Senior Engineer, Manufacturing / Production

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
Santa Clara, CA
5 - 7 years experience
Salary depends on experience
Posted on 09/21/17


At Abbott, we're committed to helping you live your best possible life through the power of health. For more than125years, we've brought new products andtechnologies to the world -- in nutrition, diagnostics,medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today,94,000 of us are working to help people live not just longer, but better, in the more than150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.



Position Summary

Leads the engineering assessment; design and development of subsystems and other complex designs.

Main Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality system. 

1. Translates requirements into new solutions - Develops requirements and specifications for new and existing engineering designs.
Provides input to product requirements and translates product requirements into component or Subsystem Specifications.
2. Design - Leads and proposes engineering designs. Leads engineering design reviews with CFT and recommends improvements.
Responsible for subsystem design; ensures design solutions are optimized and addresses requirements. Uses technical knowledge and experiences to identify alternative design approaches.
3. Develops Simulations & Prototypes - Develops simulations or prototypes for new / modified subsystem or system designs and performs engineering analysis and testing.
4 .Implements the design of new products and/or product improvements - Implements the design for components or complex subsystems and ensures designs meet established requirements. Responsible for updating / creating detailed design specifications for components or subsystems.
5. Verifies Solution - Responsible for protocol development and verification of subsystem or system designs.
6. Documenting and Managing Change - Justifies changes; quality and regulatory information; and manufacturing readiness information.
Completes change documentation to include technical rationale and formal verification test results.
7. Advances Engineering Expertise - Maintains current technical skills and functional area expertise. Recommends improvements to Engineering policies and procedures.
8. Anticipates and/or Develops/Applies Risk Mitigation - Evaluates engineering technical risks and identifies alternatives; makes recommendations and takes appropriate actions. Integrates inputs and assists in the development and review of risk management documentation including FMEAs; hazards and modes of control.
9. Collaborates across functional areas - Interprets; presents; and delivers information with product team members; scientists; engineers; and other systems development personnel across sites.
10. Ensures quality through design Techniques and Design Alternatives - Leads and participates in Engineering Design Reviews utilizing Engineering Procedures and Engineering Tools; makes recommendations and identifies design alternatives. Consolidates results of separate design elements for design reviews. Performs independent reviewer role for discipline area.
11. Performs Investigations - Leads investigations to determine root cause for complex issues. Arrives at timely conclusions.
12. Maintains adherence to the Quality System - Implements and maintains the effectiveness of the quality system. Follows functional area policies and procedures. Recommends improvements to policies and procedures. Utilizes appropriate experimental; statistical and engineering tools.
13. Obtains Customer Feedback for new and/or Improve Products - Obtains and provides inputs from internal sources and other internal or external customers and integrates inputs into product to achieve engineering goals.
14. Selects; builds and maintain Third Party Manufacturer (TPM) product and partner relationship - For Third Party Manufacturer products; leads the assessment of the proposed design and verification of subsystem or system to meet corresponding requirements.
15. Strategic Orientation - Ensures plans are focused on site and division priorities. Works with cross functional team in collaborative environment.
16. Leads and Mentors - Trains and mentors associate engineers and engineers in design tools and processes.


Receives general direction for engineering activities. Plans; leads and implements complex engineering assignments.
Receives infrequent direction. Completes complex assignments and provides work directions.
Participates in hiring decisions for engineering resources and provides feedback to Engineering Managers.
Provides input on project activities. Plans; organizes; executes and reviews engineering activities. Creates detailed plans for other engineers; reviews project activities and evaluates results.
Demonstrated ability of engineering development with a history of successful new or improved product releases.

Minimum Qualifications

Bachelor's degree in an engineering or closely related discipline preferred.

Appliesengineering technical knowledge for specified engineering discipline for subsystem development. In depth knowledge and understanding of product or discipline. Moderate knowledge of external regulations and standards affecting IVDs and biologics.
4years progressive work experience with degree or sufficient transferable experience to demonstrate functional equivalence to a degree

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