Senior Design Control Engineer in Medical Device
Dfind Science & Engineering AB / Kemiingenjörsjobb / Lund
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Come and join BONESUPPORT in a new position as Senior Design Control Engineer! Here is a chance to contribute with your experience in medical device and technical documentations in an innovative company with exciting products - where you will take lead on the Product Lifecycle.
Main duties:
BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. To further strengthen the company, BONESUPPORT is now looking for a communicative Senior Design Control Engineer who has an eye for details and how they contribute to the bigger picture as well as strives to deliver results.
This is a new position and it entails leading the Product Lifecycle management of BONESUPPORT's products, where your focus will be on the process of design control. You will be responsible for that the products are in compliance with the regulatory requirements throughout the life cycle of the products. In this role you will up-date, review and establish engineering documents and Standard Operation Procedures according to the regulatory requirements, lead risk assessments (FMECA) with multi-functional teams and be in charge of verification and validations as well as CAPA investigations. With your experience and knowledge, you will have the chance to take the company to the next level when it comes to work with design control and regulatory compliance. You will be part of the R&D team and collaborate closely with Quality, Regulatory and Manufacturing as well as external partners. As senior design control engineer you will report to the VP R&D.
For the right candidate this is a great opportunity to take on stimulating challenges. BONESUPPORT offers a position in an expanding company in an exciting phase where you can make the difference.
Qualifications:
We think you have a technical academic background on a Master level and at least five years of working experience within medical devices and design control. You have good understanding of ISO 13485 and Design control process. You have experience of writing design verification and validation plans and performing CAPA investigations. You have experience of project management and have proficient knowledge in the English language.
It will be seen as a merit if you have knowledge and experience in class III implant products. It is also a merit if you have:
• Knowledge in the Medical Device Regulation (MDR 2017/745)
• Biological evaluation competence
• Usability/Human Factor competence
• Sterilization processes competence
• Experience from pharma industry (Quality & Regulatory aspects)
You find it inspiring to work with people and you naturally take initiatives, solves problems which occurs and strives to deliver results. You prefer to work in a structured way, and have an eye for details and a holistic view. In addition, we believe you are a self-motivated person with the ability to plan and execute effectively and efficiently and with high quality. To be successful you need to be communicative and responsive with a distinct and transparent communication style. We think that you enjoy creating structure and ways to move things forward. We place great emphasis on personal qualities for this role.
Company: BONESUPPORT AB
Location: Lund
Job Type: Permanent position
Last day for applications: 2019.04.15
More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098. Please send your application via
https://www.dfind.se/science-engineering/We look forward to your application!
Description of the organization:
BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient's own bone and have the capability of eluting drugs. BONESUPPORT's bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver and a Premarket approval filing with the FDA (USA) for its gentamicin eluting product is planned in 2020. The company is based in Lund, Sweden, and the net sales amounted to SEK 97 million in 2018.
Please visit
www.bonesupport.com for more information.
BONESUPPORTTM and CERAMENT® are registered trademarks.
Search words: Design control, medical device, ISO 13485, design control, engineer, class III, implant products, design verification, validation plan, CAPA, project management, product development, MDR 2017/745, Usability, Human factor, Product lifecycle management, Lund
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-03-26ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-04-15
Ange följande referens när du ansöker: 201208442
Klicka på denna länk för att göra din ansökanKontaktCamilla Wern 0733-436098
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Styrmansgatan 2
22363 MALMÖ
KontorsadressStyrmansgatan 2, 21118 MALMÖ
Jobbnummer 4691957
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