Summary of the Position:

The Product Support Engineering team is responsible for sustaining activities that support products in the field. This team is an integral part of the R&D Surgical Instrumentation organization and acts as a liaison between several cross-functional teams, including Design Control, MTO, Service, Regulatory Affairs, Clinical, Quality, and Commercial.

JOB FUNCTIONS

Essential Functions

Duties are listed in order of greatest importance.  Other responsibilities may be assigned. 

Technical Guidance: Provide technical advice and recommendations to influence internal and external stakeholders. Change Management: Review change plans and notices, ensuring proper implementation of product changes. Product Lifecycle Support: Apply engineering principles to the research and development of medical devices/technology and provide expertise to support development. Product Compliance: Ensure continuity of products and processes by assessing feasibility, research, design, and development. Maintain compliance with customer and non-customer requirements throughout the lifecycle, including transfer to production. Analytical Problem Solving: Utilize intermediate-level analytical techniques and previous experience to adapt or improve existing approaches. Engineering Direction: Provide general engineering direction, developing solutions by coordinating multiple resources to solve complex problems. Regulatory Compliance: Ensure adherence to regulatory, statutory, and legislative requirements for all project work. Autonomy & Decision Making: While generally following a specified course of action, the role allows autonomy to propose alternatives when necessary. Cross-Functional Awareness: Demonstrate an understanding of the broader business context, including external environmental factors that impact the role.

QUALIFICATIONS

Minimum Requirement

• Bachelor’s degree in Electrical, Mechanical Engineering, or related field

• Minimum of 5 years of experience in Medical Devices product development and design control processes.

• Preferred Experience: +2 years Proficiency with Polarion or similar requirements management software tools and PLM tools e.g. Windchill or Teamcenter.

• Strong understanding of systems engineering and modeling principles and practices

• Experience in ophthalmology-related surgical medical devices (preferred)

• Strong problem-solving and analytical skills

• Ability to collaborate across cross-functional teams and manage complex tasks

• Familiarity with medical device development processes and regulatory requirements is preferred

Knowledge, Skills and Abilities

• Strong Business awareness

• Successful experience working cross-functionally, in matrix organizations and in global teams

• Strong “Collaborative Team player”

• Problem Solving

• Strategic Agility

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