Senior Engineering Group Leader - System Engineering

Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

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:

Reporting to the Functional Manager, responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture. Receives requirements specifications from the Projec

UProgram Managers and prepares specifications to design, develop or integrate technologies required to make a product and its specific derivatives. Responsible for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data and any implementation documents. May act as group leader or lead engineer on a major program, perform independent development, and be responsible for a number of smaller projects.

Skill Leveland Background:

• Must have a bachelor’s degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or closely related field. Advanced degree is preferred
• Must have a proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability (7‑10 years experience, team of 5+ people strongly desired)
• Strong project engineering/management capability with expertise in Waterfall and Agile methodologies. Proven ability to plan and deliver complex programs (resource allocations, workload balancing, WBS, PI planning) while leading and developing high performing teams.
• Experience leading the development of test strategies, exploratory evaluations, and formal design verification from early concept through submission readiness.
• Must have experience in design requirements and risk management, with the ability to translate identified and emerging risks into actionable verification strategies and detailed test plans, driving risk mitigation to closure in collaboration with cross‑functional teams.
• Partner with Quality Engineering and Regulatory teams to support audit readiness and contribute to the Design History File (DHF)
• Should have experience in estimating and planning verification and validation activities across the development lifecycle
• Specify detailed and traceable test cases based on system requirements and risk analysis
• Organize and lead defect review meetings with relevant team members. Provide timely updates on test progress, defect status, and overall V&V activities.
• Experience developing and executing comprehensive system strategies for system integration, verification, and validation according to standard operating procedures and design controls.
• Understands compliance concepts and testing requirements (IEC 60601) for Noise/EMI/EMC mitigation.
• Experience with risk management tools (e.g., JAMA, DOORS, Cockpit), with JAMA preferred.
• Must have experience with Design Control & Risk Management according to international standards (ISO‑13485, ISO‑14971) desired.
• Must be familiar with Human Factors & Usability Engineering

About your Leadership:

• Technical authority that helps guide the decision‑making process for Coagulation programs
• Credible leader who can influence with strong organizational and…