Senior Mechanical Development Quality Engineer

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Sunnyvale, CA
Job Type
Direct Hire
Mar 26, 2018
Job ID
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We are seeking an experienced, high caliber Senior Mechanical Development Quality Engineer to assure new or modified products conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
  • Act as Core Team Lead and ensure on-time completion of Design Control Deliverables
  • Bring additional development expertise to the product development process
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support and ensure internal & external audit responses
  • Support and ensure on time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Exercise judgment in planning and organizing work; monitors performance and reports status
  • Build strong collaborative partnerships with Program Management and Research & Development to ensure cross functional customer needs are met without creating barriers to development cost, time and scope
  • Complete Document Change Request Reviews in a timely and objective manner
  • Develop and lead other team members
  • Perform other duties and responsibilities as assigned by management
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Performs other related duties and responsibilities, on occasion, as assigned
  • Bachelor level degree in Mechanical Engineering, or similar; Advanced degree
  • 5 years’ experience in a degree-related field
  • Experience with product development (in a Development or Quality role), test method development and validation, test execution, failure analysis and risk management
 ·        Experience with quality systems and standards compliance
  • Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced personal computing skills, including report writing, and familiarity with common MS Office applications
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing Environment
  • Ability to leverage and/or engage others to accomplish projects
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 10%, including internationally
  • Ability to maintain regular and predictable attendance
  • Advanced degree in Mechanical Engineering or similar
  • Experience in the implantable medical device field with experience in Design Assurance, Quality Assurance, Design controls and Risk Management
  • Prior design and development experience in the related field
  • Statistical methods and Critical to Quality training and experience
  • Root cause analysis and Finite Element Analysis experience
  • Experience with Design for manufacturing, Design of Experiment and CAD tools
  • Experience working in a broader enterprise/cross-division business unit model
  • Applicable background in process/product development. 
  • ASQ certification also a plus.
Identifier:  $MEDD,$NEER