Medical Device Business Analyst

POSITION

Medical Device Business Analyst

LOCATION

Must be local to go onsite to Danvers, MA 2 days a week

No relo

DURATION

This is a contract role that could turn into permanent down the line, so it's a plus if they don't require sponsorship now or in the future

9+ month contract (project deliverables for now until EOY)

INTERVIEW TYPE

Video

VISA RESTRICTIONS

None

REQUIRED SKILLS

Must come from a medical device company. No relo and no one that isn't from medical device

They're looking for a mid-level Business Analyst, please don't send anyone who has more than 6 years of working experience as they don't want the person to become bored and leave. This is junior/mid level work

Main focus of this project will be writing up requirements, producing the documents to support the project, tracking down signatures, and tracking project updates in their project management system

• Need strong medical device background

• Experience with EU Medical Device regulations

• A plus if they've worked on Design History File (DHF)

• Must have very strong communication skills!!!!!

JD
* this is the one sent from the client

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
• Limited travel might be required.

• 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