Description
Supervisor鈥檚 Title: Senior R&D Engineering Manager 聽
Exempt Status: Exempt
Location: Must be able to work onsite at the Burnsville location 聽
Compensation: The expected salary for this Minnesota-based position is $110,000-$140,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate鈥檚 knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).
Basic Function聽
The Senior Software Engineer will be responsible for developing software that is used in capital equipment products. This position鈥檚 work will directly support real-time navigation, device control, and electrophysiology workflows inside the MRI environment, enabling safer, radiation free cardiac interventions. 聽This position may involve other duties from time to time that are not listed below. This position is responsible for complying with the Quality System requirements and carrying out responsibilities outlined in the environmental, health, and safety policies.
Responsibilities
Responsible for product development:
路 Develops software used in Imricor products, ranging from firmware to User Interface.
o Works closely with hardware, software, quality, regulatory, and clinical teams to define requirements and drive product innovation.
o Develops software following best practices for reliability, safety, and scalability and in full compliance with IEC 62304 and FDA Class II/III device requirements.
o Develops automated tests, unit tests, integration tests, and supports verification and validation (V&V) activities.
o Supports design transfer, manufacturing, and posts market software updates.
o Analyzes field data, customer feedback, and defect trends to drive continuous improvement.
o Generates and maintains documentation including software requirements, architecture, design specifications, traceability, and risk analysis.
路 Participates in product development projects, including:
o Ensures products are developed per Imricor鈥檚 Quality Management System.
o Ensures that projects are completed per Imricor鈥檚 Design Control processes.
o Ensures product development timeline goals are being met.
路 Works with Marketing to ensure customer requirements are met.
路 Works with Operations to ensure manufacturability of products.
路 Mentors other engineers on good engineering and testing practices.
Responsible for software used within manufacturing:
路 Develops and verifies custom software that is used within the Operation department for manufacturing finished products when needed.
Requirements
Basic Qualifications
- Bachelor of Science in computer science, 聽聽聽聽聽software engineering, or related technical field; advanced degree 聽聽聽聽聽preferred.
- Minimum of 5 years of development 聽聽聽聽聽experience in the medical device industry.
- Strong proficiency in Java, C/C++, RTOS, 聽聽聽聽聽and microcontrollers for embedded systems.
- Experience 聽聽聽聽聽with Azure DevOps, code analysis tools, and software lifecycle processes a 聽聽聽聽聽plus.
- Experience with FDA 510(k), PMA, EU 聽聽聽聽聽MDR technical documentation and cybersecurity standards, or post market 聽聽聽聽聽surveillance.
- Demonstrated ability to effectively 聽聽聽聽聽and clearly communicate concepts, ideas and knowledge to other individuals 聽聽聽聽聽and teams.
- Strong analytical and problem-solving 聽聽聽聽聽skills, and comfortable working with and seeking optimum solutions with 聽聽聽聽聽team members in adjacent disciplines of engineering.
- Previous start-up experience, a plus.
Working Conditions
路 Light work, exerting up to 20 lbs. of force or less.
路 Requires fingering, repetitive motion, talking, and hearing.
路 85% of the time requires viewing and working on a computer screen.
路 Significant work pace & pressure due to deadlines.
The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
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