This position has the responsibility of working on teams to plan and execute R&D activities to support products in the field to ensure products maintain quality standards, comply with regulatory and compliance standards and have appropriate technical support for our sales and customer efforts. Job responsibilities include addressing well defined problems and following standard practices and procedures. This Product Support Software Engineer's responsibilities include maintaining hardware and software for medical devices.
Provides R&D engineering support for Quality and compliance activities including correcting quality problems in released product, compliance with new regulations and standards, support for Regulatory submissions for expansion into new geographies, and remediation of quality records.
Consults with the marketing staff, sponsoring surgeons, and manufacturing staff, as required, to facilitate proper design and development of agreed product improvements.
Prepares design specifications or drawings and acts as a consultant in the preparation of final or modified specifications or drawings.
Provides R&D engineering support on existing products to identify and mitigate any impact to design integrity from process changes or supplier/network changes.
Assist with unit testing and validation of software applications and complete hardware/software systems
Supports returned product labs, complaint investigations, retrieved component analysis, and post market surveillance with root cause analysis.
Provides technical support as required for existing products (e.g., sales training, product demonstrations, customer meetings, VSP's, tradeshows).
Supports R&D activities related to product obsolescence and end of life management for all assigned products
Other duties as assigned.
Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Mechanical Engineering or other related engineering field.
BS in Engineering or science +2 years experience or Masters +1 year of experience
CAD experience beneficial
Debugging reported product issues
Thorough understanding of FDA and MDR design control requirements for electronic and software controlled devices
Experience performing software validation for medical devices
Excellent analytical, problem solving and organizational skills
Ability to work effectively in a cross-functional team environment
High learning agility
Strong written and verbal communication and technical writing skills