Senior Engineer I, Device Development

We are seeking a Senior Engineer I, Device Development to support the development of combination products. The candidate will act as the technical SME/project engineer and be accountable for key technical design and development deliverables.

Requirements

• 6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries or related experience
• Experience with developing products or implementing product changes through a structured, phase-gated, product development process
• Demonstrated experience with all phases of the Design Control process
• Demonstrated experience in a technical, product development role on a cross-functional team, leadership role preferred
• Understanding of medical device product development risk management methodologies
• Possesses expertise in statistical analysis, analytical tools, benchtop testing, and experience in root cause analysis/investigation
• Strong team building and collaboration skills across the organization
• Knowledge of performance and regulatory compliance requirements of medical device and combination products

Benefits

• Qualified retirement program
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage