What are the responsibilities and job description for the Medical Device Product Engineer position at Novia Infotech?
Key Responsibilities
- Collaborates with the agile team to translate the business vision into language that can be consumed by development resources.
- Develop and manage the software design history file
- Support Project Documentation and Materials needs via SAP
- Maintain JAMA/WRIKE tool and produce required documentation for the design history file
- Track project documents specifically to analyze the successful completion of short- and long-term goals
- Develop comprehensive project plans to be shared with management as well as other staff members
- Assists in backlog grooming and maintenance
- Organize and conduct document reviews with stakeholders and development teams
- Lead the analysis of project requirements and help define project scope and objectives, ensuring technical feasibility.
- Ensure adherence to quality standards and regulatory requirements throughout the project lifecycle
- Drive project deliverables by ensuring alignment with company SOPs and effectively communicating timelines and dependencies to cross-functional teams and leadership to foster collaboration and alignment.
Job Qualifications
- Bachelor’s Degree in Engineering/Technology
- Self-reliant; takes initiative; results-oriented; collaborative
- Capable of managing time and project assignments with minimal oversight
- Ability to meet tight deadlines in an environment of competing priorities
- Proven commitment to proactive planning, thoroughness, and excellent execution
- Well organized, detail oriented, highly analytical, possess strong problem-solving skills and must have a desire to be accountable for project success
- Excellent team-work and coordination, professionalism and discipline
- Minimum of 3 years experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)
- Demonstrates knowledge of quality policies, principles and best practices and FDA/ISO requirements
- Excellent verbal and written communication skills, capable of tailoring messaging for diverse audiences and establishing trust with stakeholders throughout the organization.
