Senior Mechanical Engineer, Medical

Role Overview

The Senior Mechanical Engineer will have 5+ years of experience in medical devices, product development, mechanical design, and engineering. This role will lead, advise, and assist a team of engineers to execute projects, ensuring on-time submission of deliverables.

• Manage and facilitate client interactions with clear communication as it relates to deliverables, design reviews and deadlines.
• Work independently, as a team leader or as part of a team to create mechanical concepts for overall packaging strategies, mechanisms, and parts while balancing function, appearance, form, and budgetary requirements.
• Provide DFX expertise to ensure designs are optimized.
• Design and develop precision mechanical products utilizing injection molding plastics, machining, casting, laser cutting and welding, extrusion and 3D printing.
• Execute iterative development cycles using rapid prototyping, root cause analysis, tolerance stack analysis, FEA, concept down-selection tools, or other engineering methods.
• Lead and document Design History File development activities including but not limited to Design and Development planning, system requirements, risk management, hazard analysis, xFMEA, design inputs and outputs, test plans, protocols and reports.
• Plan and execute formal verification testing, including test method development, test method validation, data analysis, and design of experiments.
• Work with team members to resolve conflicts among resources and between clients and engineering teams.
• Coordinate priorities and design decisions between interdisciplinary team members including electrical engineers, software engineers, human factors engineers, systems engineers, and industrial designers.
• Operate within a Quality Management System as well as contribute to continuous improvement efforts.
• Remain apprised of the progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions.
• Support project scoping activities to support Business Development and Sales teams.
• Communicate to senior management any significant project risks or deviations from the plans.
• Serve as a mentor for less experienced team members.
• Travel as needed (valid driver’s license and vehicle required).
• Keep all privileged information private and confidential.

• Bachelor’s degree in mechanical engineering or related field.
• Proven experience in one or more of the following industry segments:
  Neurology, Cardiovascular, Orthopedics, Women’s Health, and Diabetes.
• A functional knowledge of FDA design controls 21 CFR Part 820 and recognized standards such as ISO 13485, ISO 14971 and IEC 60601.
• Proficiency in the latest version of Solid Works CAD package.
• Working knowledge of common sterilization methodologies, biocompatibility, sterile packaging, shelf-life, and simulated distribution validation testing.
• 2D drawing creation, GD&T, tolerance analysis.
• Strong teamwork, interpersonal and communication skills, and a demonstrated ability to work at a high level of performance both independently and collaboratively.

The pay range for this role is: 105, USD per year (Wilmington Office)