Director, Mechanical Engineering

at Mesa Biotech, Inc.
Location San Diego
Date Posted April 8, 2021
Category Engineering
Job Type Not Specified

Description

SUMMARY:

The Director, Mechanical Engineering is responsible for the management of all engineering projects as well as the operations and direction of the Engineering department. Responsible for all engineering aspects of product development, including requirements, design, V&V, risk assessment, and design transfer. The Director, Mechanical Engineering is additionally responsible for the daily operations of the Engineering Department, including the engineering facility and equipment along with monitoring projects, assigning, and tracking tasks, and monitoring the performance and growth of team members.

RESPONSIBILITIES:

  • Engineering Oversight

o Create product requirements and specifications along with project timelines

o Create design verification and validation plans, and coordinate their execution

o Conduct product risk assessments, lead design reviews and team meetings

o Provide continual monitoring of projects and direction to the Engineering team

  • Design

o Brainstorming and evaluation of conceptual product designs,

o Determine design direction based on results of planned feasibility studies

o Provide mechanical design input at all levels

  • Operations

o Provide facility planning support for the organization, procurement of resources needed to support engineering efforts (equipment, computers, software, etc.)

o Administration of Solid Works CAD database & environment

o Assist in the creation of SOPs to streamline internal processes

  • Team Management

o Resource planning

o Delegation of tasks and monitoring of performance, set goals for team members, provide growth paths for team members, conflict resolution

KNOWLEDGE AND SKILL:

  • Extensive experience in the development, manufacturing, and commercialization of point-of-care, in-vitro diagnostic platforms
  • Experience with the development of point-of-care, in-vitro diagnostic platforms that address ISO 13485 design control requirements
  • Proficient with Solid Works 3D design

EDUCATION/EXPERIENCE REQUIRED:

  • Bachelor's degree in a relevant engineering discipline
  • 10+ years of engineering experience required
  • Proven track record leading engineering teams in IVD/Medical Device or biotechnology industry
  • Design of in-vitro diagnostic instruments and disposable cartridges, ideally in point-of-care settings such as physician offices
  • Commercialization of at least two point-of-care, in-vitro diagnostic platforms

PHYSICAL DEMANDS:

  • Ability to work long hours and execute under pressure with short turnaround times
  • Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.
  • Available nights, weekends, and holidays when needed
  • Ability to lift up to 30lbs

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