Senior Mechanical Engineer

Alere California , MD 20619

Posted 1 week ago

Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Senior Mechanical Engineer is within our IDDM business unit located at Alere San Diego in San Diego, California or Abbott Diagnostics in Scarborough, ME. This role is for a focused engineer who is experienced in instrument development and can deliver high quality results on time and with minimum supervision.

RESPONSIBILITIES:

  • Apply strong engineering practices to the design, development and testing of new and improved IVD instruments, subsystems and components

  • Build consensus in a diverse cross functional/cross site team as well as at contract manufacturers

  • Ability to analyze, resolve and reconcile ambiguous or conflicting requirements

  • Follow phase gate process leading internal/external development resources from concept to release

  • Own successful design verification testing

  • Create reports to support technical reviews and project management office

  • Problem solver - innovative methods to resolving problems or issues

  • Interfaces with other departments as necessary in the product development process

  • Generate detailed written process instructions

  • Maintain records as per company standards

  • Managing stress in stressful situations as appropriate.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships

  • Carries out duties in compliance with established business policies

  • Other duties as assigned, according to the changing needs of the business

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

  • BS in Mechanical Engineering; or equivalent experience/combined education

PREFERRED QUALIFICATIONS:

  • Medical Device Experience

  • Generally 8 years of experience in related field with 5-7 years of progressively responsible positions or verifiable ability

  • In Vitro Diagnostics (IVD) industry device development highly preferred.

  • Excellent understanding of mechanical, thermal, electrical, and optical designs and components, and their interactions as a system to meet system performance requirements

  • Experience with mechanical design software.

  • Demonstrated experience in the development, prototyping, testing and transfer to production of complex EO/Mechanical systems.

  • Systems approach to problem definition, scoping and solving

  • Demonstrated ability to deliver products in a regulated environment and the phase gate process

  • Previous experience working in distributed engineering teams

  • Experience collaborate with internal and external partners and contract manufacturers

  • Ability to analyze, resolve and reconcile ambiguous or conflicting requirements

  • Knowledge of international standards relevant to the development of an IVD product

  • Demonstrable command of federal medical device hardware regulations, e.g. FDA guidance, IEC 61010

  • Preferred: Experience with optical systems and components relative to IVD detection method

COMPETENCIES:

  • Develops Talent: Continually develops his/her own skillset.

  • Drives for Results: Acts ethically and takes accountability for achieving outcomes.

  • Fosters Collaboration: Avoids getting stuck in a "one right way" approach - remains open minded to new ideas.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

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