OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Mechanical Design Engineer responsible for the development of new instruments and devices, transitioning products from design phase to production, and designing and developing devices adhering to Design Controls and Quality System SOPs. You'll serve as design engineer on cross functional teams providing strong, consistent effective collaboration. We are excited to announce that our office is relocating to Irvine, CA, near the 5 and 133 freeway exchange, in early April.

You will:

• Complete the design and development of new products per company’s design control procedures and QSR requirements in accordance with plans and milestones
• Develop refined, comprehensive and documented understanding of user needs, design requirements, inputs, outputs
• Plan and facilitate testing, executing and documenting product verification and validation testing for compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements and related specifications, in a timely manner
• Ensure device compatibility with product system/platform (mechanical, software, electronics) and that device(s) meet(s) requirements
• Support risk and hazard analyses with required documentation
• Work with MFEs and DQEs to develop and document the manufacturing and inspection procedures and processes for new products in compliance with the company’s quality system and business goals
• Transition product from concept to design phase through V&V to production
• Communicate progress to project leaders in periodic status meetings/reports
• Work closely with suppliers to deliver requested product
• Work closely with Quality, Regulatory, Marketing, Sales and Customer Service to support the product in the field, manage the analysis of all product returned from the field, and design & implement product improvements
• Develop new suppliers, new manufacturing procedures and product enhancements

You need:

• BS degree in Mechanical Engineering, Biomedical Engineering, or equivalent
• 5 years of experience working directly with medical device products, and fluent in CAD software, SolidWorks preferred
• Experience in orthopedic devices/instruments and with electrical assemblies a plus
• Technical and design leadership from design concept to commercial release
• Cadaver lab experience
• Experience working with both contract manufacturers and internal manufacturing facilities
• Full comprehension of dimensioning and tolerancing, GD&T, Mating part analyses, and DFM
• Ability to develop and execute verification, validation and qualification protocols
• Strong Knowledge of FDA, ISO, GMP and design controls with a focus on user needs, design inputs/outputs, V&V and transfer to manufacturing
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint).
• Results-oriented with appropriate urgency
• Ability to work as a collaborative team member as well as independently
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Applies sound judgment when making decisions and communicating with internal and external customers

 We offer:

• Competitive compensation including bonus and equity
• Opportunities for career advancement
• Full benefits package
• An evolving, engaging culture and workplace

It is an exciting time at OrthAlign - make your next career move with us!