Senior Lead Systems Engineer

Werfen•Bedford, MA

3d•$160,000 - $190,000•Onsite

About The Position

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: The Senior Engineering Group Lead will have a player-coach technical authority for Class II and Class III coagulation programs — you will own design controls, product reliability, and a five-person systems engineering team. This role will assign and oversee the practical application of technology across multiple programs, leading requirements management, risk management, verification and validation, and traceability from design input through design output. You will set system integration and V&V strategy, build the plans, protocols, and validation documentation that stand up to FDA scrutiny, and drive execution with Mechanical, Electrical, Software, Quality, Regulatory, and Project Management. This is a hands-on leadership role: you develop the team, make the technical calls, and still contribute directly on the programs that matter most.

Requirements

Bachelor's degree in Electrical, Systems, Biomedical Engineering, or related discipline.
15 years of relevant engineering experience; 10 years with advanced degree.
Experience with FDA-regulated Class II and/or Class III medical devices.
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.

Responsibilities

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.
Develop 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.