Medtronic

Healthcare

ValidationEngineer

$92–138k Neuhausen, Schaffhausen, Switzerland FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Validation Engineer at Medtronic. Skills: Validation leadership, Process validation, Risk management. Lead validation activities during NPI. Lead validation activities during technology transfer”

What You'll Achieve.

Ensure successful product launches

Industry & Context.

Healthcare
Problems you'll solve

Technical problem solving; Analytical problem solving

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, Proven ability to influence cross functional stakeholders, Structured, risk based mindset

Nice to Have

Exposure to automated or 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 subject matter expert

Ensure Design for Manufacturability

Ensure validation readiness

Review product designs

Review specifications

Review manufacturing processes

Lead development of validation deliverables

Execute validation deliverables

Ensure compliant design transfer

Perform risk management activities

Perform process characterization

Perform capability studies

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

Collaborate with Manufacturing; Collaborate with Quality; Collaborate with R&D; Collaborate with Engineering; Collaborate with Supply Chain; Influence technical decisions; Provide guidance to junior engineers; Mentor junior validation engineers; Represent Validation during audits; Represent Validation during inspections; Represent Validation during cross site initiatives

Communication Scope

Documentation skills; Communication skills

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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