Product Engineer
3b staffingDanvers (MA)
About the role
Medical Device Product Engineer
Hybrid:
living in Mass or New Hampshire so they're commutable to Danvers, Massrecent medical device documentation experience, and will be doing just the documentation for this project Minimum of 3 years experience in the medical device industry as well Medical Device Software systems and cardiovascular devices preferred but not required (Class III medical device experience strongly preferred)WRIKE is their version of Jira 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 SAPMaintain 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.
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