Job description

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: 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. 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. 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. • 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. 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: • 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. International Mobility: Required: • No 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. 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 NAtalentacquisition@werfen.com 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

Requirements

Must-haves

Key Accountabilities
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.
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:
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.
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

Nice-to-haves

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Application prep

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Keywords to mirror

agile

Platform: icims
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401k