Manufacturing Validation Engineer
Job Description
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.
- 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.
- 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.
- 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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Meet Your Recruiter
Nina McCann
On-Site Manager
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.