(Senior) Manufacturing Engineer at Stryker

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Medical DevicesIndustries

Requirements

Proficiency in programming, setup, and operation of 5-axis tool grinders according to customer drawings
Advanced engineering competencies and systems training to support manufacturing areas or projects
Knowledge of OS and Material specifications for process and product quality
Understanding of GMPs and system safety requirements
Experience with PFMEA, Control Plan, SOP, and PPAP generation for product transfers and scale-ups
Capability to support capital acquisition, including equipment specification, contract negotiation, installation, and validation
Proficiency in providing training to manufacturing teams
Ability to interface with Materials Science, Design, and Quality Assurance departments
Skills in system and process troubleshooting with teams and external agents
Experience leading and participating in cross-functional and cross-divisional process improvement initiatives
Ability to identify, quantify, and implement cost reduction opportunities
Engineering support for new product and process introductions in Advanced Operations
Knowledge of process validation (VP, IQ, OQ, PQ) and associated documentation
Experience conducting Gauge R&R studies for products and new processes
Application and development of statistical tools for continuous improvement projects
Management of non-conformities (NC) and Corrective/Preventive Actions (CAPA) with QA
Proficiency in Six-Sigma tools for process improvement and problem-solving
Technical leadership on product and process issues
Experience leading technical improvements under Continuous Improvement Program (CIP)
Ability to provide technical leadership/guidance to Process/Maintenance Technicians and other engineers
Project management skills, including scoping, approval, budgeting, specification, execution, qualification, and handover
Experience interfacing with cross-functional teams and 3rd party vendors
Proficiency in quality and regulatory compliance
Ability to undertake Subject Matter Expert roles
Coaching skills for Associate Engineers and Engineers
Project management experience with resource prioritization, time, budget, and quality metrics

Responsibilities

Programming, setup, and making samples of 5-axis tool grinder according to customer drawings
Provide advanced technical and engineering support to projects or functions
Ensure quality of process and product per OS and Material specifications
Ensure GMPs and system safety
Lead PFMEA, Control Plan, SOP, and PPAP generation for product transfers and scale-ups
Support capital acquisition from equipment specification through installation and validation
Provide training for manufacturing team members
Interface with Materials Science, Design, and Quality Assurance to deliver quality products timely
Communicate and participate in system and process troubleshooting with teams and external agents
Lead and participate in cross-functional and cross-divisional process improvement initiatives
Identify, quantify, and implement opportunities to reduce cost of goods
Provide engineering support to Advanced Operations for new product and process introductions
Conduct process validation (VP, IQ, OQ, PQ) and associated documentation
Conduct Gauge R&R studies for products and new processes
Apply and develop statistical tools for continuous improvement projects
Manage non-conformities (NC) and CAPA with QA departments
Assist in developing global teams proficient in process improvement and problem-solving using Six-Sigma tools
Provide technical leadership on all product and process issues
Lead technical improvements under the Continuous Improvement Program (CIP)
Provide technical leadership/guidance to Process/Maintenance Technicians and other Manufacturing/Equipment Engineers
Manage assigned projects (value stream and cross-functional), including scoping, approval, budgeting, specification, execution, qualification, and handover
Actively interface with cross-functional teams and 3rd party vendors, practicing good teamwork for operations and business targets
Foster a continuous improvement work environment supporting quality policy, system, and regulations, ensuring employee training and documentation
Undertake project management, resource prioritization, and execution of project plans (time, budget, quality metrics)
Demonstrate proficiency in quality and regulatory compliance
Coach Associate Engineers and Engineers in their development

Skills

Key technologies and capabilities for this role

5-Axis CNC ProgrammingPFMEAControl PlanSOPPPAPProcess ValidationIQOQPQGauge R&RGMPStatistical Tools

Questions & Answers

Common questions about this position

Is this position remote or onsite?

The position requires onsite work with no remote flexibility mentioned.

What are the key technical skills required for this role?

Key skills include programming and setup of 5-axis tool grinders, process validation (VP, IQ, OQ, PQ), PFMEA, Control Plan, SOP, PPAP, statistical tools, Six-Sigma, and Gauge R&R studies.

What leadership responsibilities does this role involve?

The role includes leading PFMEA, Control Plan, SOP, PPAP, cross-functional process improvements, technical leadership on product/process issues, training manufacturing teams, and managing projects from scoping to handover.

What is the company culture or team environment like?

The role involves working in a cross-functional, global team environment focused on continuous improvement using Six-Sigma tools, process enhancements under the Continuous Improvement Program (CIP), and collaboration with departments like Materials Science, Design, and Quality Assurance.

What makes a strong candidate for this Manufacturing Engineer position?

Strong candidates will have advanced engineering competencies, systems training for manufacturing support, experience with 5-axis programming, process validation, Six-Sigma, and proven ability to lead cross-functional projects and provide technical 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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