Senior Quality Manufacturing Engineer at Stryker

San Jose, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s Degree in a technical field
2+ years of relevant full time experience
Preferred: Bachelor’s in Engineering
Preferred: Knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO13485, ISO9001, etc
Preferred: Experience with Non-Conformances and Corrective and Preventative Actions
Preferred: Ability to express ideas and collaborate effectively with multidisciplinary teams
Preferred: Experience in independently executing moderately complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design
Preferred: Solid analytical skills, ability to plan, organize and implement concurrent tasks
Preferred: Demonstrated mechanical/electrical problem-solving skills
Preferred: Proven ability to handle multiple assignments at once while meeting all deadlines
Preferred: Must be able to routinely make decisions which affect immediate operations
Preferred: Demonstrated ability to plan, track and facilitate projects
Preferred: Understanding of Quality Management System tools, Six Sigma tools, problem solving, root cause analysis, Lean and continuous improvement methodologies, with proven ability to apply them

Responsibilities

Identify and lead implementation of procedure, process improvements of responsible repair lines
Communicate and collaborate with suppliers to solve product and component quality issues
Trend key quality metrics and proactively takes action as needed
Independently review, trend, and process nonconformances for responsible product and components
Troubleshoot product quality issues of moderate complex scope where the analysis requires a variety of factors
Own NCs/CAPAs for responsible product and support overall team in implementation of robust corrective and preventative actions
Ensure compliance of documentation for inspection/testing and repair procedures
Train repair technicians on repair processes and procedure changes
Responsible for processing supplier-initiated requests and necessary supporting documentation
Partner with repair technicians and supervisors to ensure processes and equipment can meet demand requirements
Drive continuous improvement actions/initiatives with suppliers and in-house teams to reduce quality issues, increase performance, reduce lead time, reduce cost, etc
Execute moderately simple validation of equipment
Provide input in the new product development process by using current generation data to identify effective and efficient repair techniques
Support Service in internal and external audits (FDA and Notified Body auditors)
May interact with customers to solve reliability issues and/or answer general product questions

Skills

Process Improvement

Supplier Collaboration

Quality Metrics

Nonconformance Review

CAPA

Troubleshooting

Equipment Validation

FDA Compliance

Audits

Continuous Improvement

Repair Procedures

Regulatory Standards

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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