Staff Validation Engineer at Stryker

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Proficiency in Medical Device Validation and QA
Bachelor of Science in Engineering or related subject with 4+ years of experience in validation GMPs
Good understanding of engineering and machine tool fundamentals
Self-starter with demonstrated efficient work methods, analytical & problem-solving skills, and ability to handle multiple tasks in a fast-paced environment
Willingness to travel 20%

Responsibilities

Provide interpretation and guidance on regulations, corporate, divisional, and site local procedures related to validation activities
Participate in the Corporate Validation Team to develop and revise validation procedures and templates to ensure regulatory compliance and company objectives
Participate in corporate and local validation teams to discuss, give feedback, and approve revisions to validation procedures
Represent validation at internal and external audits
Work as part of cross-functional local and global teams, including visiting manufacturing sites on a hybrid basis
Guide the definition of validation strategies for highly complex validation projects across multiple sites
Ensure validation practitioners receive training and coaching to support or perform validations
Ensure appropriate systems are in place to evaluate changes to validated/qualified systems
Use quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to build quality into products
Implement and develop Stryker's validation process for newly acquired sites as part of mergers and acquisitions teams
Work closely with product transfer, NPI, NPD, and AO teams
Lead validation continuous improvement projects
Implement lean and Six Sigma initiatives on assigned projects and lead teams in applying these methodologies
Serve as Subject Matter Expert for at least 2 validation specialties (e.g., CSV, BFU qualification, MSA) and provide primary support

Skills

Key technologies and capabilities for this role

Validation EngineeringQuality AssuranceRegulatory ComplianceValidation ProceduresProcess DevelopmentAudit RepresentationCross-functional CollaborationRisk AssessmentProcedure TemplatesGMP

Questions & Answers

Common questions about this position

Is this a remote position or onsite?

This is an onsite role with hybrid work involving visits to manufacturing sites per project requirements.

What benefits are offered for this contract role?

This is a contract role with full Stryker benefits.

What key skills are required for the Staff Validation Engineer role?

Key skills include knowledge of regulations and procedures for validation activities, use of quality engineering tools, statistical methods, design and process development methods, and expertise in lean and Six Sigma initiatives.

What is the team structure for this position?

This is an individual contributor role within the Global GQO-QA Validation team, involving coaching multifunctional engineering teams and responsibility for local validation teams.

What makes a strong candidate for this Staff Validation Engineer position?

Strong candidates are collaborative partners who build cross-functional relationships, detail-oriented process improvers who optimize work processes, and goal-oriented developers who deliver safe solutions while working independently with minimal supervision.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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