Production Development Engineer II

Production Development Engineer - Mechanical Design Engineer

Join our Production Development team and continue shaping medical device production of tomorrow.

About the position

Wellspect is continuing to step up the pace in product and production development. We are now offering a position as a Production Development Engineer with focus on Mechanical Design.

At Wellspect, we are proud to have an in-house, highly automated medical device production with interconnected chemical processes, multiple transport systems and packaging machines. We have strict requirements on material traceability and in-line quality control; an area where we apply Big Data principles and develop machine learning. As a Production Development Engineer, you will play a key role in the development and implementation of new and improved production processes as well as ensuring compliance with existing production equipment, with a strong focus on mechanical design.

Your key accountabilities are:

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• Lead or participate in equipment investment projects all the way from concept, via risk- and requirements handling, testing and validation to commissioning and handover.
• Participate in cross-functional project teams, where you will collaborate with both external equipment suppliers and internal stakeholders/departments to find efficient production solutions with Design for Manufacturing as a guiding principle.
• Manage and participate hands-on in installation, start-up/commissioning, testing/verification activities in our cleanroom production in Mölndal.
• Lead or participate in improvement projects both related to ongoing production but also to the ways of working within production development.
• Develop documentation in compliance with Wellspect’s quality management system built on regulatory requirements from European medical device and FDA quality systems regulations.
• Establish and maintain working relationships with suppliers including evaluations and supplier visits.
• Perform mechanical design and create 2D/3D drawings and participate during building of custom designed equipment.

Who you are

You are a positive and driven team player with strong communication skills. You enjoy collaborating and are motivated by working together with highly skilled and committed colleagues. You are open to challenges and appreciate a role where your contribution makes a real difference every day.

We believe you have

• An academic background, preferably in mechanical engineering or equivalent with experience from production development
• Experience of mechanical design and building custom design equipment
• Strong knowledge of mechanical engineering principles, materials science, and manufacturing processes

• CAD Software Skills: Proficiency in CAD software, AutoCAD Inventor

• Knowledge of automated manufacturing process development, preferably from food/life science or other regulated industry
• Some project management experience
• Experience working with technical specifications and external equipment suppliers
• Knowledge of Lean production and Design for Manufacturing principles
• Experience from qualification/testing/process validation, preferably within life science or other regulated industry
• An interest in and understanding of automation technology including Industry 4.0 principles
• Some experience with data collection and predictive analysis in a production environment
• Documentation and communication skills, in English as well as in Swedish

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