Project Engineer-Medical Device

Project Engineer Medical Device (Danvers, MA | Onsite)
Location: Danvers, MA (Day 1 Onsite)
Duration: 1 Year
Industry: Medical Device / Healthcare

Key Responsibilities:
Collaborate with agile teams to translate business visions into actionable development tasks.
Develop and manage the Software Design History File (DHF) in compliance with FDA regulations.
Utilize the JAMA tool to maintain and produce required documentation for the DHF.
Support project documentation and materials management needs via SAP.
Track project performance, analyzing the successful completion of short- and long-term goals.
Meet budgetary objectives and adjust project constraints based on financial analysis.
Develop comprehensive project plans to be shared with management and other staff members.
Identify workflow and process gaps, assisting 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 and communicated.

Required Qualifications:
Experience in the medical device industry, particularly with medical device software systems.
Experience with cardiovascular devices is highly preferred.
Class III medical device experience is strongly preferred.
Proficiency in using JAMA for requirements management.
Familiarity with SAP for project documentation and materials management.
Strong organizational, analytical, and problem-solving skills.