Sr. Manager, Mechanical Engineering

OrthAlign Inc.•Irvine, CA

1d•$160,000•Onsite

About The Position

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr. 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.

Requirements

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).

Nice To Haves

Experience with electromechanical products a plus.

Responsibilities

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