Sr Manufacturing Engineer

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr Manufacturing Engineer responsible for assisting Engineering, Quality, and Operations with product sourcing, supplier identification, qualification and management, manufacturing and assembly systems, processes and general development, and maintenance of OrthAlign’s supply chain.  Oversees internal company manufacturing processes, works with Engineering and RA/QA to develop, qualify, and maintain internal manufacturing systems, including “make vs. buy” decisions.  Assists Supply Chain Manager with supplier issues.  Partners with design engineering to ensure DFM considerations for new products.  Partners with suppliers to ensure manufacturing processes meet delivery timelines, and cost and quality improvement objectives.  Lead design transfer to manufacturing. We are excited to be working together back in the office where we can collaborate more effectively and freely!  This is a hands-on role with work performed in the office vs. remotely.

You will:

• Support Supply Chain with supplier sourcing requirements, including locating, qualifying, and managing the company's ongoing supply chain relationships.
• Have primary responsibility for Design for Manufacturability and working with internal customers &suppliers to identify and implement revisions and improvements to designs for COGS and manufacturability benefits.
• Provide engineering support for assigned product lines (NCMR, validations, and process improvements). Provide direction for assigned product lines for process improvements and overall line support.
• Have primary responsibility for owning and improving existing MPs (manufacturing procedures) utilized in the production of company products.  Work with Engineering team to establish & qualify new MPs for new product designs.
• Assist RA/QA and R&D as required to investigate customer product complaints or product performance issues, especially if the failures relate to supply chain issues.  Assist in any additional operations and quality activities as assigned.

You need:

• At least 5 years of experience in direct medical device development in manufacturing engineering
  
• BS/BA degree in Engineering
  
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
• Excellent written and verbal communication skills
• Ability to work as a collaborative team member as well as independently
• Excellent attention to detail, producing high quality output
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Sound judgment when making decisions and communicating with peers and management
  
• ŸExperience with medical device products and manufacturing operations, preferably including knowledge of regulations governing the manufacturing of medical device products (ISO 13485)
• Knowledge of equipment and tooling design / validation
• Understanding of design and process risk analysis
• Ability to learn, apply, and communicate technical product information / requirements
• Experience working in a start-up or small medical device company environment preferred
• High energy, passion, sense of urgency, and a determination for success of the team and our customers
• Knowledge of machined and molded components and fabrication methods for electromechanical devices and surgical instruments
• Established RA/QA knowledge within medical device organizations, including the ability to interact with various regulatory / notified bodies (e.g., U.S. FDA)
  

 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!