Senior Systems Engineer

Job Summary

The Senior Systems Engineer plays a critical role in defining developing and integrating systems and softwarelevel requirements for Werfen Autoimmunitys invitro diagnostic (IVD) instruments in accordance with established Inova Diagnostics procedures (Design Control). The Systems Engineer establishes and performs testing (verification and validation) procedures and executes them for products under development and for design changes to existing products. Additionally the Systems Engineer helps to trouble shoot issues with existing systems/instruments/software/reagents as part of the life cycle management under design control.

This role also involves eliciting documenting and managing system and software requirements from various stakeholders including Marketing Research Operations Sales and external customers (Voice of the Customer VOC). The engineer must clearly and effectively communicate design inputs to project teams and provide ongoing support for implementation and clarification.

The ideal candidate possesses technical leadership handson problemsolving skills and the ability to manage multiple projects in a regulated biotech or medical device environment. Strong attention to detail excellent communication skills and proficiency in systemlevel troubleshooting and lifecycle management are essential.

Key Accountabilities

• Supports multiple medium to largesized projects associated with the development of new diagnostic instruments or improvements to existing invitro diagnostic instruments in accordance with established standards and procedures including design control.
• Communicates project status risks and technical challenges to team leads and management.
• Responsible for defining documenting and managing system and software requirements for a project incorporating input from various internal and external stakeholders including Marketing R&D Operations Regulatory and Voice of the Customer.
• Develops system flow diagrams architecture documentation and interface specifications to support system design and integration.
• Participates in and/or performs system integration testing verification and validation activities across a project under minimal supervision.
• Plans executes and analyzes verification and validation (V&V) activities applying statistical tools reliability analysis and process optimization.
• Supports troubleshooting activities failure investigations and risk assessments identifying root causes and implementing corrective and preventive actions.
• Utilizes data analytics and modeling techniques to optimize system performance.
• Ensures compliance and risk management standards.
• Responsible for maintaining the Design History File (DHF) for system instrument and software development projects and contributing to regulatory submissions.
• Participates in technical reviews and evaluations to ensure robust system design and risk mitigation.
• Works closely with Software Hardware Assay Development Quality and Manufacturing teams to support system integration and performance optimization.
• Provides input on and reviews user manuals system specifications and process improvements.
• Mentors junior engineers and provides technical guidance to project teams.
• Leads technical reviews and supports project planning activities to drive successful execution.

Networking/Key relationships

• R&D teams: Assay Development and Biomarker discovery
• Manufacturing and Operations Teams
• Quality & Regulatory Teams
• Global Systems Support
• Software and Hardware Teams (within Werfen or external)

Minimum Knowledge & Experience for the position:

Bachelors degree in Systems Engineering Bioengineering Mechanical Engineering or a related field with 610 years of relevant experience in systems engineering biotech or medical device development. A masters degree is a plus. The ideal candidate would have prior knowledge of System Development Lifecycle (SLDC) concepts and best practices.

Skills & Capabilities:

• Ability to read and interpret the established Werfen procedures.
• Ability to elicit create and manage requirements / Design Inputs from various sources (both inside and outside) Werfen and communicate them to the appropriate project teams.
• Ability to create system flow documents from the groundup.
• Ability to lead influence and motivate people without direct authority. Ability to resolve conflict manage expectations and negotiating skills.
• Excellent written and verbal communication skills for crossfunctional collaboration
• Strong analytical and problemsolving skills including root cause analysis.
• Sixsigma certification prefered
• Statistical analysis skill preferred (DOE regression analysis capability studies)
• Experience in a regulated environment (FDA ISO 13485 IEC 606011).
• Proficiency in Microsoft Office Suite (Excel Word PowerPoint).

Travel requirements:
Up to 10% travel required.

The salary range for this position is currently $110000 $150000 annually. Individual compensation is based on the candidates qualifications for the position including experience skills knowledge education certifications internal equity budget and/or other business and organizational needs.