Product Engineer Job Danvers area,Massachusetts USA,Engineering

Medical Device Product Engineer

Hybrid- living in Mass or New Hampshire so they're commutable to Danvers, Mass

recent 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 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.