Mechanical Development Quality Engineer

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Sylmar, CA
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/22/17

30052925

JOB DESCRIPTION:

We are seeking an experienced, high caliber 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. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott:

  • 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 crossfunctional 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

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

  • 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

Your preferred qualifications and education:

  • 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,
  • ASQ CE or other professional certifications
  • Experience working in a broader enterprise/cross-division business unit model
  • Working knowledge of ISO 13485, ISO 14971, EN-45502, IEC 60601.
  • Work in Active implantable medical devices . 
  • Applicable background in process/product development. 
  • ASQ certification also a plus.
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