Staff Engineer: Validation at Stryker

Skawina, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

Proficiency in Medical Device Validation and QA
Bachelor of Science in Engineering or related subject with 3 to 5 years of experience in GMP validation
Working knowledge/experience of Risk Based Techniques (e.g., FMEAs, FTAs)
Good understanding of statistical techniques, particularly statistical sampling plans, Process Capability, and Gauge R&Rs
Excellent knowledge of all validation elements (all validation documents and specialties)
Good influencing and communication skills, with a practical and compliant approach and awareness of industry best practices
Fluency in English
Polish (preferred)
Lean Six Sigma training (preferred)
Applicable knowledge of statistics (preferred)

Responsibilities

Provide technical guidance and perform validation reviews as both QA and validation approver
Set validation strategy for projects
Act as Subject Matter Expert for special validation skillsets (e.g., Computer System Validation (CSV), Qualification of Buildings, Facilities and Utilities (BFU), Measuring System Analysis (MSA)) and work as part of cross-functional local and global teams
Act as an Administrator in Stryker's electronic Validation Lifecycle Management System (eVLMS) ValGenesis for several sites
Guide the definition of validation strategies for highly complex validation projects (multiple sites)
Mentor and train Stryker personnel in validation, expand own expertise by training in other areas of validation, and coordinate validation certification of engineers
Support internal, corporate, and external audits, if required
Use quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to build quality into new and existing products
Lead continuous improvement projects: implement lean and Six Sigma initiatives to assigned projects and lead teams to apply these methodologies
Coach and guide multifunctional engineering teams to establish and meet validation and process development corporate requirements
Provide technical expertise and define best practices for local validation teams

Skills

Key technologies and capabilities for this role

Medical Device ValidationGMP ValidationComputer System ValidationCSVBFU QualificationMSAValGenesisSix SigmaLeanStatistical MethodsQuality Engineering

Questions & Answers

Common questions about this position

What is the salary for the Staff Engineer: Validation position?

This information is not specified in the job description.

Is this a remote, hybrid, or on-site role?

The role offers hybrid work flexibility and is based at the new manufacturing site in Skawina.

What key skills and experience are required for this role?

Required skills include proficiency in Medical Device Validation and QA, a Bachelor of Science in Engineering or related field with 3-5 years of GMP validation experience, working knowledge of risk-based techniques like FMEAs and FTAs, understanding of statistical techniques such as Process Capability and Gauge R&Rs, and excellent knowledge of all validation elements. Strong influencing and communication skills are also needed.

What does the team structure look like for this position?

The role is part of the Global GQO-QA Validation team, involving coaching and guiding multifunctional engineering teams, acting as a subject matter expert across cross-functional local and global teams, and responsibility for local validation teams.

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

Strong candidates will have required proficiency in Medical Device Validation and QA with 3-5 years GMP experience, plus preferred Lean Six Sigma training, and demonstrate excellent communication skills and industry best practices awareness.

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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