Senior Systems Engineer II

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

Our client is seeking an experienced Systems Engineer to support Software verification within a regulated medical device environment. This person will serve as a hands-on technical lead across software related system investigations, root cause analysis, risk assessments, design changes, and product support activities. This is not a people management role. The right candidate will lead technical workstreams and programs tied to software driven systems, working closely with software, hardware, systems, quality, manufacturing, and regulatory teams to troubleshoot complex issues and drive deliverables to closure.

The annual base salary range for this role is currently $130,000 to $160,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. 

Key Accountabilities:

Essential Functions:

• Lead software and systems engineering workstreams tied to investigations, root cause analysis, risk assessments, design changes, and product support activities
• Troubleshoot software driven system issues across software, hardware, firmware, electrical components, boards, interfaces, configurations, workflows, and integrated product platforms
• Support investigations for product defects, field issues, manufacturing issues, complaints, CAPAs, system failures, and performance concerns
• Assess the technical impact of component swaps, board swaps, software changes, firmware updates, configuration changes, and system modifications
• Review technical data, logs, test results, trends, and investigation outputs to help determine root cause, risk, and next steps
• Document investigation findings, technical rationale, impact assessments, risk evaluations, and recommended corrective actions
• Support design control activities, including technical documentation, specifications, test plans, protocols, reports, traceability, and risk documentation
• Partner cross functionally with systems, software, hardware, electrical, quality, manufacturing, regulatory, and operations teams to resolve technical issues
• Lead or support development of test methods, troubleshooting approaches, technical processes, specifications, and system level verification activities
• Coordinate technical inputs across functions to keep programs, investigations, and deliverables moving
• Communicate technical issues clearly through documentation, presentations, technical summaries, and team discussions
•  

Secondary Functions:

• May review and provide input to deliverables from other functions.
• Recommends and leads implementation of improvement initiatives to aid department practices.
• May be assigned CAPA ownership.

Internal Networking/Key Relationships:

To be determined based on department needs, to include interactions such as:

• Will interface on a regular basis with groups across the organization as needed

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Statistical Analysis (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking
• Technically adept and confident
• Leadership: Accountability, Decision Making, Influence, Communication
• Mentoring

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree in Engineering, Science or a related field

Experience:

• Ten years of product development or relevant experience
• Six to eight years of product development or relevant experience for advanced degrees
• For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

International Mobility:

• Required: No

Travel Requirements:

• Some domestic and international travel may be required.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com