Staff Clinical Product Engineer

Thornton Tomasetti; Los Angeles (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Sylmar, CA, within the Cardiac Rhythm Management division, seeks a senior engineer to lead cross-functional teams and drive clinical development across multiple projects.

Responsibilities include planning, supervising, and delivering product development milestones, ensuring regulatory and customer workflow alignment, and mentoring junior engineers while engaging with field personnel and stakeholders.

Qualifications

• Bachelor's degree in biomedical, mechanical, electrical, or similar engineering field or equivalent.
• Minimum 7 years of experience in medical device industry or equivalent.
• Ability to apply clinical understanding to project issues and deliver results.

Responsibilities

• Lead large group of engineers and manage clinical development for multiple projects.
• Plan and implement product development with technical leadership and supervision.
• Ensure objectives, logistics and budgets are met and regulatory requirements are addressed.
• Define clinical/workflow requirements by engaging with customers and translating needs into features.
• Define benchmarks for evaluating clinical performance and drive data-driven decisions.

Skills

Analytical skills

Education

Bachelor's Degree in biomedical, mechanical, electrical engineering or equivalent

Job description

About Abbott

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 115,000 colleagues serve people in more than 160 countries.

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.

Location & Work Details

JOB FAMILY: Product Development

DIVISION: CRM Cardiac Rhythm Management

LOCATION: United States > Sylmar : 15900 Valley View Court

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: Yes

SIGNIFICANT WORK ACTIVITIES:

• Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Keyboard use (greater or equal to 50% of the workday)
• Work in a clean room environment

EEO / Equal Opportunity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

Company Culture

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lives greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

Base Pay

The base pay for this position is $114,000.00 - $228,000.00. In specific locations, the pay range may vary from the range posted.