Product Development Engineer - Basel area

Proclinical has a brilliant opportunity for a Product Development Engineer to be based in Basel on a contract basis. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.

Working in the Product Development team the qualified candidate for this position will support efforts to ensure EU MDR compliance. Must have medical device product development experience and experience with Medical Device Regulations.

Job Responsibilities:

• Review and approval of documentation to support Technical Document to meet MDR requirement
• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements
• Participate in cross functional teams to discuss and revise documents to meet MDR requirements
• Create, review and approve engineering rationales/memos as required
• Ascertain if rationales are required, create or review rationales, approve as required
• Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
• Report task progress and status on a weekly basis.

Skills and Requirements:

• Experience with all the design and development aspects of a series of projects through all phases of the product development process; planning and executing projects or portions of projects from concept through commercialization, and into post-market surveillance.
• This individual will also be involved with the review and revision of design verification and validation documentation and test reports that support regulatory review for US and global registration effort.
• Must be experienced with product design and all components of product design including documentation for design controls and Design History Files.
• Must have a strong compliance background and experience with Medical Device Regulations.
• Candidate must also possess knowledge of applicable ASTM/ISO standards (i.e., biocompatibility standards). Engineer will need to ensure standards are appropriate and review documentation of evidence that the standards are met and documented appropriately.
• This individual should have a demonstrated ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills and interface effectively with project teams, management and surgeons.
• A minimum of 5 years of professional experience in engineering is required (not including co-op, internship and research). Prior experience in Product Development role is required.
• Experience working in Medical Device, Spine or Orthopedic experience is preferred.
• Prior experience working cross functional project teams, bringing products from concept to launch, is preferred.
• Previous experience with remediation efforts to meet EU MDD/MDR preferred
• Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
• Working knowledge of material science and mechanical product knowledge is preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 203 8460 643 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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