Staff Engineer, Advanced Operations (12-month contract) at Stryker

Tijuana, Baja California, Mexico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree in Industrial Engineering or related engineering discipline
Minimum 5 years of experience in a manufacturing/process engineering role in medical devices or similarly regulated industry
Experience with process validation, capability studies, and data analysis
Experience in textiles manufacturing and composition
Strong understanding of manufacturing processes, materials, and product design
Advanced proficiency with Microsoft Office and analytical tools
Experience in PFMEA (Process Failure Mode and Effects Analysis), PPAP (Production Part Approval Process), and Control Plan development
Advanced English
Preferred: Experience supporting capital equipment projects from specification through validation
Preferred: Ability to interpret complex engineering drawings and apply GD&T (Geometric Dimensioning and Tolerancing) principles

Responsibilities

Provide engineering support for new products and process introductions, ensuring all activities comply with Stryker’s new product development procedures
Ensure product and process quality meet established operational and material specifications
Select components and equipment based on technical specifications, reliability, and regulatory requirements; collaborate with quality engineers on inspection and testing protocols
Support capital acquisition activities including equipment specification, contract negotiation, installation, and validation
Analyze process and equipment data, conduct experiments, and lead process review meetings to drive improvements
Participate in PFMEA (Process Failure Mode and Effects Analysis), Control Plan, SOP (Standard Operating Procedure), and PPAP (Production Part Approval Process) generation for product transfers and new launches
Conduct capability studies and MSA (Measurement System Analysis) for new products and processes, and prepare related inspection documentation
Ensure adherence to GMP (Good Manufacturing Practices), safety, and validation requirements in all manufacturing activities

Skills

Key technologies and capabilities for this role

Process ValidationCapability StudiesPFMEAPPAPMSAGMPSOPControl PlanData AnalysisTextiles Manufacturing

Questions & Answers

Common questions about this position

What are the required qualifications for the Staff Engineer role?

A Bachelor’s degree in Industrial Engineering or related engineering discipline and minimum 5 years of experience in a manufacturing/process engineering role in medical devices or similarly regulated industry are required. Additional requirements include experience with process validation, capability studies, and data analysis; experience in textiles manufacturing and composition; strong understanding of manufacturing processes, materials, and product design; advanced proficiency with Microsoft Office and analytical tools; and experience in PFMEA, PPAP, and Control Plan development.

Is this position remote or onsite?

The position is onsite.

What is the salary or compensation for this role?

This information is not specified in the job description.

What preferred experiences would make me stand out for this position?

Preferred experiences include supporting capital equipment projects from specification through validation and the ability to interpret complex engineering drawings and apply GD&T (Geometric Dimensioning and Tolerancing) principles.

How much travel is required for this role?

The role requires 10% travel.

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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