OrthAlign, Inc. · 1 day ago
Sr. Manager, Mechanical Engineering
Irvine, California, United States
Full-time
Onsite
Director/Executive
$160K/yr - $160K/yr
10+ years expOrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr. Manager, Mechanical Engineering. The Sr. Manager will manage a team of mechanical engineers and designers while coordinating tasks across multiple medical device projects.
BiotechnologyHealth CareHealth DiagnosticsMedicalMedical DeviceNavigation
No H1B
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
Qualification
Required
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
Benefits
Innovative products
Awesome benefits
Great coworkers
An evolving, engaging culture and workplace
Company
OrthAlign, Inc.
Our Mission: Driven by the belief that everyone deserves exceptional healthcare, we are committed to making empowering technologies accessible to all.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$55.81MKey Investors
RC CapitalCalifornia Technology Ventures
2020-09-02Series Unknown· $11.23M
2019-12-30Series Unknown· $3.21M
2017-09-27Series D· $10M
Leadership Team
Eric B. Timko
Chairman and CEO
Mike Bushlack
Chief Financial Officer
Recent News
Company data provided by crunchbase