Device Engineering Sr. Engineer

About the role

The Sr Engineer role is a cross-discipline execution role within the Design for Robustness framework. The role ensures consistent and structured application of robustness methodologies across mechanical design projects, integrating insights from device performance, sources of variation, load cases, materials, assembly, and manufacturing perspectives.

Responsibilities

• Independently execute tasks within one or more of the Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM.
• Provide technical recommendations to improve design performance, reduce sensitivity to variation, and enhance overall system robustness.
• Collaborate across robustness disciplines to identify risks and mitigations, opportunities and best trade-off solutions.
• Contribute to continuous improvement of robustness disciplines and tools by identifying gaps, proposing improvements, and supporting implementation under governance frameworks.
• Interface effectively with discipline SMEs and incorporating guidance while maintaining ownership of robustness execution within assigned scope.
• Drive structured problem-solving and root cause analysis for design, test, and field performance issues, ensuring robust corrective solutions.
• Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures.
• Apply systems-level thinking to anticipate how design decisions impact downstream manufacturability and performance.

Qualifications

• Doctorate degree
• OR Masters degree and 2 years of Engineering experience
• OR Bachelors degree and 4 years of Engineering experience
• OR Associates degree and 8 years Engineering experience
• OR High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications

• 5+ years of progressive experience as a mechanical engineer.
• 3+ years of experience within development of Medical Devices, ideally Class II and Class III.
• Experience in mechanical engineering disciplines and tools, with hands-on work in at least one Design for Robustness disciplines; Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM, and preferably exposure to several.
• Strong interpersonal skills
• Ability to work within cross-cultural project teams
• Systematic problem solver and solution developer also when presented with conflicting needs and technical issues.
• Experience in drug/device combination product design and development
• Technical understanding of manufacturing processes (injection molding, assembly processes)
• Technical understanding of drawings and design documentation.
• Understand documentation flow for GMP deliverables
• Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
• Fluent in English language