Sr. Systems Engineer, R&D - BD Advanced Patient Monitoring

Edwards Lifesciences; Irvine (CA); On-site; USD 106,000 - 149,000; Full time

Job summary

An established industry player is seeking a Senior Systems Engineer to join its innovative team dedicated to revolutionizing healthcare. This role involves designing and implementing complex medical systems, ensuring they meet regulatory standards while enhancing patient outcomes. The ideal candidate will possess a strong background in systems engineering and a passion for developing solutions that improve healthcare delivery. With a commitment to cutting-edge technology, this position offers the opportunity to make a significant impact in the medical field while collaborating with a dynamic team. If you're a motivated self-starter ready to take on challenges, this is the perfect opportunity for you.

Benefits

Competitive salaries

Performance-based incentives

Diverse benefits programs

Qualifications

• 3+ years of experience in systems engineering, preferably in MedTech.
• Strong knowledge of regulatory requirements and quality standards.

Responsibilities

• Design and implement complex medical systems and devices.
• Support system requirements development and manage user experience.

Skills

Systems Engineering

Problem-solving

Communication Skills

Interpersonal Skills

Regulatory Requirements Knowledge

Quality Standards Knowledge

Requirement Management Tools

Self-motivated

Education

Bachelor's degree in Systems Engineering

Master's degree in Biomedical Engineering

Master's degree in Electrical Engineering

Master's degree in Mechanical Engineering

Tools

PTC

JAMA

DOORS

Job description

Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such will become a part of the BD organization in the future. Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.

Company Overview: Join our innovative team at BD Advanced Patient Monitoring, a leading MedTech company dedicated to revolutionizing healthcare through cutting-edge technology and advanced algorithms. We are committed to improving patient outcomes and enhancing the quality of life through our advanced hemodynamic monitoring solutions.

We are seeking a highly skilled and experienced Senior Systems Engineer to join our dynamic team. The ideal candidate will have a strong background in medical technology and a passion for developing innovative solutions that make a difference in healthcare. As a Senior Systems Engineer, you will play a critical role in the design, development, and implementation of complex medical systems and devices.

How you will make an impact:

• Write, execute Design Verification Protocols and effectively organize, capture and analyze test results.
• Plan, collect and translate detailed information about how users interact with Critical Care medical devices and connectivity solutions through interviews, direct observation in the field, task analysis, and simulation labs.
• Support System requirements development and management related to device connectivity, usability, user experience, and testing.
• Support Regional Marketing and Sales teams in pre-sale efforts for technical features such as connectivity, functionality, and service features.
• Support communication with hospital IT departments for initial deployment questions, setup, and testing strategy.
• Interface with sales, marketing, and quality/complaint handling organizations to support post-market surveillance efforts.
• Drive technical root cause investigations as necessary, engaging appropriate R&D, quality, and vendor resources.
• Identify/create new product features and partner with Software development team to bring to fruition through clear communication by creating wireframes and storyboards.
• Display effective technical System Engineering skills to navigate the tasks through a large cross-functional team during the product development process.
• May receive technical guidance on the most unusual or complex problems, but independently determines and develops approaches to solutions.
• Will require up to 25% domestic and international travel.

What you’ll need (required):

• Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or Mechanical Engineering.
• Minimum of 3 years of experience in systems engineering, MedTech industry preferred.
• Proven track record of leading the development of complex medical devices from concept to market.
• Strong knowledge of regulatory requirements and quality standards in the medical device industry (e.g., FDA, ISO 13485, ISO 60601).
• Excellent problem-solving skills and the ability to work effectively in a fast-paced, collaborative environment.
• Strong communication and interpersonal skills, with the ability to convey technical information to non-technical stakeholders.
• Previous experience working with requirement management tools such as PTC, JAMA or DOORS.
• Highly motivated self-starter who is able to achieve results with minimal direction.

What else we look for (preferred):

• Prior clinical experience in Critical Care monitoring (hemodynamic monitoring, vital signs monitoring), Interventional, Vascular or Cardiac Surgery arena a plus.
• Good understanding of design controls, such as IEC 62366, ISO 14971, 21 CFR 820 a plus.
• Experience with Device Connectivity and Cloud-based application solutions is desired.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement:

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.