Job Summary

The Systems Engineer plays a critical role in defining, developing, and integrating systems and software-level requirements for Werfen Autoimmunity’s in-vitro 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, hands-on problem-solving 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 system-level troubleshooting and lifecycle management are essential.

Key Accountabilities

• Supports multiple medium- to large-sized projects associated with the development of new diagnostic instruments or improvements to existing in-vitro 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 required for the position:

Bachelor’s degree in Systems Engineering, Bioengineering, Mechanical Engineering, or a related field with 4-6 years of relevant experience in systems engineering, biotech, or medical device development.  A master’s degree is a plus.  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 ground-up.
• 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 cross-functional collaboration
• Strong analytical and problem-solving skills, including root cause analysis.
• Six-sigma certification prefered
• Statistical analysis skill preferred (DOE, regression analysis, capability studies)
• Experience in a regulated environment (FDA, ISO 13485, IEC 60601-1).
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Travel requirements:
Less than 25% of the time.

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $85,000- $120,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.