Senior Mechanical Engineer

at  Verathon

Company Overview:
Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.
Overview:
The Senior Mechanical Engineer is responsible for designing and developing robust and innovative medical devices and equipment to support the commercialization of company developed products. The responsibilities include cost estimation, design, verification, and validation. Device and equipment design includes active and passive electromechanical structures and mechanisms with various degrees of freedom. Assignments are broad in nature, usually requiring appreciable initiative, originality, ingenuity, and excellent problem-solving skills.

Responsibilities:

• Serve as technical lead and project engineer for major development projects or multiple simultaneous projects.
• Research design options and perform experiments to determine potential design feasibility.
• Develop and test new manufacturing processes.
• Work closely with electrical and software engineers, designing with system-wide perspective.
• Interact with global and internal design and manufacturing resources to design for manufacturability, reliability, and cost-effectiveness.
• Specify and manage tool development.
• Create and release product requirements, design specifications and design descriptions for assigned projects, as required by applicable medical device standards and internal procedures.
• Follow all policies, procedures, and standards for engineering documentation to ensure compliance with corporate document management policy.
• Review product documentation for accuracy including documentation intended for customer use.
• Provide technical leadership and mentorship to the mechanical engineering team.
• Leads designing, prototyping, testing and qualification activities of mechanical designs for high-reliability and high-performance medical devices.
• Assist in project planning and provide technical team leadership in project execution.
• Lead and support risk assessment, design reviews, pre-production, pilot production, testing, and regulatory submission
• Support production activities and resolve issues quickly.
• Evaluate product non-conformances and recommend design modifications.
• Lead the development of intellectual property.
• Guides critical decision-making processes on complex, high-impact projects.

Qualifications:

• Typically requires a minimum of 8+ years of related technical experience.
• Bachelor’s degree in mechanical engineering is required; MS or PhD preferred.
• P.Eng. designation required.
• Excellent knowledge of and ability to use SolidWorks and SolidWorks add-ins.
• Proven history leading all areas of design, prototyping, testing and qualification.
• Strong knowledge of plastic injection mold tool design including insert molding and over-molding
• Proven skills in developing projects in a medical device R&D department.
• Ability to define project goals and delivery dates to meet deadlines in a fast-paced environment.
• Can make independent judgments using sound engineering principles and techniques.
• Ability to write concisely and accurately with meticulous attention to detail and clarity.
• Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment is preferred.0

• Serve as technical lead and project engineer for major development projects or multiple simultaneous projects.
• Research design options and perform experiments to determine potential design feasibility.
• Develop and test new manufacturing processes.
• Work closely with electrical and software engineers, designing with system-wide perspective.
• Interact with global and internal design and manufacturing resources to design for manufacturability, reliability, and cost-effectiveness.
• Specify and manage tool development.
• Create and release product requirements, design specifications and design descriptions for assigned projects, as required by applicable medical device standards and internal procedures.
• Follow all policies, procedures, and standards for engineering documentation to ensure compliance with corporate document management policy.
• Review product documentation for accuracy including documentation intended for customer use.
• Provide technical leadership and mentorship to the mechanical engineering team.
• Leads designing, prototyping, testing and qualification activities of mechanical designs for high-reliability and high-performance medical devices.
• Assist in project planning and provide technical team leadership in project execution.
• Lead and support risk assessment, design reviews, pre-production, pilot production, testing, and regulatory submission
• Support production activities and resolve issues quickly.
• Evaluate product non-conformances and recommend design modifications.
• Lead the development of intellectual property.
• Guides critical decision-making processes on complex, high-impact projects