JOB PURPOSE
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
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 8 years of experience in Medical Devices product development and design control processes.
Preferred Experience: +4 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 task
Familiarity with medical device development processes and regulatory requirements is preferred
Managerial experience with a proven ability to lead teams and projects
Knowledge, Skills and Abilities
Strong leadership experience
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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