Principal Systems Engineer

Position Overview

Cirtec Medical Corporation, a leading outsourcing partner for complex medical devices for over three decades, is seeking a Principal Systems Engineer to drive system-level development and implementation of electronic, software, and mechanical designs for Class II and III medical devices. In this high-energy, fast-paced role, you will collaborate with multidisciplinary teams to ensure high-quality and on-time product introductions while fostering innovation and continuous improvement.

Key Responsibilities

• Create requirements, engineering specifications, and tests during the product development life cycle.
• Apply medical development standards such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, and ISO 13485.
• Ensure that all hardware and software requirements and specifications are met to maximize performance, reliability, and serviceability within project schedule and budget constraints.
• Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams.
• Collaborate with program managers to create and manage development and project plans for electronic and software systems.
• Lead and contribute to the creation of risk management documentation, including Failure Mode Effects Analysis.
• Develop and maintain documentation (e.g., specifications, designs, test plans and reports) required for medical product Design History Files and support manufacturing process instructions and quality documentation.
• Participate in product development meetings and design and risk analysis reviews.
• Specify and assemble hardware for tests and maintain the design history file with periodic phase reviews.
• Create reports and test logs for stakeholders while providing inputs to improve device design and test outcomes.

Required Qualifications

• A Bachelor’s degree in a STEM discipline.
• 10 years of relevant experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Meticulous attention to detail with the ability to maintain accurate records and traceability.
• Familiarity with Quality Control principles and methodologies.
• Strong analytical reasoning and problem-solving skills.
• Experience in developing requirements, engineering specifications, and procedures.
• Team player with a goal-oriented mindset.
• Knowledge of Agile development methodologies (Scrum, Kanban).
• Fluent in reading, writing, and speaking English.
• Understanding of Quality Management System principles and methodology.
• Excellent oral, written, and presentation communication skills.

Preferred Qualifications

• Experience with active and passive implantable devices and peripherals for Class III medical devices.
• Proficiency in SysML, UML and MBSE, with INCOSE ASEP or CSEP credentials preferred.
• Familiarity with JAMA Product Development Documentation Management.
• Experience in electronics including analog, power and digital systems, and use of electronic test equipment.

Benefits & Perks

• Competitive market salary: $150,000 to $180,000 per year based on qualifications and experience.
• Training and career development opportunities.
• Healthcare and well-being programs including medical, dental, vision, wellness, and occupational health programs.
• Paid Time Off and a 401(k) retirement savings plan with a company match.