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Job Details

Senior Engineer Design Assurance

Company name
Smiths Medical

Location
Plymouth, MA

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Profile

Closing On: 31\/05\/2018 Job Description Provide functional leadership to project team members with a high level of personal accountability, employee engagement, and value-added support to cross-functional partners. Opportunity to lead design assurance initiatives with new product introductions and marketed product advancements within Smiths growing hospital and ambulatory infusion business unit. Duties and Responsibilities Opportunity to lead design assurance initiatives with new product introductions and marketed product advancements within Smiths growing hospital and ambulatory infusion business unit. Ensure Smiths Medical new product introductions and product change activities are in compliance with applicable FDA\/EU regulatory requirements and Smiths Medical Policies and Procedures. Support rigorous planning activities in relation to design control and risk management deliverables. Assure organizational understanding and compliance of design quality with regard to risk management requirements and international standards. Manage deliverables from the design process including DHF and project files. Collaborate with design and test engineers in the development of verification and validation protocols and reports. Participate on design teams to assure customer product requirements and quality requirements are documented and addressed. Ensure disciplined execution of business unit product changes. Ensure conformance to industry related regulations within the framework of Smiths Medical product and sustaining development processes. Support deployment of internal development procedures including Design Control, Risk Management, Post Market Surveillance, and Statistical Techniques to the product development teams. Interact and form constructive working relationships with all levels of leadership within Global Quality and Regulatory (GQR), Global Product Management (GPM), R&D, Advanced Manufacturing Engineering (AME), Systems Engineering, Sourcing, Operations, and Service\/Repair. Other duties as assigned with or without accommodation. This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site). Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Required Skills and Experience Technical Knowledge and Skills: 4 year degree in engineering or associated scientific discipline. 3 - 6 years\u2019 experience in Quality or Design Engineering position. Complete understanding and wide application of technical principles, theories, and concepts in the engineering field. Proficient at problem solving and analytical techniques such as Is\/Is Not Matrix, Fish Bone Diagram, Concentration Diagrams, Contradiction Matrix and Design of Experiments (DoE). Proficient in use of statistical analysis and associated tools (e.g. Tableau, Minitab, Statistica). Strong comprehension and demonstrated ability to apply critical regulatory standards to procedural updates and project deliverables (FDA CFR 820, ISO 13485, ISO 14971, INCOSE HB Abilities: Ability to establish and maintain effective working relationships with internal team members and external stakeholders. Ability to work with integrity and build trust. Ability to critically review and interpret technical documentation. Ability to lead team members and transfer knowledge of CtQ and other Quality tools and techniques. Ability to clearly convey ideas and concepts verbally, in writing, and via presentations. Ability to handle multiple priorities and consistently meet deadlines through effective time management skills.

Company info

Smiths Medical
Website : http://www.smiths-medical.com/

Company Profile
Provide innovative solutions and superior support to help healthcare professionals and providers ensure safety, enhance patient outcomes, and improve the total cost of care. At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for support in managing chronic illness.

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