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 Mechanical Engineer is responsible for interacting with design and manufacturing resources to create product enhancements for improved manufacturability, reliability, and cost effectiveness.

Responsibilities:

• Leads sustaining projects from start to finish.
• Coordinates activities on sustaining projects across multiple functional domains.
• Leads in designing, prototyping, testing and qualification of mechanical designs for high-reliability and high-performance medical devices.
• Leads root cause investigations of manufacturing and design related failures and recommend solutions.
• Support production activities, resolving technical issues quickly and effectively.
• Evaluate product non-conformances and recommend design modifications.
• Develop and test new manufacturing processes.
• Review vendor’s process validation plans/protocols.
• Creating test plans to verify design solutions.
• Assess risks for design solutions to technical problems and update risk documentation.
• Work closely with electrical and software engineers, designing with system-wide perspective.
• Specify and manage tool development.
• Follow all policies, procedures and standards for engineering documentation to ensure compliance with corporate document management policy.

Qualifications:

• Bachelor and / or graduate degree in Mechanical Engineering.
• 8+ years of technical product or mechanical device design and manufacturing.
• P.Eng from the EGBC preferred; ability and willingness to obtain a P.Eng license required*
• Proven background of reviewing or preparing process validations.
• Strong knowledge of SolidWorks and SolidWorks add-ins.
• Proficient at statistical techniques, preferably using Minitab.
• Experience working with vendors to complete product changes and qualifications.
• A history of accurately identifying and documenting root cause using formal root cause identification techniques.
• Experience in technical team-focused workplace.
• Ability to make independent judgments using sound engineering principles and techniques.
• Proficient in writing 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.
• For applicants without an Engineer in Training or a Professional Engineer license, an alternative title will be used until a license is obtained. Verathon is proud to provide job-related professional growth and development of employees, including reimbursements for expenses incurred in joining the EGBC.

• Leads sustaining projects from start to finish.
• Coordinates activities on sustaining projects across multiple functional domains.
• Leads in designing, prototyping, testing and qualification of mechanical designs for high-reliability and high-performance medical devices.
• Leads root cause investigations of manufacturing and design related failures and recommend solutions.
• Support production activities, resolving technical issues quickly and effectively.
• Evaluate product non-conformances and recommend design modifications.
• Develop and test new manufacturing processes.
• Review vendor’s process validation plans/protocols.
• Creating test plans to verify design solutions.
• Assess risks for design solutions to technical problems and update risk documentation.
• Work closely with electrical and software engineers, designing with system-wide perspective.
• Specify and manage tool development.
• Follow all policies, procedures and standards for engineering documentation to ensure compliance with corporate document management policy