Sr. Principal Mechanical Design Engineer

Primary Responsibilities

• Cross-functional collaboration with other stakeholders including program managers, manufacturing and quality.
• Incorporate risk-based decision-making into the design process.
• Apply DRM methodologies to all aspects of the design/development process.
• Ensure on-time completion of Design Control deliverables.
• Translate VoX feedback into product requirements.
• Design, develop, analyze, troubleshoot, and provide technical support during product development and manufacturing.
• Design studies to investigate root cause or identify process parameters.
• Perform hands-on root cause analysis on the manufacturing floor, leveraging direct observation of physical processes and sample evaluations to identify and resolve technical issues related to design.
• Lead activities to support product development, improvements to existing products and pre-clinical studies.
• Define and perform verification and validation activities ensuring products meet user needs and intended use.
• Lead the investigation and evaluation of existing technologies.
• Guide the conceptualization of new methodologies, materials, machines, or processes related to existing product manufacturing.
• Coordinate activities with outside suppliers and consultants to ensure timely delivery.
• Write engineering reports and create presentations as required to document and communicate results.
• Collaborate with peers to lead and manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Mentor and guide junior level engineers, delegating and reviewing work.
• Work will be performed in R&D laboratories and in manufacturing facilities.
• Travel to suppliers as well as design and manufacturing sites as required.

Required Qualifications

• Bachelor's degree and minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years relevant experience OR PhD with 6 years relevant experience.
• Experience in complex mechanical system design & product risk management.

Preferred Qualifications

• Experience in the medical device industry & high volume manufacturing.
• Issue investigation and CAPAs.
• Experience in 3D modelling, finite element analysis, and statistical design analysis.
• Process and test method development & validation.
• DRM Greenbelt or above.
• Team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with all organizational levels.
• Hands-on mentality.
• Excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit.
• Ability to apply statistical methods and science-based decisions to design experiments and implement improvements.
• Demonstrated ability to deliver quality technical work within project schedules and timelines.
• Ability to work in a fast-paced, deadline driven environment.