Staff Clinical Product Engineer

Thornton Tomasetti; California; On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott, a global healthcare leader, seeks a Staff Clinical Product Engineer in Sylmar, CA. The role leads engineers and scientists, drives clinical development across multiple projects, and ensures regulatory and customer needs are met throughout the product lifecycle.

Responsibilities include defining clinical/workflow requirements, leading design validation, and coordinating pre-clinical studies, with travel up to 20% internationally.

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical, or similar engineering field, or an equivalent combination of education and work experience
• Minimum 7 years of progressively more responsible work experience in medical device industry or equivalent
• Demonstrated ability to apply understanding of clinical application to issues to bring tasks to resolution
• Strong analytical, problem solving and communication skills
• Ability to travel approximately 20%, including internationally.

Responsibilities

• Lead a large group of engineers and scientists and manage the clinical development work for multiple projects
• Plan and implement product development projects with technical leadership and supervision
• Ensure programs meet objectives, are properly resourced, and budgets adhered to
• Engage with customers to define clinical/workflow requirements and translate into new projects
• Define benchmarks for evaluating clinical performance and supervise training of junior engineers
• Develop pre-clinical evaluation protocols, data analysis and reports
• Comply with FDA regulations and support regulatory submissions
• Collaborate across R&D value chain from ideation to product development for smart medical devices

Skills

Leadership

Project management

Clinical development

Regulatory knowledge

Communication

Travel readiness

Education

Bachelor's degree in biomedical/mechanical/electrical engineering

Master’s or Doctoral degree in biomedical/mechanical/electrical engineering

Job description

## Staff Clinical Product EngineerApplylocations: United States - California - Sylmartime type: Full timeposted on: Posted Todayjob requisition id: 31157250Abbott 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 115,000 colleagues serve people in more than 160 countries.## **JOB DESCRIPTION:**Job Description**Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:* Career development with an international company where you can grow the career you dream of.* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.* An excellent retirement savings plan with high employer contribution.* Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**The Opportunity****This position works out of our Sylmar, CA location in the Cardiac Rhythm Management Division.** As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.**What You’ll Work On*** Lead large group of engineers and scientists and manage the clinical development work for multiple projects within a function, program or therapeutic area and able to meet detailed project timeline and milestones* Plan and implement product development projects, and provide technical leadership and supervision to others* Ensure program objectives are determined and met, logistics are effectively coordinated, and budgets are adhered to. Act as cross-functional liaison to ensure designs and products are meeting customer needs and regulatory requirements.* Understands the business units products and related clinical workflows and know or able to learn about competitive product offering in different geographies* Engages with customers throughout product development cycle, defines clinical and workflow requirements for new product/feature development and represent the Voice of Customer in product development cycle, and drives the translation into new projects through clinical review and evaluation.* Lead the work with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.* Able to interpret data from customers, provide insights and recommendations, and assist the team to identify future product opportunities* Can drive and lead clinical design documentation such as user needs, feature definition, and design validation, and drives them to on-time and high quality completion.* Drives, Develops and directs pre-clinical evaluation protocols, data analysis, and reports* Reports significant progress and final findings of projects to management and product development staff in the company.* Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies.* Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.* Ability to supervise and train junior engineers on completing assigned work.* Help along the entire R&D value chain during ideation, research, product design & development to create smart and connected medical devices with intuitive workflows* Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.* Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains 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.**Required Qualifications*** Bachelors Degree in biomedical, mechanical, electrical, or similar engineering field, or an equivalent combination of education and work experience* Minimum 7 years of progressively more responsible work experience in medical device industry or equivalent* Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.* Strong analytical, problem solving skills* Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees.* Ability to travel approximately 20%, including internationally.**Preferred Qualifications*** Master’s or Doctoral Degree in biomedical, mechanical or electrical engineering, or a biological or physical science or medicine* Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred.* Fluent in medical procedure terminology and sound knowledge of cardiac anatomy* Demonstrated experience in authoring or co-authoring peer-reviewed scientific publications* Medical device experience in the cardiac space preferred**Apply Now****Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.**The base pay for this position is**$114,000.00 – $228,000.00In specific locations, the pay range may vary from the range posted.