Production Development Engineer II

Job description

Requistion ID : 83678 Wellspect Healthcare is a leading global provider of innovative medical devices that help people suffering from urinary retention or chronic constipation. More than 1,000 employees around the world are dedicated to making a difference to people who need our products and services. Wellspect is one of the worlds’ leading manufacturers of intermittent urinary catheters, with LoFric® as the most known brand. As a help to those with chronic or severe constipation Wellspect has developed what likely is the world’s most advanced irrigation system, Navina™, combining a high degree of user convenience, clinical effectiveness and connectivity into one smart system. Wellspect strives to become climate neutral and leave the smallest possible environmental footprint. The company, with headquarters in Mölndal, Sweden, is present in more than 30 countries, and part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental technologies. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit and for more information. Production Development Engineer - Mechanical Design Engineer Join our Production Development team and continue shaping medical device production of tomorrow. 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: 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 #Wellspect #LI-MT1 Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law. Eligibility: All successful applicants must be eligible to work in the country the position is based. Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to . Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms. Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. 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