Solutions Engineer

Job Description

We are seeking a proactive, result-driven and versatile Staff Solutions Engineer to lead strategic technical initiatives across manufacturing operations in a fast-paced, digitally transforming medical device organization. This role sits at the intersection of engineering, digital systems, and operations, combining leadership in project management, requirements engineering, and software validation with a strong commitment to Lean, Agile, and Six Sigma principles to develop and deploy validated, scalable solutions.

KEY RESPONSIBILITIES

Systems Requirements & Engineering

• Lead end-to-end execution of cross-functional operations and engineering projects from scoping and planning through deployment and post-launch support across multiple sites and functions.

• Develop project plans, timelines, and resource strategies, risk registers, and project documentation to deliver validated, audit-ready solutions.

• Elicit and translate operational, business, and user requirements into functional and technical specifications.

• Define architecture, interfaces, and integration points for new and legacy systems, and integrated hardware/software/processes supporting manufacturing operations.

Risk & Compliance Management

• Conduct and document technical risk assessments (e.g., FMEA, software risk) aligned with ISO 14971.

• Ensure system implementations and changes meet ISO 13485, 21 CFR 820/11, and internal operating procedures.

Software Validation & Lifecycle Management

• Develop and execute validation plans for non-product software used in manufacturing and quality processes.

• Collaborate with IT, Systems, QA, and functional owners to ensure validated systems remain compliant through upgrades and change control.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Bachelor’s or Master’s degree in Engineering (Systems, Software, or another related technical field).

• Experience with developing AWS based solutions and front-end and/or back-end software development a plus.

• 3-5 years of experience working in a medical device manufacturing environment, operations engineering, or regulated manufacturing environment.

• Strong knowledge of ISO 14971, ISO 13485, 21 CFR Part 11/820, and IEC 62304.

• Proven track record delivering validated systems that support production, traceability, and business and compliance objectives.

• Demonstrated ability to thrive in rapidly evolving environments with shifting priorities and emerging technologies, and manage multiple priorities within demanding timeframes.

• Direct experience in systems V&V related activities within the medical device industry.

• Demonstrated experience in project planning, systems integration, and cross-functional technical leadership.