Staff Clinical Product Engineer
At a glance
Senior Software Engineering role at Abbott. Sylmar · full-time · $114,000–$228,000 base.
techroles summary, based on the employer's posting.
What you'll do
- Lead clinical development across several product projects, coordinating engineering and scientific teams against timelines and budgets
- Gather customer input on clinical workflows, then turn user needs into product features and design validation work
- Set clinical performance benchmarks with field and medical teams, and interpret customer or study data into recommendations
- Develop pre-clinical evaluation plans, analyze results, and document findings for product and management teams
- Evaluate prototypes using electrograms and diagnostic or programming data, while contributing to risk and clinical evaluation records
What you bring
- A bachelor’s degree in an engineering discipline such as biomedical or electrical, or equivalent education and work experience
- At least seven years of progressively responsible work in medical devices or equivalent
- You can apply clinical-use knowledge to resolve project issues and bring strong analytical and problem-solving skills
- You can communicate across employee levels and manage deadlines across multiple projects
Who this fits
This senior role suits an engineer who can lead project teams and clinical development while coaching junior engineers. The position is based in Sylmar, California, includes about twenty percent travel, and involves prolonged standing, frequent keyboard use, and clean-room work.
From the employer
JOB DESCRIPTION:
Job DescriptionWorking 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
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow 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.
JOB FAMILY:
Product Development
DIVISION:
CRM Cardiac Rhythm Management
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
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 environmentAbbott 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
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