Medtronic
Healthcare
ValidationEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Validation Engineer at Medtronic. Skills: Validation Leadership, Process Validation, Design Transfer. Lead validation activities during NPI. Lead validation activities during technology transfer”
What You'll Achieve.
Successful product launches
Industry & Context.
Technical problem solving; Analytical problem solving; Risk based mindset
What They're Looking For.
Must Have
Bachelor's or Master's degree in Engineering, 7+ years of experience in validation, Experience with validation lifecycle management (IQ/OQ/PQ), Experience in MedTech or pharmaceutical manufacturing, Solid understanding of GMP, Solid understanding of ISO 13485, Solid understanding of regulatory expectations, Technical and analytical problem solving skills, Ability to work independently, Ability to lead complex validation activities, Excellent documentation skills, Excellent communication skills, Proven ability to influence cross functional stakeholders, Structured, risk based mindset
Nice to Have
Exposure to automated production environments, Exposure to high volume production environments
What You'll Do.
Lead validation activities during NPI
Lead validation activities during technology transfer
Define process validation strategies
Own process validation strategies
Execute process validation strategies
Act as validation SME during design transfer
Ensure Design for Manufacturability
Ensure validation readiness
Review product designs
Review product specifications
Review manufacturing processes
Lead development of validation deliverables
Execute validation deliverables
Ensure effective design transfer
Ensure compliant design transfer
Support engineering runs
Lead engineering runs
Support ramp up to production
Lead ramp up to production
Identify technical risks
Assess technical risks
Mitigate technical risks
Identify validation risks
Assess validation risks
Mitigate validation risks
Serve as validation technical authority
Lead investigations for deviations
Lead investigations for CAPAs
Lead investigations for change controls
Ensure processes remain validated
Ensure systems remain validated
Support continuous improvement initiatives
How You'll Work.
Team & Collaboration
Cross functional stakeholders; Manufacturing; Quality; R&D; Engineering; Supply Chain
Communication Scope
Documentation; Communication
Full Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** Relieving pain, restoring health, and extending life — it is guided by this mission that Medtronic continues to bring its innovative therapies to millions of patients. Today, you have the opportunity to join the world’s largest medical device company and take part in this daily challenge. By joining our teams, you will be at the heart of our values. **Responsibilities may include the following and other duties may be assigned:** Validation Leadership – NPI & Design Transfer * Lead validation activities during New Product Introduction (NPI) and technology transfer to manufacturing * Define, own, and execute process validation strategies aligned with product, process, and regulatory requirements * Act as the validation subject matter expert during design transfer phases * Partner with R&D to ensure Design for Manufacturability (DfM) and validation readiness early in development * Review product designs, specifications, and manufacturing processes to ensure robustness and compliance * Lead the development and execution of validation deliverables, including: process validation (IQ/OQ/PQ), equipment and system qualification, test method validation (where applicable) * Ensure effective and compliant design transfer through: risk management activities (e.g., FMEA), process characterization and capability studies, complete, audit ready documentation aligned with regulatory expectations * Support and lead pilot builds, engineering runs, and ramp up to high volume production * Proactively identify, assess, and mitigate technical and validation risks to ensure successful product launches Manufacturing & Sustaining Support * Serve as the validation technical authority for manufacturing operations * Lead investigatio
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