Systems/Controls Engineer II

Worklane GmbH; Kirkwood (MO); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan and company match

Tuition reimbursement program

Paid vacation and sick time

Floating holidays

Job summary

Worklane GmbH is seeking a Software-focused Systems Engineer in Kirkwood, MO. This position supports a medical device program, ensuring software verification and validation processes meet compliance standards. Responsibilities include regression testing, leading service software validation, and contributing to product cybersecurity activities.

The ideal candidate holds a Bachelor's in Engineering or Computer Science, with 3–7 years of relevant experience. Preferred qualifications include familiarity with medical device standards and scripting knowledge.

Qualifications

• 3–7 years of engineering experience with a focus on software.
• Demonstrated ability to interpret and review software documentation.
• Experience in the medical device industry is preferred.

Responsibilities

• Plan and execute regression testing for software releases.
• Perform software verification and validation in compliance with QMS.
• Lead validation of service software in coordination with stakeholders.
• Maintain the software V&V plan and coordinate with test engineers.

Skills

Software verification and validation

Strong communication

Organizational skills

Self-motivated

Education

Bachelor's degree in Engineering or Computer Science

Tools

MS Office

Aras PLM

D2

Job description

Location: US-MO-Saint Louis Kirkwood, US

Objective

The candidate will serve as a software-focused Systems Engineer supporting a medical device program through post‑submission activities. This role partners with the systems team and engineering subject matter experts (SMEs) and is responsible for software verification and validation (V&V), service software validation, and remediation of third‑party software documentation. Key responsibilities include supporting external suppliers, contributing to cybersecurity activities, and ensuring compliance with regulatory and quality requirements. The role requires strong organizational skills, the ability to manage multiple concurrent assignments, and a high degree of independence.

Responsibilities

• Plan and execute full regression testing for the latest software releases, including authoring and maintaining test protocols and reports.
• Perform software verification and validation in accordance with the B+L Quality Management System (QMS), ensuring traceability to system and product requirements.
• Lead validation of service software in coordination with the service organization and cross‑functional stakeholders.
• Transition third‑party software documentation in‑house; update and restructure key artifacts (e.g., Software Requirements Specification (SRS), Software Design Specification (SDS), Software Architecture Description (SAD)) to support ongoing development and maintenance.
• Author and maintain software documentation aligned to the appropriate Level of Concern (per IEC 62304 and FDA guidance); address gaps identified during Design History File (DHF) remediation efforts.
• Support the Software Field Upgrade Procedure, including documentation development, validation activities, execution of dry runs, and release readiness.
• Provide software support to the external probe manufacturer, including maintenance of associated requirements, design, and test documentation.
• Contribute to product cybersecurity activities, including threat modeling, security risk assessments, and development/maintenance of cybersecurity documentation.
• Support integration of software requirements into the B+L QMS (including traceability matrices) and harmonize software‑related hazards across risk management files.
• Apply relevant industry standards and regulatory requirements across all deliverables.
• Maintain the software V&V plan and coordinate with test engineers, software engineers, and external suppliers to ensure timely execution and documentation.
• Support post‑submission DHF remediation activities related to software.

Qualifications

Minimum requirements:

• Bachelor's degree in Engineering (Computer, Software, Systems, Biomedical, or Electrical), Computer Science, or equivalent experience.
• 3–7 years of engineering experience, with a strong emphasis on software.
• Demonstrated ability to interpret, develop, and review software requirements, design, and test documentation.
• Strong communication and organizational skills.
• Self‑motivated with the ability to work independently and manage multiple priorities.

Preferred requirements:

• Experience in the medical device industry, including software V&V, regression testing, and development of software documentation (SRS, SDS, SAD, test protocols and reports).
• Working knowledge of relevant standards and regulations, including IEC 62304, ISO 14971, IEC 62366, FDA premarket software guidance, 21 CFR Part 11, and EU MDR.
• Familiarity with medical device cybersecurity practices.
• Experience remediating or internalizing third‑party software documentation.
• Experience with scripting or test automation and ability to read source code (e.g., C/C++, C#, Python).
• Familiarity with tools such as MS Office, Aras PLM, and D2.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Benefits

U.S. based employees may be eligible for short‑term and/or long‑term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.