Rewritten Job Title:

Lead Design Assurance Engineering Manager - Revolutionizing Medical Device Development

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].