Project Engineer

TechDigital Group; Danvers (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the medical device industry is seeking a project manager with a Bachelor's degree in Engineering or Technology. The ideal candidate will collaborate with agile teams, manage project documentation, and ensure compliance with FDA regulations. Strong problem-solving skills and experience in the medical device sector are essential. The role requires excellent teamwork, time management, and the ability to meet tight deadlines. Limited travel may be required.

Qualifications

• Minimum of 1 year experience in the medical device industry.
• Demonstrates knowledge of quality policies and FDA/ISO requirements.

Responsibilities

• Collaborates with the agile team to translate business vision.
• Develop and manage the software design history file.
• Track project performance and analyze completion of goals.

Skills

Agile

Collaboration

Problem-Solving

Education

Bachelor's Degree in Engineering/Technology

Tools

JAMA

SAP

Job description

Skills Matrix
Skill	Last Used	Experience in Years/month	Rating (10 points) 1 = newbie 10 = expert	Hands on Exp. Yes/No
JAMA
Medical devices
FDA
SaaS
Agile

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