Principal Systems Engineer

About the role

The Principal Systems Engineer will be responsible for system-level development and implementation of electronic, software, and mechanical designs for Class II and III medical devices. This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure).

Responsibilities

• Create requirements, engineering specifications, tests during the life cycle of the product development and develop technical solutions based on these requirements to be implemented by the different disciplines (electrical, mechanical, etc.).
• Apply medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485.
• Ensure that all requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability, and serviceability within the constraints of the project schedule and budget.
• Perform detailed design analysis and conduct regular design reviews with all the disciplines.
• Collaborate with program managers to create and manage development plans and project plans related to the development.
• Lead and contribute to creation of risk management documentation, including Failure Mode Effects Analysis.
• Develop and maintain documentation (e.g., specifications, designs, test plans and reports, etc.) required for medical product Design and Development Files.
• Aid in creation of manufacturing process instructions, bills of material, quality inspection, and related documentation.
• Lead product development meetings for the associated disciplines.
• Maintain Design and Development file and participate in periodic phase reviews.
• Create reports for the stakeholders.

Requirements

• A Bachelor’s degree in a STEM discipline.
• 10 years of relevant experience required.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Experienced with Quality Control principles and methodology.
• Meticulous attention to detail, including ability to maintain accurate records and traceability.
• Analytical reasoning and problem solving.
• Experience in developing requirements, engineering specifications, procedures.
• Team player and goal oriented.
• Knowledge of Agile development methodologies (Scrum, Kanban).

Qualifications

• Fluent English language skills.
• Excellent oral, written, and presentation communication skills.
• Prefer Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
• Knowledge of SysML, UML and MBSE, INCOSE ASEP or CSEP preferred.
• JAMA Product Development Documentation Management helpful.
• Prefer experience in electronics: analog, power and digital, oscilloscopes, general electronic test equipment.

Skills

• Knowledge of Quality Management System principles and methodology.

Benefits

Competitive market salary from $150,000 to $180,000 per year depending on qualifications and experience.

Pay

Competitive market salary from $150,000 to $180,000 per year depending on qualifications and experience.

Schedule

N/A

Benefits

Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off, 401(k) retirement savings with a company match.