Manufacturing Validation Engineer

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. 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.

Position Summary
We are seeking a proactive, results-driven, and versatile 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, 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, including integrated hardware, software, and 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 Part 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.

Qualifications

• Bachelor’s or Master’s degree in Engineering (Systems, Software, or another related technical field).
• Experience developing AWS-based solutions and front-end and/or back-end software development is a plus.
• 3–5 years of experience in a medical device manufacturing environment, operations engineering, or other 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/compliance objectives.
• Demonstrated ability to thrive in rapidly evolving environments with shifting priorities and emerging technologies.
• Ability to manage multiple priorities within demanding timeframes.
• Direct experience in systems verification & validation (V&V) activities within the medical device industry.
• Demonstrated experience in project planning, systems integration, and cross-functional technical leadership.

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