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

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.