Staff Clinical Product Engineer

About the role

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.

Responsibilities

• Lead a large group of engineers and scientists and manage the clinical development work for multiple projects within a function, program, or therapeutic area while meeting detailed project timelines and milestones.
• Plan and implement product development projects, providing technical leadership and supervision to others.
• Ensure program objectives are determined and met, logistics are effectively coordinated, and budgets are adhered to. Act as a cross-functional liaison to ensure designs and products meet customer needs and regulatory requirements.
• Understand the business unit’s products and related clinical workflows and learn about competitive product offerings in different geographies.
• Engage with customers throughout the product development cycle, define clinical and workflow requirements for new product/feature development, and represent the Voice of Customer in the product development cycle.
• Drive the translation of customer needs into new projects through clinical review and evaluation.
• Lead work with field and medical personnel to define benchmarks for evaluating the clinical performance of products/features.
• Interpret data from customers, provide insights and recommendations, and assist the team in identifying future product opportunities.
• Drive and lead clinical design documentation such as user needs, feature definition, and design validation to on-time and high-quality completion.
• Develop and direct pre-clinical evaluation protocols, data analysis, and reports.
• Report significant progress and final findings of projects to management and product development staff.
• Simulate or test aspects of new projects to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyze electrograms, diagnostic, or programming data collected from the field or research studies.
• Provide input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
• Supervise and train junior engineers on completing assigned work.
• Support 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.
• Comply 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.
• Perform other related duties and responsibilities, on occasion, as assigned.

Requirements

• 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 the 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 and problem-solving skills.
• Comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills.
• Ability to meet deadlines on multiple projects and 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.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan (employees may qualify in the next calendar year).
• 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 and named one of the most admired companies in the world by Fortune.
• 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.

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.