Product Engineer

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

• 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.

• 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.