A major Medical Device client of Real Staffing is seeking a Process/Continuity Engineer to join on a 6 month contract at their site in Danvers, MA.
The Job: Sourcing Continuity Engineer
Top required skills:
1. Experience partnering and collaborating with suppliers
2. Experience with reviewing/preparing test protocols and reports (qualification, validation) for supplier changes and development activities.
3. Strong interpersonal skills to work across multiple functions to resolve issues
* Partner and collaborate with suppliers to ensure their processes are properly characterized, have adequate controls in place, and are properly monitored and reported on per required procedures, contracts, and applicable signed agreements.
* Collect data, and report on key performance indicators for strategic suppliers.
* Lead projects/programs of moderate to high complexity associated with component(s) qualification, quality improvement and cost improvement projects
* Develop a strong relationship with supplier as related to technical issues and qualifications
* Develop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
* Develop a robust risk management evaluation with each supplier regarding impact of processing and equipment changes.
* Review/prepare test protocols and reports (qualification, validation) for assigned change and new tool development activities.
* Provide technical assistance to suppliers/other resources performing qualification/validation testing.
* Develop and implement processes for component qualification that are aligned with stated quality requirements, regulations and guidelines.
* Drive sub-tier supplier requirements and monitoring as defined in the risk management assessments.
* Participate in the audit/assessment of current or future suppliers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements from SME perspective.
* Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component engineers to ensure supplier practices are used across the business.
* Provide statistical support by the creation of supplier related metrics for the purposes of tracking processing performance and identifying opportunities for supplier improvements.
* Provide direction to other staff resources in injection molding to prioritize and execute tasks/responsibilities.
* Support/participate in processes for resolution of technical issues.
* Ability & willingness to travel up to 25%, domestic and internationally
To be considered for this position you must have a Bachelor's Degree in a relevant discipline and a minimum of 2-4 years of relevant experience, or an advanced degree with a minimum of 0-2 years of relevant experience
Nice to Have:
* Polymer science/engineering experience
* Medical device manufacturing and assembly experience
* Polymer and Catheter Assembly process equipment knowledge
* Proven problem solving skills; knowledge of DMAIC is preferred
* Strong project management and leadership skills and experience
* Ability to multi-task and be organized
* Strong interpersonal skills to work across multiple functions to resolve issues
* Strong verbal and written communication skills
* Demonstrated strong technical writing skills
* Basic statistics, including Six Sigma principles
* Minitab for statistical data analysis
* Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
* Development characterization and qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
* Oral, Presentation and Written communication skills
* Minitab, CAD program experience
Sthree US is acting as an Employment Business in relation to this vacancy.