Icon hamburger
Briefcase

Create Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
Missing Translation: eu_consumer_core.job_alert.duplicate_alert
No Thanks
US
What job do you want?

Create Job Alert.

Get similar jobs sent to your email

Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
EU MDR Manufacturing Engineer - Remote at

EU MDR Manufacturing Engineer - Remote

Work From Home Contractor
$42.00 - $52.00 / hour
Apply Now

Create Job Alert.

Get similar jobs sent to your email

Position: EU MDR Manufacturing Engineer II

Location: Remote Role

Duration: 06+ Months Contract (Higher extension possibilities)


Job Description:

• The EU MDR Manufacturing Engineer will perform review/remediation Design Control activities involved in the technical filing of product, under supervision of the EU MDR Engineering Systems Manager. 

• This position will support the EU MDR department by performing tasks that will assure the timely delivery of the documentation, working with cross functional departments. 

• This role will be responsible for the delivery of tasks to ensure conformance to the project plan schedule and for ensuring efficient and effective communication of affected technical file documents for manufacturing to support EU MDR submissions. 

• The SCOPE covers product in the Memphis Orthopedics groups. 

• This covers all manufacturing sites (including 3rd parties) and must be implemented in line with the relevant MDR timelines in order to continue to sell product in Europe. 

• All projects are to be managed using the S&N software V&V, local design control, and change control procedures. The solution is also subject to audit by notified bodies. 


Principal Accountabilities (Major end results the job is expected to achieve): 

• To take ownership of the manufacturing engineering tech document process, ensure it is adhered to and applied effectively, correctly and efficiently 

• Effectively manage 3rd party suppliers (with support of Procurement and Supplier Quality) to deliver expected outcomes (50+ 3rd parties in 5 continents) 

• To deliver the deliverables for MDR Manufacturing prior to MDR timelines associated with the project 

• To take responsibility that change control procedures are followed and that the quality of the work is acceptable to internal and external auditors eg group audit, BSI and FDA 



Job Context / Key Challenges 

• Strong communication skills including technical writing, listening and speaking; ability to influence others communicate effectively with multi-functional teams (internal and external) that assists with driving project completion. 

• High learning agility with the ability to analyse and synthesize data and then present it to senior leaders 

• Independent thinking and the ability to work within a team is required 

• Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving 

• Ability to resolve conflict in a matrix environment is a key requirement of the role. 

• Establish and maintain effective relationships with third party suppliers and internal departments to ensure effective implementation of project delivery. 

• To maintain and develop in-depth knowledge of the EU MDR document compliance requirements and act as the Smith & Nephew Manufacturing process expert for the subject. 

• Documentation to a standard that will be accepted by internal and external auditors. 

• To apply and promote high standards of Occupational Health, Safety and Environmental Compliance in accordance with the Company HSE policy and processes. 

• To comply with the Ethics and Compliance Code of Conduct in all matters pertinent to Smith & Nephew. 


Knowledge and Experience (Knowledge and experience needed for satisfactory performance of the job) 

• A science or engineering based degree, or relevant industry experience 

• Experience of project management within a relevant industry. 

• Experience/knowledge of various Manufacturing processes related to Orthopedic devices. 

• Proven track record of delivery. 

• Knowledge of Verification and Validation activities, PFMEAs, Macro Processing Maps, Detailed Processing Maps. 

• Self- starter, with the ability to work independently 

• Software programs - Microsoft Word, PowerPoint, Excel, and MS Project. 

• Knowledge of applicable specification and regulations standards. 

• Knowledge and understanding of documentation/quality/regulatory processes. 

• Knowledge of change control processes

Recommended skills

Eu Mdr
Manufacturing Engineering
Pmfea
Project Management
Submissions
Validation
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.