Staff Process Engineer, Advanced Operations at Stryker

Tempe, Arizona, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

4+ years of relevant work experience – required
Bachelor's Degree in Engineering – required
Bachelor's degree in Industrial or Systems Engineering - highly preferred
Lean Six Sigma Green Belt Certification or above – preferred
Knowledge of manufacturing processes, materials, product, and process design – preferred
Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques – preferred
Ability to read and interpret complex engineering drawings and have understanding of geometrical dimensioning and tolerancing – preferred
Experience writing and executing validations – preferred
Experience in new production introduction or manufacturing engineering – preferred
Experience in an FDA regulated or regulated industry – preferred

Responsibilities

Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures
Ensure quality of process and product as defined in the appropriate operation and material specifications
Drive and execute effective communication with all stakeholders to enable project success
Assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements
Lead/support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation
Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals
Analyze equipment to establish operating data and conduct experimental test and result analysis
Lead/participate in process review meetings
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches
Complete capability studies for in-process inspection and generate subsequent inspection documentation
Conduct qualifications, validations, and MSA studies for new products and new processes. Review and approve validation documentation
Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures

Skills

Process Engineering

New Product Introduction

PFMEA

Control Plan

PPAP

Capability Studies

Process Validation

MSA

GMP

Lean Six Sigma

DFM

Statistical Tools

Equipment Validation

Capital Acquisition

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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