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Staff Mechanical ENGINEER

Position Summary

The Staff Mechanical Engineer will lead the mechanical engineering development, including device architecture, requirement development, detail design development, test plan development and execution, as well as transfer into full production release.  This role will collaborate closely with cross-functional team members in Software/Firmware, Electrical/Systems, Technology, Pharma, Quality, Regulatory, Operations and Program Management to develop and implement products from concept to production.  The Staff Mechanical Engineer will also work closely with other internal partners and oversee external partners, including contractors, consultants and contract manufacturers. In addition, the Staff  Mechanical Engineer will work with the cross functional team ensure product features achieve cost and schedule goals and meet applicable regulatory requirements and standards.  The ideal candidate should have expertise in the use of state-of-the-art CAD and analysis tools to create mechanical designs, primarily consisting of injection-molded plastic and formed metal components and assemblies for high-volume production.

Individual

An enthusiastic individual with attention to detail.  Must be able to work effectively in an entrepreneurial, informal medical drug/device developmental company.  This individual must be able to function as a hands-on team member and be a quick-learner and adapt to a fast-pace moving environment.  They must be able to work very efficiently, communicate well and establish strong relationships with multi-functional areas.

Main Responsibilities

  • Lead the mechanical engineering development with both internal & external team members

  • Develop mechanical product architectures and layouts for new generation products that reflect the product concept’s form and functional requirements

  • Lead the overall design, analysis, documentation and functional validation of mechanical components and assemblies

  • Ensure adherence to product development processes and safety and essential performance requirements per Chrono internal procedures, ISO13485 and other applicable regulatory requirements

  • Lead the mechanical engineering characterization and verification testing to validate the robustness and proper performance of new products

  • Collaborate with internal and external teams to ensure the successful design and development of new products

  • Support the development of mechanical tooling and production part qualification (i.e. first-article inspections, manufacturing process capabilities (Cp/Cpk), measurement gage repeatability and reproducibility (GR&R), material certifications, etc.)

  • Supervise and provide direction to engineers and technicians

  • Assist in the product investigations, audits and provide input on mechanical suppliers and external partners

  • Develop and protect company intellectual property by submitting patent applications

Job Requirements

Education:

  • BS degree and/or MS preferred in Mechanical Engineering or equivalent major

Experience:

  • 10+ years of relevant experience in mechanical and/or product design development

  • 2+ years of experience leading teams developing complex and innovative mechanical products; wearable experience preferred

  • 5+ years of experience in medical product development and design control

Expertise:

  • Proven track record of developing challenging and innovative consumer electronics products and bringing the products into mass production; preferably in handheld, mobile and wireless devices

  • Hands-on experience working on innovative first generation products

  • Hands-on experience designing complicated parts, mechanisms and assemblies for manufacture with Pro/Engineer or Solidworks CAD tools

  • Thorough knowledge of geometric dimensioning and tolerancing

  • Experience with overseas partners and manufacturing suppliers

  • Working knowledge of mechanical tooling and production part qualification

  • Experience using laboratory equipment such as machining equipment, 3-D printers, adhesive and thermal bonding a plus

  • Working knowledge of mechanical (FEA) and fluidic simulation tools preferred

  • Work collaboratively in multidisciplinary and cross functional teams

  • Able to work independently with minimal supervision and project manage their own investigations

  • Experience working in a fast paced “startup type” environment

  • Results and deadline driven

  • Start‐up company experience preferred

Travel Requirement:

  • Ability to travel (domestic and internationally)

Equipment Used:  

  • Personal computers

 

APPLICATION FORM

Interested in the Staff Mechanical Engineer role? Please submit the following application form.

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