Sr Design Assurance Engineer

Sr Design Assurance Engineer

14 sep
|
Medtronic
|
Departamento de Santa Rosa

14 sep

Medtronic

Departamento de Santa Rosa

POSITION DESCRIPTION:

The Sr. Design Assurance Engineer provides technical leadership and support to the Coronary/RDN post-market team.  The Sr. Design Assurance Engineer focuses on post-market quality related projects and deliverables.  The Sr. Design Assurance Engineer may also provide project management, technical coaching, and decision-making guidance to other post market quality team members.

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 or core 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.
 Provide support to more junior level DAE engineers.

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

• BS in Engineering, Bioengineering
• A minimum of 5 years’ experience, with at least 3 years’ experience in the Medical Device industry

DESIRED/PREFERRED QUALIFICATIONS:
• • A minimum of 3 years’ experience in product & process development
• Supervisory or management experience a plus
Technical
Experience and / or proficient with:
o Statistics, statistical tools and software
 DOE
 ANOVA
 Confidence and Tolerance Limits
 SPC
 DRM
o Process Development, Characterization, and Validation
o Process Improvement Tools
 Lean Manufacturing
 Six Sigma Methodology
o Experience with combination drug/medical device products
o Able to solve very complex problems that require creativity
o Microsoft office (Word,

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