Design Assurance Engineer
ArjoHuntleigh AB / Logistikjobb / Malmö
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hela Sverige ArjoHuntleigh is dedicated to increasing the quality and efficiency of care. Our products and solutions reduce unnecessary costs by preventing adverse events that impact on patients and caregivers. With 5.500 dedicated employees worldwide, ArjoHuntleigh is a global group with an annual turnover of SEK 6 870 million, serving the needs of acute and long-term care in more than 100 countries.
The position
The Design Assurance Engineer is responsible for providing support and guidance to new product development teams to assure the quality and reliability of new products through the appropriateness of design inputs, completeness of verification and validation testing, and identification of key quality characteristics for the device. Additionally, this position is responsible for facilitating the risk management process for new products.
Among your main responsibilities and tasks will be:
• Participate in the development of Design inputs; customer requirements/user needs, based on a Voice of Customer as appropriate and engineering requirements. The jobholder will ensure user needs can be validated and engineering requirements can be verified and will make sure that requirements from reliability engineering and regulatory compliance standards are included in Design Inputs (i.e. 60601 etc).
• Ensure adherence to all aspect of the Risk Management Process, including, but not limited to, development of all documentation. This involves research and document historical data (e.g. complaints, CAPAs, Service Data, Repair Data) for similar products/components.
• Be involved in Supply Chain activities (i.e. PPAP, process validation, supplier selection etc)
• Provide assistance to Supply Chain, contract manufacturers and OEM suppliers throughout the early production builds and launch. This involves supporting the effort through documentation and training, as required.
• Review and approve drawing release specifications, as appropriate, and ensure that Critical to Quality characteristics and inspection characteristics are included on specifications/prints.
• Provide support to Manufacturing Engineering to ensure organization readiness for new components and/or assemblies. These activities include ensuring drawings/specifications are clear, availability of correct tools/equipment for inspection/test and qualification of measurement/test methods.
• Be accountable for thorough review and approval of design controls per RACI matrix and for consistency across all documentation, by keeping audit readiness in mind.
• Participate in all phases of product verification, including software validation. This means working with Verification Engineering in preparing protocols/test methodologies, developing test sample sizes, and establishing acceptance criteria as well as reviewing all test data, analysis and final test reports.
• Provide support to Regulatory for submissions and technical files and also be the point of contact for third party standards testing (i.e. IEC 60601, ISO 10993, etc)
• Support Post Market Surveillance for assigned new products.
International travel is estimated to 10% and the location is ArjoHuntleigh's global innovation center in Malmö.
The ideal candidate
As ideal for the position you have a minimum of a Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related engineering together with at least 5-7 years experience from regulated design environments - specifically medical device development, FDA or ISO registered work experience.
Some of your key characteristics include:
• Broad knowledge Risk Management ISO 14971, IEC 60601, Federal Code of Regulation, MDD, Quality Engineering, Product Development and Design Verification engineering.
• Experience in drawing and specification review.
• Experience in good documentation practices.
• Experience with managing testing at external test facilities
• Experience with regulatory audits and knowledge of auditor expectations.
• Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude.
• Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
Application
Welcome with your application no later than 7/1-2015 if you are interested in the position. You are also welcome to call Jeanette Losole +1 (210) 262-9950, Karolina Nilsson at +46 (0)10 335 4749 or Björn Friberg at + 46 (0)10 335 45 69 if you have questions.
Getinge Group is a leading global medical technology company with operations in the areas of surgery, intensive care, infection control, care ergonomics and wound care. The Group is organized into three business areas: Extended Care, Infection Control and Medical Systems, and operates under the ArjoHuntleigh, Getinge and Maquet brands.
We employ more than 15,000 talented employees across the globe who delivers innovative products and solutions that contribute to quality enhancement and cost efficiency within healthcare and the life sciences. At Getinge Group you are involved in the creation of sustainable healthcare for future generations.
Getinge Group is active in over 40 countries and generates sales exceeding SEK 25 billion. We are expanding rapidly and will double in size over the coming years. Join us on this exciting journey!
Publiceringsdatum2014-12-05Arbetstider och omfattningHeltid Tills vidare
ErsättningFast
Så ansöker duSista dag att ansöka är 2015-01-06
Ange följande referens när du ansöker: Design Assurance Engineer
Klicka på denna länk för att göra din ansökanFöretagArjoHuntleigh AB
AdressArjoHuntleigh AB
Hans Michelsensgatan
21120 Malmö
KontorsadressHans Michelsensgatan
Jobbnummer 2091714
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