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Quality assurnce engineer/R&D Engineer(Medical device preffrebly)

Plymouth, Minnesota, United States
November 09, 2016

Job Title: Assoc R-D Engineer

Duration:- 5+ Months(On W2)

Location: Plymouth, MN

Keyskills:- r&d engineer,quality control engineer,quality engineer, capa fmeca qsr fda gmp glp.


• The primary purpose of this position is to provide Quality Engineering support and leadership to ensure the successful development of Medtronic products. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to ensure compliance and positively influence manufacturing outcomes. In parallel, this person shall also ensure the products are developed in accordance with applicable industry standards, regulatory requirements and customer requirements. Review and evaluate scientific and technical data as it pertains to product and product testing problems. RESPONSIBILITIES • Actively represent Quality Assurance function on CAPA teams. • • Provide guidance to engineering staff and other personnel and ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review. • Identify and manage corrective actions relating to Design History Files for commercialized product • Familiar with components of the design history file, development phase deliverables and how they are inter-connected. • Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks. • Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. • Promotes continuous improvement in design control activities and use of quality tools with design team. • Reviews elements of the supplier selection process and specification reviews with suppliers to ensure that purchased items meet Covidien specifications. - Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices. • Comply with applicable FDA and international regulatory laws/standards and the Covidien Code of Conduct. • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. • Other duties as assigned or required. KNOWLEDGE/SKILLS/ABILITIES • Extensive knowledge of quality tools: - Risk analysis - Highly proficient in math and use of statistical techniques - Root cause analysis - Problem solving approaches • Reading and correcting drawings • Computer literate; use of word processing, spreadsheets • Project management methods and tools • Quality System Regulation (QSR) • Medical Device Directives (MDD) • ISO procedures / Other Nation & International Standards • FDA requirements and guidance • Good Manufacturing Practices (GMP) • Good Laboratory Practices (GLP) • Knowledge of sampling methods • Recognize problems and proactively take corrective measures MINIMUM QUALIFICATIONS Education: • Bachelor s Degree or higher in Science or Engineering (or related field) Experience: • 5+ years experience in Quality Engineering in the medical device industry (or related industry). Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements. Experience in related engineering areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above. Advanced degrees may be used reduce required experience. • Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires preferred. • Self-motivated and committed to a team approach • Strong interpersonal, organizational and project management skills • Strong oral, presentation and technical writing skills • ASQ certification in Quality Engineering areas desirable • Demonstrated skills in decision making preferably across a broad spectrum of Quality Engineering responsibilities Physical Requirements: • Standing • Sitting • Walking • Stairs • Working on parts while looking through a microscope • Manual dexterity • Eye/hand coordination • Significant computer operation