Senior Mechanical Engineer

• Quickly understand novel technologies and engage with moving them forward towards a product.
• Apply critical thinking and analytical skills to determine mechanical specifications for the medical device    
• Design, develop, and implement highly robust mechanical parts and assemblies, starting with building a proof-of-concept prototype followed by the design and implementation of a final production quality medical device.
• Participate in technical design and design review meetings to discuss challenges related to the medical device.
• Work closely with electrical and firmware engineers to solve cross-functional design challenges.
• Create and maintain documentation packages suitable for manufacturing transfer and regulatory submission.
• Support sustaining engineering activities for released and legacy products, including root cause investigation, design updates, documentation changes, and field issue resolution.
• Drive continuous improvement and cost optimization (VAVE) initiatives to enhance product performance, manufacturability, and cost efficiency
• Support design changes and engineering change orders (ECOs), ensuring proper documentation, traceability, and compliance with design control processes
• Interface with Business Development to transfer new activities into the company.
• Manage a limited number of concurrent projects primarily of a mechanical scope in a team consisting of 4 - 6 engineers from multiple disciplines.
• Prepare project reports and other programs or technical documentation.
• Provide senior technical leadership and mentoring to the Mechanical Team members.

• Bachelor’s Degree in Mechanical Engineering. Master’s Degree in Mechanical Engineering (preferable)
• 10+ years of industry experience in design, development and testing of mechanical systems.
• Ability to generate mechanical architecture and componentry concepts for complex mechanical systems
• Intermediate to advanced proficiency in CAD modelling SW.
  • Proficiency with advanced part modelling, surface modelling and parametric feature modelling is preferred.
• Utilize and maintain SolidWorks PDM for version control, design release, and documentation traceability (experience preferred).
• Ability to generate, dimension, and tolerance engineering drawing packages for assemblies of moderate to high complexity.
  • Understands GD&T and tolerance stack-ups.
• Ability to lead mechanical hazard analysis, product, and hardware FMEA processes.
• Ability to generate design input requirements for complex mechanical systems and components.
• Ability to interpret and design for compliance with medical / mechanical safety standards (IEC 60601-1).
• Ability to conduct biocompatibility analyses and design for compliance with ISO 10993-1 preferred.
• Ability to select appropriate sterilization processes and analyze material effects preferred.
• Experience with 3D printing and / or model making for usability testing.
• Machine shop experience to support rapid prototyping, fixture design, and hands-on debugging of mechanical systems
• Experience with design for manufacturing, assembly, and cost; manufacturing methods and production processes.
• Experience with static structural finite element analysis (FEA or FEM).
  • Experience with CFD for simple fluidic systems is preferred.
  • Experience with heat transfer and fluid flow analysis is preferred.
• Experience working in a safety-related quality process is preferred. 

• Ability to interact effectively with clients.
• Excellent critical thinking and analytical skills.
• High level of initiative with ability to self-manage.
• Strong written and verbal communication skills as well as reporting and presentational skills.
• Investigate clinical requirements.
• Regulatory agency experience including UL, CE and FDA approval processes preferred.

• Comprehensive benefits package, including health, vision, and dental insurance.  

• Generous Paid Time Off.  

• Company retirement plan with matching.  

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