Okay, I've searched for Embedded Device Test Engineer roles in Cambridge, MA within the medical device industry, focusing on contract positions, and requiring experience in FDA regulations and embedded systems. I have found 56 positions for you.

Sure. Here's the analysis:

Job Analysis:

The role of the Embedded Device Test Engineer is fundamentally about ensuring the reliability and compliance of medical devices through rigorous testing. This position is crucial in the context of both safety and regulatory adherence, particularly given the complexities associated with FDA regulations such as IEC 62304 and 21 CFR Part 820. The key responsibilities include executing and developing test strategies for embedded systems, managing large-scale distributed testing environments, and applying knowledge of Linux and Windows operating systems. The candidate will often need to coordinate cross-functionally with software developers and compliance teams, implying that strong communication and collaboration skills are just as vital as technical prowess. Success in this role requires not only technical skills but also the ability to anticipate potential issues in device functionality and regulatory compliance, demonstrating a comprehensive understanding of the product lifecycle in medical device development. In the first 6–12 months, success might be measured by the candidate’s ability to create and implement effective testing protocols that are both time-efficient and compliant, ultimately contributing to timely product launches and regulatory approvals.

Company Analysis:

Tekskills Inc. occupies a robust position within the technology consulting industry, specializing in comprehensive solutions for digital transformation. With a focus on innovative IT services, their status as an ISO 9001:2015 certified and CMMI Level 3 appraised organization reflects their commitment to quality and process maturity. This role is notably situated within a culture that values high standards in technical execution and compliance, crucial in the context of their work with Fortune 500 companies and other global clients. The team dynamics likely lean towards collaboration and adaptivity, given their engagement in diverse projects across various geographies. The Embedded Device Test Engineer is expected to engage closely with product development teams and other stakeholders, making their input critical as the company drives forward its multidimensional service offerings. This position is not just an isolated technical role; it plays a strategic part in assuring compliance and quality, essential for maintaining the trust of both clients and regulatory bodies.

Absolutely. Here are some mock interview questions that could come up:

• Tell me about a time when you had to develop a testing strategy for a medical device. What challenges did you face and how did you overcome them?
• Can you describe your experience with FDA regulations such as IEC 62304 or 21 CFR Part 820 and how you ensured compliance during testing?
• What methods do you use to stay organized while managing multiple testing tasks in an Agile environment?
• How would you approach developing a regression test suite for an embedded device operating in a real-time environment?
• Given your experience with scripting languages like Python, how would you automate specific testing tasks in this role?
• What steps would you take to test a device that incorporates both TCP/IP and wireless technologies?
• Imagine you are testing a medical device and discover a significant compliance issue. How would you handle that scenario?
• If given a new embedded system to test, what factors would influence your test plan development?
• Why are you interested in working at Tekskills Inc., particularly in the context of your past experiences?
• How do your personal values align with the mission of Tekskills Inc. to provide innovative solutions for clients?
• What do you think are the most important qualities for someone succeeding in a fast-paced, technology-driven consulting environment?
• Are there specific tools or methodologies you’ve used in your past roles that you believe would benefit this position?
• What questions do you have about the team structure and workflow at Tekskills Inc.?