Sr. Systems & Software Engineering Manager at Cirtec Medical in Park Rapids, MN
Summary:
The Sr. Manager, Systems & Software Development will be responsible for leading the systems and software engineering functions for Class II/III medical device development programs. You will be an integral member of our product development team and will be responsible for providing leadership to our team of highly skilled engineers.
Responsibilities:
Lead, and serve as high-level individual contributor in, product development of Class 2/3 active implant systems and complex electromechanical devices. Lead and grow a team of skilled software engineers and systems engineers, and provide guidance and mentorship to direct reports. Lead and guide systems engineering team in creation of system architecture design, identify interfaces between sub-systems, development and management of product requirements and test specifications based on customer needs, applicable regulatory standards and design control requirements. Lead and guide software engineering team to specify, implement and verify embedded software, firmware and other software applications for the product. Serves as the principal technical contact with the customers and communicates directly with customers to understand project / product needs, and present technical updates, risks and issues. Work cross functionally with program management, quality, manufacturing, regulatory and other engineering teams to manage product design, risk management and system integration activities. Lead development and execution of engineering-level and verification testing, including coordination and management of external test houses. Lead development and implementation of off-the-shelf and custom ATE and other test systems for design verification and in-process testing during production. Participate in technical design reviews and development phase end reviews. Collaborate with program management to create and manage development plans and project plans related to software and systems development. Collaborate with cross-functional team to manage creation and maintenance of Design History file per Cirtec procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements. Research market and competition on an ongoing basis to ensure that Cirtec has cutting edge technologies and capabilities. Collaborate with Business Development and Applications Engineering teams to communicate Cirtec's capabilities to new customers and assist in generation of proposals and quotes. Reliable, consistent and punctual attendance is an essential function of the job. Other duties as assigned. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Qualifications:
BS or advanced degree in Computer Science, Computer Engineering, Electrical Engineering or an equivalent engineering discipline. 10
years' experience developing medical devices and 5
years' experience leading and/or managing engineering teams. Experience with development of active implantable or neuromodulation systems highly preferred. Demonstrated expertise in systems and software design and implementation. Experience and demonstrated expertise in formal systems engineering methodologies (e.g.:
system architecture development and requirements management). Familiarity with key medical device regulatory standards, for e.g. IEC 60601, IEC 62304, etc. Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral. WORKING ENVIRONMENT Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. EEO STATEMENT Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer.
Salary Range:
$200K -- $250K
Minimum Qualification
Systems Architecture & Engineering, Software Development, Technology ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
