Product Engineer

Product Engineer (Design Control, Documentation)

Local Only

1-2 days onsite in Danvers, MA

12 months

W2 Only (No C2C)

Project: 

• Migrating Linux distributions from Kirkstone (v4) to Scarthgap (v5)
• Will be working with Impella Connect platform – remote link module connects to heart pump, module allows for wireless streaming of non-PHI data into the cloud environment
• This person will be overseeing all the documentation to support this migration process and supporting the same team our embedded software engineer is working on.

Profile:

• 3 years experience in medical device
• Experience with software as medical device preferred, will take any medical device experience
• Experience with software design history files, design controls, design reviews, writing requirements, document requirements, and change requests
• Experience with documentation supporting software product development software life cycle process
• Experience with JAMA or WRIKE (similar to Jira) preferred
• Experience with managing design history files in SAP

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.
• Support Design Assurance engineering activities in support of Abiomed’s Software Product Development and Software Life Cycle processes including design controls, quality planning, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting, product security