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Sr. Manager, Mechanical Engineering
Sr. Manager, Mechanical EngineeringOrthAlign Inc. • Irvine, CA, US
Sr. Manager, Mechanical Engineering

Sr. Manager, Mechanical Engineering

OrthAlign Inc. • Irvine, CA, US
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  • [job_card.full_time]
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Job Description

Job Description

Salary : $160,000 / annually

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for aSr. Manager, Mechanical Engineering.

The Sr. Manager, Mechanical Engineering is responsible for managing a team of mechanical engineers and designers and coordinating tasks across multiple medical device projects.

You will :

  • Support the team creation of detailed, complete, and accurate specification to meet system and component level requirements.
  • Define, manage, and communicate comprehensive and accurate project timelines.
  • Define, develop, and communicate testing strategies.
  • Effectively manage design changes including collaborative development of adoptions and justifications where applicable.
  • Support the definition and development of design verification and validation plans, and coordinate and drive timely execution.
  • Lead and support product risk assessments.
  • Drive effective cadence of technical design reviews with required, qualified staff.
  • Provide continual monitoring of projects and direction to the Engineering team.
  • Lead and mentor team of mechanical engineering professionals.
  • Develop work breakdown structures for complex system-level projects and ensure optimal use of staff; manage and respond to resource needs and bottlenecks.
  • Work closely with Program Management / Systems Engineering to ensure technical workstreams are aligned with timelines and issues / blockers are raised and resolved in a timely manner.
  • Identify and develop suppliers. Develop and execute DFM strategies.
  • Possess managerial toughness to ensure staff are executing at a high level.
  • Organize and manage sustaining projects while providing support for new product projects.
  • Manage the model shop. Ensure full capacity utilization and continuous improvement of processes and capabilities.
  • Interface with marketing and sales personnel and collaborate effectively with cross-functional stakeholders.
  • DFM, DFI, and design for reliability expertise.
  • Determine design direction based on results of planned feasibility studies.
  • Dimensioning and tolerancing. Mating part analysis. GD&T including knowledge of ASME and ISO standards,

You need :

  • Master's degree in mechanical engineering with medical device experience.
  • 10+ years of experience in mechanical design of medical device products.
  • Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint).
  • Excellent attention to detail, producing high quality output.
  • Ability to apply sound judgment when making decisions and communicating with peers and management.
  • Extensive experience in the development, manufacturing, and commercialization of medical device products (surgical devices preferred).
  • Strong background navigating ISO 13485 design control requirements of Design Controls.
  • Machine design and machine shop best practices and know-how.
  • Knowledge of and experience with ASME and ISO and key standards for medical device dimensioning, tolerancing, and drafting.
  • Experience leading, mentoring and developing teams.
  • Experience in mechanical and surgical devices required (Orthopedics a plus).
  • Experience with electromechanical products a plus.
  • We offer :

  • Innovative products
  • Awesome benefits
  • Great coworkers
  • An evolving, engaging culture and workplace
  • It is an exciting time atOrthAlign- make your next career move with us!

    Please note that we are unable to provide any type of sponsorship at this time.

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