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NPD Test Lead

NPD Test Lead

Katalyst Healthcares & Life Sciences

Burlington, MA

$51.75 - $70.50/hr

Contractor

Posted 3 days ago

Job description

Company Description
  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description

Responsibilities:

  • Lead end-to-end NPI activities for embedded software testing in medical devices.
  • Oversee Test protocols, test strategy and test automation testing aligned with IEC 62304 standards.
  • Manage and troubleshoot communication protocols including BLE, Serial, SPI, UART.
  • Utilize protocol sniffers and debugging tools to resolve technical issues.
  • Ensure compliance with FDA guidelines, SaMD testing protocols, and other regulatory standards.
  • Collaborate with cross-functional teams across onsite and offshore locations to resolve technical challenges.
  • Drive Software Testing Life Cycle (STLC) processes and ensure quality assurance.
  • Interface with regulatory bodies and support documentation for audits and submissions.
  • Communicate effectively with stakeholders, including engineering, QA, regulatory, and product teams.

Requirements:

  • Bachelor's or master's degree in computer science, Electronics, Biomedical Engineering, or related field.
  • 12+ years of experience in embedded software development and testing for medical devices.
  • Experience with Appium or any other mobile test automation framework.
  • Strong understanding of IEC 62304, FDA regulations, and SaMD standards.
  • Hands-on experience with BLE, Serial, SPI, UART communication protocols.
  • Proficiency in using protocol sniffers and debugging tools.
  • Proven experience managing offshore and onsite teams.
  • Excellent communication, leadership, and problem-solving skills.
  • Familiarity with STLC, risk management, and design controls.
  • Experience with cybersecurity standards for medical devices.
  • Knowledge of ISO 14971, ISO 13485, and other relevant standards.
  • PMP or similar certification is a plus.
Additional Information

All your information will be kept confidential according to EEO guidelines.

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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Test Lead?

A: To succeed as a Test Lead, one should possess technical skills such as expertise in software testing methodologies (e.g., Agile, DevOps), proficiency in testing tools and frameworks (e.g., Selenium, JUnit), and a solid understanding of programming languages (e.g., Java, Python). Additionally, strong soft skills like effective communication, leadership, and problem-solving abilities are crucial for guiding cross-functional teams, prioritizing testing efforts, and resolving complex issues. By combining these technical and soft skills, a Test Lead can drive high-quality testing, ensure timely releases, and foster a culture of quality assurance, ultimately supporting career growth and effectiveness in the role.

Q: What is the career path for a Test Lead?

A: A Test Lead typically starts as a Test Engineer or Quality Assurance (QA) Engineer, progressing to a Test Manager or Senior Test Engineer role, and eventually becoming a Test Lead or Director of Quality Assurance. Key opportunities for skill development include learning Agile methodologies, test automation, and leadership skills, as well as staying up-to-date with industry trends and emerging technologies. Long-term career prospects may include transitioning into roles such as Product Manager, Technical Program Manager, or even a Director of Engineering position, leveraging their expertise in quality assurance and testing to drive product development and innovation.

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Katalyst Healthcares & Life Sciences job posting for a NPD Test Lead in Burlington, MA with a salary of $52 to $71 Hourly with a map of Burlington location.