SENIOR RELIABILITY 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 Devices, OrthopaedicsIndustries

Requirements

Bachelor’s Degree in Engineering or related field of study
3+ years’ experience in the Medical Device Industry; preferably in Post-Market Surveillance
Demonstrated applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive
Demonstrated ability to manage and lead complex or broad scope projects
Demonstrated ability to deliver positive, energetic support to a team, and to be an advocate for product excellence and quality
Demonstrated results orientation, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines
Demonstrated verbal, written and interpersonal skills
Demonstrated problem solving and troubleshooting skills
Applied knowledge of Microsoft Office software including Excel, Word and Power Point

Responsibilities

Ensure timely closure of complaint records to comply with FDA and other competent authorities’ requirements
Monitor key process indicators and make suggestions on areas requiring increased focus to management
Mentor, oversee and approve the work of other team members
Work in a team environment with members of the Post market intelligence group on achieving team metrics requirements
Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action
Organize a cross functional team to help identify problem issue and drive product improvement process
Provide support to the new product development and risk management process
Work with all products, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective
Participate and lead in continuous improvement and process re-engineering projects in support of Stryker Orthopaedics' continuous improvement initiatives
Perform engineering analysis to determine root cause and corrective action
Attend job-pertinent training classes

Skills

Root Cause Analysis

Corrective Action

Post-Market Surveillance

ISO 13485

ISO 9001

Quality System Regulation

Medical Device Directive

Failure Investigation

Risk Management

Continuous Improvement

Project Management

Cross-Functional Team Leadership

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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