Senior Engineer, Advanced Quality at Stryker

Cork, County Cork, Ireland

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor's in a science, engineering or related discipline (Level 8)
A minimum of 2+ years of experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment
Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation

Responsibilities

Influence Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects
Drive reliability engineering, human factors engineering, risk management, and design validation, while ensuring compliance to Stryker quality system, FDA Quality System Regulations, ISO 13485 and other medical device regulations
Develop quality assurance documentation to support new product development process and regulatory submissions
Guide new product development teams through internal quality system requirements to launch new products
Influence cross-functional project teams to build quality into product and/or process design and development activities
Support quality system maintenance by identifying and correcting deficiencies in procedures and practices
Lead risk management for new development products, including risk analysis and development of sound mitigation strategies
Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership
Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process
Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria
Support design engineering and advanced operations team in problem solving
Support Advanced Operations in the definition and development of manufacturing processes and process controls for new products
Use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development
Develop, review, and approve inspection plans, routers, and product drawings for new products
Evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products
Analyze and define critical quality attributes for product and process through risk analysis techniques
Support product design transfers to internal and/or external manufacturing facilities
Evaluate predicate products for relevant quality issues that may impact new product development projects
Participate in collection of initial market feedback on new products and address early concerns
Lead formative and summative studies with our customers and other human factors engineering activities to develop intuitive and safe new products
Lead design validation efforts to ensure new products meet all customer user needs
May lead NC & CAPA, which require expertise in problem solving and root cause analysis

Skills

Reliability Engineering

Human Factors Engineering

Risk Management

Design Validation

ISO 13485

FDA Quality System Regulations

Quality Assurance

Medical Device Regulations

Design Reviews

Manufacturing Processes

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.

Land your dream remote job 3x faster with AI

Try Jobo Free