Design Assurance Engineer

Design Assurance Engineer

14 sep
|
Medtronic
|
Departamento de Santa Rosa

14 sep

Medtronic

Departamento de Santa Rosa

The Design Assurance Engineer provides technical quality engineering support to the Coronary/RDN post market team.  The Design Assurance Engineer focuses on post-market quality related projects and deliverables.  The Design Assurance Engineer may also provide support to pilot manufacturing quality initiatives, post market design changes/improvements and quality surveillance activities. 

POSITION RESPONSIBILITIES:
 Provide Design Assurance Engineering (DAE) and technical quality support to project teams in the Product Development Process or in support of post market changes.
 Execute quality deliverables required by the Product Development Process, Post Market Change Process or Supplier Change Control Process.




 Prepare the design verification test protocols and reports.
 Support the execution of all design verification and validation activities including overseeing testing. Coordinate with all supporting functions (e.g. Test Lab, Microbiology, etc.) to meet project milestones.
 Lead all design verification and validation activities, including the determination of statistically relevant sample sizes.
 Serve as a quality extended team member on new product development project teams or post market change teams.
 Lead the risk management activities including the creation of the preliminary hazard analysis, Design-FMECA, Post Market Surveillance (PMS) Reports and support risk management document changes due to post market quality activities (PEC, PIA etc).
 Identify and understand design related product failure modes.
 Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
 Partner with R&D;, Operations, Regulatory Affairs and Component Engineering during all product development phases.
 Support the pilot manufacturing line by performing Quality Review and NCMR support.
 Provide support for the creation of design control documents, such as specification documents, process instructions, and receiving inspection documents.
 Support development and validation of clinically relevant test methods.
 Monitor design capability metrics to assure design robustness.
 Support cross functional pre and post-market root cause analysis teams.
 Communicate any quality related problems and issues to DAE / QA management, support the remedial, corrective and preventative actions and ensure closure of the problem / issue.
 Support design reviews for pre and post market projects.
 Support preparation of design dossier and regulatory submissions. Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
 Have a solid understanding of compliance regulations and requirements.
 Support the Quality System to achieve FDA facility registration and ISO certification / CE marking.
 May provide quality support to pilot manufacturing operations, quality initiatives, and support production quality issues resolution.
 May perform validations to implement new tests and / or test equipment.
 May support CAPA’s and audit’s (internal and external).
 May make updates and improvements to the test & inspection methods, inspection forms and related documentation used to evaluate product functionality and quality.
 May support customer complaint analysis and complaint trending.
 May support Product Impact Assessments.
 May support Product Evaluation Committees.

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

• BS in Engineering, Bioengineering with 2 years’ experience

DESIRED/PREFERRED QUALIFICATIONS:
• MS in Engineering, Bioengineering, or Biotechnology desired
• Experience in product & process development
• Experience with medical device product and or process risk management
• Experience with developing new products or supporting commercial activities for class 3 medical devices
• Experience with medical device regulations and standards such as ISO 13485 and CFR 21 Part 820
• Proficient with statistics, statistical tools, and software
• Experience with process Development, Characterization, and Validation
• Experience with process improvement tools (i.e. Lean Manufacturing and Six Sigma)  
• Experience utilizing Microsoft office (Word, Excel, PowerPoint, Visio)
• Experience with Solid Works
• Master’s

Busco empleo medio día mantenimiento

Busco empleo medio día mantenimiento

19 sep
|
Daniel Chiera
|
Departamento de Godoy Cruz
  • 19 sep
  • Daniel Chiera
  • Departamento de Santa Rosa

Necesito empleo medio día de mañana, para mantenimiento de hoteles, restaurantes etc . Soy técnico en aires acondicionados y calefacción central. Fusión de cañerías de agua, gas etc . Lo que se [...]

Fletes en Mendoza

Fletes en Mendoza

19 sep
|
Matías
|
Departamento de Maipú
  • 19 sep
  • Matías
  • Departamento de Santa Rosa

Se realizan fletes en Mendoza Camion con volquete y camioneta Consultas WhatsApp o llamadas 2615377555 [...]

Telefonista y choferes

Telefonista y choferes

19 sep
|
Marcelo
|
Villa Adelina
  • 19 sep
  • Marcelo
  • Departamento de Santa Rosa

Para remiseria en Villa Adelina presentarse en Rioja 1925 ,telefonista de 21a A 55a con conocimiento en PC para el horario de 23 a 7 hs pesos 8000, y choferes para ambos turnos categoría de registro [...]

mantenimiento en gral rodriguez

mantenimiento en gral rodriguez

19 sep
|
rodriguez
|
Mendoza
  • 19 sep
  • rodriguez
  • Departamento de Santa Rosa

construccion-remodelaciones plomeria-metalurgica-yesero-pintor de obras colocacion de ceramica-porcellanato durlock- techos presupuesto sin cargo tel -155154478 [...]

CHOFERES AMBOS TURNOS

CHOFERES AMBOS TURNOS

19 sep
|
Marcelo
|
Partido de San Isidro
  • 19 sep
  • Marcelo
  • Departamento de Santa Rosa

Presentarse en Rioja 1925 Villa Adelina con registro categoría d1 buena presencia [...]

Suscribete a esta alerta:
Escribe tu dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: design assurance engineer
Publica un nuevo anuncio gratuito
Necesitas publicar un anuncio? Con más de 1 millón de usuarios únicos al mes en corto encontrarás el candidato ideal para tu empresa, ¿qué estás esperando!
Publica ahora

Suscribete a esta alerta