Senior Mechanical Engineer, Process Development

Process Development Engineer

About the role: As part of R&D Infusion Care, the role of the Process Development Engineer is to develop new high quality medical devices fit for cost-efficient high-volume manufacturing for the Infusion Care division. This is done through cross functional interaction in projects by influencing design and manufacturing methods in the early design phases. Through application of Design for Manufacturing, prototyping, and successive application of testing and predictive engineering methods, the Process Development Engineer establishes robust and feasible device designs for assembly. The Process Development Engineer is not responsible for design verification or validation but is responsible for developing robust manufacturing methods that can be verified or validated. The team is also responsible for development of prototype equipment and machinery as well as engineering tests.

Your key duties and responsibilities:

• Lead the development of manufacturing processes both in relation to ongoing new product development projects and as independent manufacturing and technology enhancement initiatives for future implementation.
• Apply structured DfM analysis on selected product concepts in projects and clearly flag designs problematic to effective high-volume manufacturing and communicate manufacturing risks.
• Apply Design for Six Sigma to secure a data-driven base for decision making, to systematically determine process windows and process parameters.
• Coordinate and drive production of prototypes in close liaison with the projects, process development, and cross functional colleagues.
• Perform manufacturing tests, design of new jigs, fixtures, and test rigs, identify and communicate with external suppliers of services, technologies, materials, and manufacturing equipment.
• Produce a thorough and structured documentation package that conforms with regulatory requirements and good documentation practice, securing a smooth development process and efficient hand over to the Advanced Operations department.
• Liaise with the Advanced Operations and Operations organization to use knowledge from manufacturing to select processes and map process related problems which may be solved in future manufacturing.
• Participate in project meetings and contribute to the efficient flow of information, clear communication, and proactive involvement of relevant stakeholders.

Skills & Experience:

• Product Development experience
• Understanding Manufacturing Processes
• Predictive Engineering / Design for Six Sigma
• Understanding of ISO 13485
• Strong technical and mechanical understanding
• CAD modelling and 2D drawing documentation
• Technical writing / documentation experience
• Structured work
• Proactiveness
• Independent work
• Critical reflection
• Creativity
• General IT understanding
• Taking lead and ownership

Qualifications/Education:

• Mechanical Engineer (BSc, BEng, Msc, PhD) or equivalent education or experience
• Manufacturing Engineer (BSc, BEng, Msc, PhD) or equivalent education or experience

Travel Requirements:

• Position may involve travel up to 14 days per year. Some trips may include overnight travel.

Working Conditions:

• This role may be based in Osted with a hybrid working structure.

Ready to join us?

At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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