Lead Design Assurance Engineering Manager - Revolutionizing Medical Device Development
**Rewritten Job Description:**
About the Role:
Join our team as a Lead Design Assurance Engineering Manager and play a pivotal role in shaping the future of medical device development. As a key member of our team, you will be responsible for leading the design assurance engineering function, ensuring the development of safe, effective, and high-quality medical devices that meet regulatory requirements.
Key Responsibilities:
- Lead the design assurance engineering function, ensuring compliance with regulatory requirements and industry standards.
- Develop and implement design control processes, including design input, output, and verification.
- Collaborate with cross-functional teams, including R&D, regulatory, and quality assurance, to ensure seamless integration of design assurance activities.
- Provide technical leadership and guidance to design engineers, ensuring they have the necessary skills and knowledge to develop high-quality designs.
- Develop and maintain technical documentation, including design specifications, test plans, and reports.
- Participate in design reviews and audits to ensure compliance with regulatory requirements and industry standards.
- Identify and mitigate design risks, ensuring the development of safe and effective medical devices.
- Stay up-to-date with regulatory requirements and industry standards, ensuring our designs meet the latest requirements.
Requirements:
- Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
- Minimum of 5 years of relevant technical experience, or advanced degree with 3 years of technical experience.
- Strong knowledge of software design, development, debug, and test practices.
- Experience using unit test frameworks, such as Google Test / Mock, and following a Test-Driven Development software practice.
- Familiarity with using static analysis tools.
- Experience developing software within the medical device industry.
- Experience using Git for source control and experience in a pull-request based workflow.
- Familiarity with CI/CD tools such as Jenkins, GitLab CI/CD, or Travis CI to automate the build, test, and deploy software products.
- Experience with medical device design controls (e.g. ISO 13485), risk analysis (e.g. ISO 14971), and IEC62304 and SDLC.
What We Offer:
- A competitive salary and flexible benefits package.
- A dynamic and inclusive culture that welcomes the challenge of life-long learning.
- The opportunity to work on cutting-edge medical device development projects.
- A collaborative and supportive team environment.
- The chance to make a meaningful impact on the lives of patients and healthcare professionals.
How to Apply:
If you are a motivated and experienced design assurance engineering professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].
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