Project Engineer

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 tool and produce required documentation for the design history file

• Track project performance, specifically to analyze the successful completion of short- and long-term goals

• Meet budgetary objectives and make adjustments to project constraints based on financial analysis

• Develop comprehensive project plans to be shared with management as well as other staff members

• Collaborates with team in identifying workflow and process gaps and issues

• Assists in backlog grooming and maintenance

• Organize and conduct reviews with stakeholders and development teams

• Coordinate cross-functional reporting across teams - ensuring inter-dependencies are documented, understood, and communicated.

• Use and continually develop leadership skills

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 1 year 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

A strong candidate will also have

• Experience supporting FDA regulated products

• Project Management Professional (PMP) Certification

• Experience working with Agile development with a Continuous Discovery/Delivery mindset

• Experience delivering SaaS

• Experience working directly with software engineers