices to enhance software quality.
- Responsibility: Working in the medical device industry comes with a high level of responsibility due to the critical nature of the products being developed. Ensuring the quality and safety of software used in medical devices is paramount and as a software quality engineer you play a crucial role in this process.
Position Requirements:
- Minimum of Associate or BS degree in Computer Science Software Electronics Electrical Engineering or Equivalent
- Experience following code paths
- Experience with OOP architecture
- Strong knowledge of the software development life cycle
- Experience with code repositories (Git preferred)
- Knowledge of ISO 13485:2016 FDAs regulations (e.g. 21 CFR Part 820) knowledge of EU MDR MDSAP regulations a plus
- Experience in Software Verification and Validation Software QA Testing
Desired Qualities
- Understanding Java C NodeJs JavaScript
Ability to follow the code
- MySQL databases
- UML diagrams
- Experience with Jira
Benefits:
- Paid Time Off
- Medical/ Dental Insurance
- 401(k)
Remote Work :
No
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
