Senior Project Engineer, Sustaining Engineering

Responsibilities

• Lead end-to-end project execution for complex medical device systems that integrate capital equipment, disposables, and embedded software components.
• Develop and manage comprehensive program plans, including scope, schedules, budgets, and resource allocation, to deliver new product development projects on time and within budget.
• Oversee design control activities, ensuring robust documentation, traceability, and regulatory readiness.
• Contribute to design history files (DHF), technical documentation, and submission packages.
• Facilitate phase gate reviews and ensure documentation meets quality and regulatory standards.
• Track and report on key program metrics, escalate issues appropriately, and drive resolutions.
• Collaborate with cross-functional teams (R&D, Quality, Regulatory, Clinical, Operations, and Commercial) to drive project execturion.
• Serve as the primary point of contact for project communications, both internally and externally, including with senior leadership and strategic partners.
• Provide engineering expertise to support feasibility, prototyping, and manufacturing scale-up.
• Develop and review detailed design documentation, drawings, and specifications.
• Participate in design reviews, hazard analyses, and failure mode effects analyses (FMEA).
• Support Design for Manufacturability (DFM) and Design for Assembly (DFA) efforts.
• Support design transfer and pilot production activities, troubleshooting issues related to product performance.
• Identify and implement process improvements to enhance project delivery, team efficiency, and product quality.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.
• 5+ years of engineering or project management experience in the medical device industry.
• PMP or similar certification preferred.
• Experience with Class II or Class III medical devices preferred.
• Experience in CAD (SolidWorks or equivalent), simulation tools, and PLM systems preferred.
• Experience with capital equipment, disposables, or software-enabled devices preferred.
• Familiarity with rapid prototyping, tolerance analysis, and DFM/DFA preferred.
• Familiarity with project management tools (e.g., MS Project, Smartsheet, JIRA, etc.) preferred.
• Strong understanding of product development lifecycle in a regulated environment preferred.
• Experience with the design and development of complex medical device projects preferred.
• Excellent communication, problem-solving, and interpersonal skills preferred.