Senior Device Engineer

The Role

Works as a device engineering team lead or member/lead of cross-functional teams, as well as independent contributor throughout the Combination Product Life Cycle process. Leads or participates in cross-functional teams for design changes, design transfer activities, continuous improvement projects, investigations, risk assessments and protocol execution. Responsible for device life cycle management of on-market combination products and implementation of new products.

Responsibilities

• Leads or participates in design control, change management and risk management activities related to the combination device, design and manufacturing process ensuring compliance to all applicable regulations including FDA Regulation and Guidance for Combination Products
• Performs or oversees biomedical/mechanical engineering design and development work, including design changes and product improvements, Geometric Design and Tolerancing, drawings, tolerance stacks, risk analyses, and engineering analyses
• Establishes or reviews/approves specifications and inspection requirements for components, products, and processes
• Develops prototypes of design concepts for engineering testing and evaluation
• Generates or reviews/approves SOPs, test protocols, engineering test reports and provides laboratory oversight as needed
• Responsible for adhering to design controls and documenting all product development work and updates in a Design History File
• Develops test methods, fixtures, gages, challenge samples, limit samples, simulation devices, and engineering prototypes of design concepts
• Develops or collaborates on and adheres to project plans, timelines, and budgets
• Liaison with internal production sites, quality, regulatory R&D, and Tech Transfer/Launch Teams
• Establish and maintain relationships with production sites and key stakeholders
• Technical oversight of other engineers
• May require management of cross-functional teams and indirect reports
• Reports and escalates to leadership as appropriate
• May provide training for new hires or contractors and may oversee work conducted by contractors or lab technicians
• Other duties as assigned

Qualifications

• Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field
• B.S. Degree in Engineering discipline with 7 - 9 years experience
• M.S. Degree in Engineering discipline with 5 - 7 years experience
• Ph.D. in Engineering discipline with 3 - 5 years experience (Biomedical Engineering or Mechanical Engineering preferred)