Clinical Systems Architect
2 weeks ago
As a vital member of our team at Saxon Global, you will take on the role of a Clinical Systems Architect, where your expertise will drive the innovation and development of cutting-edge healthcare solutions.
Key Responsibilities- Technical Leadership: Provide overall technical guidance and accountability for the launch of new products and ongoing enhancements.
- User Requirements Translation: Convert user needs into actionable requirements, manage these requirements, and oversee top-level design and feasibility assessments.
- Systems Design and Integration: Lead systems architecture efforts and ensure effective integration across various disciplines.
- New Product Introduction Support: Contribute to initiatives that enhance value for the Clinical Applications and Devices Organization through innovative design and high-quality engineering solutions.
- Program Liaison: Act as the technical point of contact for the program, facilitating communication and collaboration.
- Risk Management: Oversee defect and risk management processes, including conducting design reviews.
To excel in this position, candidates should possess the following:
- Bachelor's degree in engineering or a related field.
- Proven experience in leading product development within regulated industries, particularly in the medical sector.
- Strong capability in guiding teams towards solutions for complex engineering challenges.
- Experience in simulating human-device interactions and understanding device usage scenarios.
- Familiarity with electronic requirement data management software, preferably DOORS.
- A minimum of five years of engineering or R&D experience in a quality-driven environment.
- At least three years in a Systems Engineering role, encompassing responsibilities across electrical, mechanical, firmware, and software development.
- Exceptional skills in writing requirements and specifications.
- Thorough understanding of US and international regulatory standards for heavily regulated products.
- Ability to cultivate and maintain effective relationships across various functions and organizations.
- Strong oral, written, and presentation communication skills.
- In-depth knowledge of risk management practices per ISO 14971.
- Expertise in developing and testing products according to IEC Safety and IEC62336 EMC standards.
- Familiarity with US and international regulatory frameworks for medical devices is highly desirable.
- Experience in developing reliability plans.
- Knowledge of product development methodologies and best practices.
- Understanding of verification and validation testing processes.
- Background in electrical or software development is advantageous.
- A Master's degree is preferred.
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