Senior Group Leader Systems Engineering

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

The Senior Systems Engineering Group Leader is responsible for assigning and overseeing the practical application of technology across multiple programs while ensuring adherence to common system architecture for Class II and Class III medical device programs. The role serves as both a technical authority and people leader requirement management risk management verification and validation activities guiding system integration and cross-functional execution.

The annual base salary range for this role is currently $160000 to $190000. This is a bonus-eligible position. 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 design inputs and design outputs for Class II and Class III medical devices including Requirements Management Risk Management Verification & Validation (V&V) and Traceability.
• Own product reliability strategy and execution across the product lifecycle.
• Lead system integration verification and validation strategies.
• Create development plans protocols and validation documentation.
• Collaborate across Mechanical Electrical Software Quality Regulatory and Project Management teams.
• Drive technical decisions project execution and team development.
• Serve in a player-manager capacity directly leading and developing a five-member systems engineering team while contributing technically to key programs.
• Serve as a technical authority for coagulation programs and system architecture.

Skills & Capabilities:

• Demonstrated leadership of requirement management risk management system integration verification and validation activities.
• Strong understanding of FDA regulations quality systems and product development lifecycles.
• Expertise in Waterfall and Agile methodologies.
• Experience with requirements management risk management and V&V methodologies.
• Medical device design controls knowledge (ISO 13485 ISO 14971 IEC 60601).
• Familiarity with JAMA DOORS or similar requirements tools.
• Excellent communication mentorship prioritization and problem-solving skills.

Minimum Knowledge & Experience Required for the Position:

• Bachelors degree in Electrical Systems Biomedical Engineering or related discipline.
• 15 years of relevant engineering experience; 10 years with advanced degree.

International Mobility: Required:

• No

Travel requirements:

• <5% of time

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 individuals 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 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 7000 employees around the world comprise our Werfen team.