Senior Systems Architect

2 weeks ago

Winter Park, Florida, United States Katalyst HealthCares and Life Sciences Full time
Position Overview Key Responsibilities:
  • Provide overall technical guidance and accountability for the development of innovative product releases and ongoing support activities.
  • Interpret user needs, manage requirements, conduct top-level design, assess feasibility of potential solutions, and break down derived requirements.
  • Oversee systems design/architecture and integration processes.
  • Facilitate New Product Introduction (NPI) initiatives that enhance value for the Clinical Applications and Devices Organization through innovative design, while ensuring high-quality engineering outcomes.
  • Act as the technical liaison for the program.
  • Manage defects and risks, and conduct design reviews.
  • Possess extensive knowledge in risk management in accordance with ISO standards.
  • Demonstrate expertise in developing and testing products to meet IEC Safety standards.
  • Exhibit in-depth knowledge in developing and testing products to comply with IEC62336 EMC standards.
  • Have experience in deriving and simulating human-device interactions and usage conditions.
  • Familiarity with electronic requirement data management software, preferably DOORS.
  • Bring a minimum of five years of engineering or R&D experience in a quality-focused environment.
Qualifications:
  • Collaborate with a team of highly skilled engineers dedicated to creating top-tier healthcare solutions.
  • Contribute to a work environment and culture focused on enhancing lives.
  • Hold a BS degree in engineering.
  • Demonstrate experience in leading product development in medical or other regulated industries.
  • Exhibit a track record of guiding teams to resolve complex challenges.
  • Show experience in deriving and simulating human-device interactions and usage conditions.
  • Have experience with electronic requirement data management software, preferably DOORS.
  • Accumulate a minimum of five years of engineering or R&D experience in a quality-driven environment.
  • Possess at least three years of experience in a Systems Engineering role or a role with comprehensive systems responsibility encompassing electrical (analog and digital), mechanical, firmware, and software development disciplines.
  • Exhibit excellent skills in requirements and specification documentation.
  • Demonstrate a profound understanding of US and international regulatory requirements for heavily regulated products.
  • Ability to establish and maintain effective cross-functional and cross-organizational relationships.
  • Possess strong oral, written, and presentation skills.
  • Have extensive knowledge in risk management per ISO standards.
  • Show expertise in developing and testing products to meet IEC Safety standards.
  • Exhibit in-depth knowledge in developing and testing products to comply with IEC62336 EMC standards.

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