Mechanical Product Development Engineer in Solothu
Jocelyn Blackham is recruiting for a Mechanical Product Development Engineer to join a leading medical device company at their site based in Oberdorf on a contract basis for 12 months, with the possibility of extension.
The main purpose of the role will be to:
- Review and approve of documentation to support Technical Document to meet MDR requirements. Documents to include (not limited to) Risk Management (design and process), validation, product drawings, performance testing, trace matrix, material specifications, biocompatibility reports, CER (Clinical Evaluation Report), IFUs, surgical technique, manufacturing process information.
- Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MD requirements.
- Create, review and approve engineering rationales/memos as required.
- Independently assess documentation to determine if it meets MDD/MDR requirements (assess gaps), determine best method to meet requirements and execute the plan.
- 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.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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.
- Knowledge of product development documentation requirements and the manufacture of medical instruments and implants to meet the needs of surgeons & patients.
- Must be experienced with product design and all components of product design including documentation for design controls and Design History Files.
- A minimum of a Bachelor's of Science degree in Mechanical Engineering, or other technical discipline is required. An Advanced Degree is preferred.
- Knowledge of CAD software is preferred; Unigraphics/NX is preferred.
- Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
- Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required.
This is an excellent opportunity to join a global medical device company.
For more information or to apply for this position, please contact Jocelyn Blackham on +41 (0) 417276793 or email firstname.lastname@example.org. Please quote reference QLS43692 in all correspondence.