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Staff Product Development Engineer - Software job in Santa Clara at Abbott Laboratories

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Staff Product Development Engineer - Software at Abbott Laboratories

Staff Product Development Engineer - Software

Abbott Laboratories Santa Clara, CA Full-Time
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Santa Clara, CA currently has an opportunity for a Staff Product Development Engineer.  You will provide guidance for the design and development of the software used within a Programmable Electrical Medical Systems (PEMS). You'll work closely with product development team to establish product development goals while ensuring market compatibility.

WHAT YOU’LL DO

  • Lead the development and evaluation of software used in PEMS. Manage technical interface with internal and external software development and testing resources, partners, and contractors.
  • Work with team to develop software specifications, create test plans to evaluate the performance of the PEMS system, troubleshoot and resolve issues, and guides the software risk assessment process.
  • Lead team to ensure that the PEMS is resistant to cybersecurity threats. Evaluate potential cybersecurity threats, participates in completing the risk assessment to characterize the threat, and recommends controls and test plans to address the threats. 
  • Ensure development programs meet regulatory and customer requirements through understanding of external regulations and interfacing with appropriate internal and external resources (regulatory, customers, etc.).
  • Guide development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
  • Contribute to business unit and divisional strategy planning.
  • Participate in review boards for intellectual property, CAPA, complaints, business unit planning, and others as necessary.
  • Review and provide functional approval for project and quality system documentation.
  • Track and participate in cross-business technology projects related to PEMS development practices.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirement
  • Compliy with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Review and provide functional approval for project and quality system documentation.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required



Bachelors Degree -Technical field, preferably electrical, software, or electrical systems engineering

Minimum 9 years Medical device development and/or other highly regulated industry.

  • Experience designing and developing software for use in medical systems electrical systems within a regulated environment.
  • Familiarity with application of relevant US and international regulations and standards for software development.  Demonstrated compliance with IEC 62304 required.
  • Experience as systems engineer supporting development of PEMS desirable.
  • 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.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail. 
  • Ability to travel approximately 25%, including internationally.

Preferred

  • Master’s degree in a technical or business field
  • Experience working in a broader enterprise/cross-division business unit model
  • Demonstrated compliance with IEC 60601 and IEC 62304  
  • Experience with Linux based operating system used for software development
  • Proficient with C/C++ or similar coding language
  • Experience with building or modifying custom software code that incorporates open source software.
  • Experience with software development  for medical devices.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • A fast-paced work environment where your safety is our priority
  • Production areas that are clean, well-lit and temperature-controlled
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  [ Link removed ] - Click here to apply to Staff Product Development Engineer - Software

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at [ Link removed ] - Click here to apply to Staff Product Development Engineer - Software, on Facebook at [ Link removed ] - Click here to apply to Staff Product Development Engineer - Software and on Twitter @AbbottNews and @AbbottGlobal.

 

Recommended skills

Documentation
Corrective And Preventive Action (Capa)
Quality Management Systems
Iec 60601
Test Planning
Risk Analysis
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