Description

You will manage product improvement and infrastructure projects from planning through launch, ensuring delivery meets technical requirements, budget constraints, and Cost Of Goods targets.

Responsibilities

• Develop and manage project objectives, schedules, plans, and budgets.
• Coordinate cross-functional teams, suppliers, vendors, and subcontractors to achieve project milestones.
• Own product specification, verification, validation, and the maintenance of Design History Files and Device Master Records.
• Manage risk by identifying medical device hazards, maintaining Risk Management files, and conducting safety testing per UL, ISO, and IEC 60601 standards.
• Investigate and resolve product issues using DMAIC, FMMEA, Ishikawa, or Fault Tree analysis.

Required Skills

• 7-10 years of project management experience in medical device environments (Class II and Class III).
• 3+ years of experience as a Lead Project Engineer developing complex systems.
• 3+ years of experience as a Systems Engineer focused on requirements development and management.
• Proficiency in DMAIC, FMEA, and Ishikawa problem-solving methodologies.
• Expertise in medical device design documentation and FDA design controls.
• Ability to manage projects within strict budget and schedule constraints.
• Strong understanding of UL, ISO, and IEC 60601 standards.
• Bachelor's Degree (B.S.) in Mechanical, Electrical, or Systems Engineering.

Preferred Skills

• Experience maintaining compliance with engineering SOPs and international regulatory requirements.

Key Skills

Education

Bachelor's Degree