Product Engineer(Medical Device)

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Hope you're doing well!!

Please find the requirement below. If you find yourself comfortable with the requirement please reply back with your updated resume or call me back at

Position : Product Engineer(Medical Device)

Location : Danvers, MA (Hybrid)

Duration: 6 months

Client won't be able to sponsor any visa

REQUIRED SKILLS

• recent medical device documentation experience, and will be doing just the documentation for this project

• Strong and recent Medical device documentation experience
  • 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)
• Contract is until end of the year
• WRIKE is their version of Jira
• Manager made it clear this is mostly documentation focused role

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

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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