Cogmedix

The Laser Engineer will lead and participate in the success of laser and optical systems engineering efforts for Engineering Services projects and Manufacturing.  The Laser Engineer technical communications requirements include but is not limited to customers, suppliers and Cogmedix internal stakeholders and associates. Assuring compliance within Cogmedix Quality Systems, 21 CFR 820.30 and ISO 13485. The Laser Engineer will drive continuous improvement on their individually assigned product accounts in addition to departmental processes and procedures. 

Responsibilities:

  1. Under the direction of the Senior Vice President of Engineering Services and Optical Mechanical Engineering Manager, the Laser Engineer will:
    1. Participate in concept generation and requirements definition/interpretation.
    2. Participate in technology assessments of customers’ lasers and optical systems, 
    3. Assemble, align and evaluate lasers and optical systems performance at the component, subassembly and system levels
    4. Operate and maintain variety of optical, test and analytical instruments.
    5. Develop and execute laser and optical systems component reliability and qualification tests
    6. Analyze and present test data; discuss results with technical staff, external partners, and customers 
    7. Learn and exemplify optics and lasers best practices during execution of project tasks
    8. Provide engineering and technical leadership as a subject matter expert and be part of internal and external engineering teams that must meet changing requirements and diverse advanced technologies to serve our medical customers’ time to market demands, patient safety requirements, and compliance obligations.
    9. Work in a transparent manner, and practice practical laser and optical systems engineering best practices.
    10. With strong collaboration across departments, provide technical leadership to the organization with a focus on design engineering and manufacturing. 
    11. Maintain positive, high performance environment that fosters extraordinary customer satisfaction and associate retention.
    12. Recommend improvements to and maintain compliance to the Cogmedix Quality System, 21 CFR 820.30, and ISO 13485.
    13. Design to meet global product safety standards.
    14. Participate in laser and optical systems engineering execution of multiple complex projects from design, prototype, pilot production and transition to manufacturing.
    15. Practice Best Practices and Policies consistent with company goals and objectives in an open and collaborative manner.
    16. Reinforce and encourage company core values.
    17. Provide professional and technical assistance and guidance to associates and customers.
    18. Support the development of detailed proposals and SOW’s for lasers and optical systems engineering services.
    19. Participate in lasers and optical systems engineering compliant to medical device product safety regulations such as IEC 60601-1 and laser safety regulations such as IEC 60601-2-22 and design controls.
    20. Provide engineering services such as work instruction development, tooling and fixture design.
  1. Develop and lead laser alignment and optics handling excellence training within Cogmedix.
  2. Support DFcx Engineering programs.
  3. Perform other activities as directed.

Essential Requirements:  

  1. Superior customer service attitude.
  2. Excellent teamwork, communication, interpersonal and leadership skills. 
  3. BS Degree in Physics, Optics and/or mechanical engineering or closely related field.  MS preferred.
  4. Minimum of 5 years of experience in laser design, alignment and optics handling required.  Medical device product development preferred.  Other experience may be considered in lieu of the 5 years.
  5. Experience with optical metrology.
  6. Direct experience working within design controls (21 CFR 820.30) processes is preferred. 
  7. Excellent negotiation, written and oral communication skills, including experience presenting to customers and internal senior management. 
  8. Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery. 
  9. Excellent technical, problem solving and analytical abilities.
  10. Strong quality mindset a must. 
  11. Must be flexible, possess strong work ethics and interpersonal communication skills; ability to manage multiple priorities. 
  12. Strong decision making capabilities and capacity to handle confidential information.
  13. Experience in phase gate product development is preferred.
  14. A demonstrated commitment to company values.   
  15. Proficient in Microsoft Office.
  16. Laser and optical design experience is required.
  17. SolidWorks experience is a plus.
  18. ZEMAX and/or TRACEPRO experience is a plus.