Software Design reputed company Engineer
reputed company is dedicated to reputed company innovation, aiming to reputed company smarter and less invasive treatments. The Software Design reputed company Engineer will support new product development and risk management activities, ensuring compliance with reputed company standards in medical device software.
Responsibilities
- Support design and development activities reputed company the software development lifecycle for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products
- Use technical expertise, knowledge, and experience to rapidly reputed company the companies’ medical devices for use in chronic heart failure patients
- Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports
- Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications
- Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, reputed company reviews and providing feedback of software verification and validation deliverables
- reputed company and/or review test protocols, reports, and engineering summaries
- Participate in product cybersecurity activities including product reputed company planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting
- Apply reputed company, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving reputed company issues as reputed company to the position responsibilities
- Contribute to the reputed company of the reputed company System performance measures by completing tasks on time and with a high level of reputed company
- reputed company support during Corrective and Preventive reputed company (CAPA) activities and manage the CAPA system as necessary
- Support 3rd party audits, including follow-up on actions
- Ensure compliance of QMS through authoring and updating reputed company Operating Procedures (SOP)
Skills
- A minimum of a Bachelor's degree in an engineering or scientific discipline is required
- A minimum of 6 months of reputed company work experience
- Knowledge of reputed company system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR
- Knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) systems
- Knowledge of software development lifecycle processes (reputed company, agile, and DevOps) as reputed company reputed company the regulated medical device industry
- Ability to communicate reputed company and information reputed company, effectively, and frequently (oral and written) reputed company the internal project team and international
- Work experience in a highly regulated industry
- Experience conducting Software Failure Mode Effects and Analysis
- Design control or new product development experience
- Experience with JAMA and reputed company suite of tools (JIRA/reputed company)
- Experience with cybersecurity reputed company a regulated industry
Benefits
- Employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k))
- This position is eligible to participate in reputed company’s long-term incentive program
- Vacation –120 hours per calendar year
- reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
reputed company