OverviewPosition 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 $160,000 to $190,000. 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.
ResponsibilitiesKey AccountabilitiesEssential 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.
QualificationsMinimum Knowledge & Experience Required for the Position:- Bachelor's degree in Electrical, Systems, Biomedical Engineering, or related discipline.
- 15 years of relevant engineering experience; 10 years with advanced degree.
International Mobility: Required:Travel requirements: If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
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
