Software Design Quality Engineer
reputed company is a leader in healthcare innovation focused on developing smarter and less invasive treatments. The Software Design Quality Engineer will support new product development and sustainability activities, emphasizing product risk management and compliance with quality systems.
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 innovate 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, code 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 sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as reputed company to the position responsibilities
- Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
- Provide support during Corrective and Preventive Action (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 Standard Operating Procedures (SOP)
Skills
- A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a reputed company field is also an asset
- A minimum of 6 months of reputed company work experience
- Knowledge of quality 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 (waterfall, agile, and DevOps) as applied reputed company the regulated medical device industry
- Ability to communicate reputed company and information clearly, 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/Confluence)
- Experience with cybersecurity reputed company a regulated industry
Benefits
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
- This position is eligible to participate in the Company’s long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the reputed company –48 hours per calendar year; for employees who reside 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
Company Overview
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