Project Engineer - Validation at Stryker

Skawina, Lesser Poland Voivodeship, Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering
Hands-on experience with validation processes, including equipment qualification, performance qualification, and process qualification
Familiarity with FDA, ISO, GMP standards, and quality assurance methodologies
Strong problem-solving abilities to troubleshoot and optimize validation processes
High level of precision in documenting validation processes and results, with a strong documentation bias to manage the entire validation process
Enthusiasm for collaborative work with excellent verbal and listening skills to effectively share information within the team
Proficient in Polish and English
"Right First Time" Mentality: Commitment to quality and accuracy, understanding that your work has a direct impact on patient health
Additional Skills: Experience with Six Sigma, Cp, Cpk, and MSA practices is an advantage

Responsibilities

Collaborate with cross-functional teams to ensure project compliance with regulatory standards and optimize performance
Develop User Requirements Specifications and assist in device procurement, development, and commissioning
Lead validation efforts by creating and managing FAT, SAT, IQ, OQ, OQ-P, EQ, and PQ processes in the Val-G database, ensuring thorough documentation
Ensure manufacturing processes yield consistent, reproducible results; evaluate systems, conduct tests, and document findings to meet company and regulatory standards
Manage protocol approval sessions with Validation Representatives, support the Product Transfer Process team, and serve as the validation expert for ISO 13485 compliance
Initiate and upload PFD PFMEA, PCP, DMR, DHR, PRT, ECR, and ECN documents to onePLM, ensuring timely release and updates
Develop and execute training plans for Capability, MSA, and other processes, coordinating with Process Engineers for timely document release and training plans in onePLM

Skills

Key technologies and capabilities for this role

ValidationFATSATIQOQPQISO 13485PFMEAMSAUser Requirements SpecificationsChange ManagementonePLM

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The position offers a hybrid work flexibility.

What degree and experience are required for this role?

A Bachelor’s degree in Quality, Biochemistry, Mechanical, Chemical, Materials, or Automation Engineering is required, along with hands-on experience with validation processes including equipment qualification, performance qualification, and process qualification.

What key skills and standards knowledge are needed?

Candidates need familiarity with FDA, ISO, GMP standards, and quality assurance methodologies, strong problem-solving abilities, precision in documentation, and proficiency in Polish and English.

What is the company culture like for this role?

The role involves thriving in dynamic environments, contributing to innovative projects in a team-oriented setting, and collaborating with cross-functional teams like process engineers and quality assurance.

What makes a strong candidate for this Project Engineer position?

Strong candidates demonstrate a 'Right First Time' mentality with commitment to quality and accuracy, enthusiasm for collaborative work, excellent verbal and listening skills, and experience with Six Sigma, Cp, Cpk, and MSA practices.

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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