Staff Engineer

Werfen • Bedford, MA

6h • $205,000 - $245,000

About The Position

Werfen is seeking a Staff Systems Architect to lead systems design for next-generation Hemostasis products. The role shapes system architecture for in vitro diagnostic (IVD) products, aligning optical, mechanical, electrical, process-development, and software disciplines. It is responsible for robust performance, reliability, scalability, regulatory compliance, and integration across hardware, software, and reagents. The successful candidate brings systems-level risk management experience, a strategic approach to product innovation, and the ability to translate complex technical information into actionable business decisions. The position also requires mentoring technical talent and coordinating complex milestones across R&D, regulatory, and commercialization teams through effective planning and proactive risk mitigation.

Werfen is a family-owned diagnostics company founded in 1966 and headquartered in Barcelona, Spain. It operates directly in 30 countries and through distributors in more than 100 territories, with a workforce of more than 7,000. Its areas include Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant, as well as customized assays and biomaterials through its OEM business.

The role requires a Master's degree in Engineering or an equivalent scientific discipline and 12 or more years of experience, or an equivalent combination of education and experience. The annual base salary range is $205,000 to $245,000. Travel is less than 5% of the time, and international mobility is not required.

Requirements

• Master's degree in Engineering or an equivalent scientific discipline and 12 or more years of experience, or an equivalent combination of education and experience.
• Recognized authority across broad engineering program areas or in a highly specialized area of considerable novelty and importance.
• Proven record of leading products from concept through commercialization.
• Strong expertise in quality systems and design controls, including ISO 13485 and US FDA 21 CFR Part 820.
• Expertise in medical device hardware platform architecture.
• Expertise in electronics and embedded systems design.
• Experience in electromechanical product development, including IEC 61010 and IEC 62326.
• Expertise in systems engineering principles and architecture methodologies.
• Experience with requirements management and traceability.
• Experience with usability engineering and human factors, including IEC 62366.
• Expertise in risk management, reliability engineering, and DFMEA, including ISO 14971.
• Experience with design controls, verification, and validation.
• Experience making architecture decisions across multidisciplinary engineering organizations.
• Experience with the Software Development Lifecycle and software cybersecurity, including IEC 62304, IEC 82304-1, and IEC 81001-5-1.
• Strong understanding of FDA, MDR, IVDR, IEC, ISO, and other applicable medical device standards.
• Strong communication skills, executive presence, sound technical judgment, and the ability to communicate confidently and professionally in high-stakes technical reviews and customer-facing situations.
• Ability to mentor and develop technical talent and coordinate complex project milestones across R&D, regulatory, and commercialization teams.

Nice To Haves

• INCOSE membership.

Responsibilities

• Lead system architecture and technical strategy for complex medical device and IVD platforms, particularly hardware and electromechanical systems.
• Translate customer needs, intended use, assay performance requirements, and regulatory needs into system requirements, user workflows, architecture, and subsystem interfaces.
• Drive cross-functional technical decisions, trade-off analysis, architecture reviews, and risk assessment across hardware, firmware, software, and systems engineering.
• Define system integration, verification, validation, and reliability strategies aligned with applicable medical device regulations and design controls.
• Govern architecture documentation, requirement baselines, interface specifications, and engineering changes through configuration management, impact assessments, and design reviews.
• Identify and mitigate technical risks, mentor engineering teams, and promote systems engineering best practices.
• Ensure architecture and development deliverables align with applicable medical device and IVD regulations and standards, including FDA Quality Management System Regulations, ISO 13485, ISO 14971, IEC 62304, IEC 62366/HE75, and EU IVDR.
• Communicate technical decisions, trade-offs, and recommendations to technical and business audiences.
• Build cross-functional alignment, influence stakeholders, and support engineering leaders in reaching consensus on architecture, priorities, and technical direction.
• Represent the systems engineering organization in technical reviews and customer-facing situations with accountability and a collaborative, solutions-oriented approach.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan with employer match
• Paid vacation
• Paid sick leave
• Performance-based bonus eligibility for management and select professional roles

What This Job Offers

• Job Type: Full-time
• Career Level: Senior