Project Leader, Engineering at Stryker

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

Bachelor's degree or above in Mechanical Engineering, Manufacturing Engineering, Materials Engineering, or related fields
≥5 years of experience in precision manufacturing industry; ≥3 years of project management experience; medical device industry background preferred
Proficiency in project management methodologies, cross-functional coordination, and tools (MS Project, Excel Gantt, etc.)
Expertise in GD&T and at least two of Milling, Turning, Mill-Turn, Swiss-Turning, 5-axis Grinding precision machining processes
Familiarity with medical device common metal materials (stainless steel, titanium alloy, etc.) selection, and tooling/fixture design and evaluation capabilities
Knowledge of precision parts post-processing and surface treatment processes (e.g., electroplating (nickel, chrome), mechanical polishing, electropolishing, passivation, sandblasting, laser marking, laser welding, automated painting/coating, ultrasonic cleaning), including impacts on appearance, functionality, biocompatibility, and regulatory compliance; basic process route design and problem analysis
Familiarity with ISO13485, FDA QSR, NMPA registration processes, and validation processes (IQ/OQ/PQ)
Fluent in Chinese and English; ability to host international project meetings, write reports, and communicate with clients
Proficiency in CAD, SolidWorks, Office suite; familiarity with ERP/M systems
Plus points: PMP certification, Six Sigma Green/Black Belt, ISO13485 internal auditor qualifications

Responsibilities

Full lifecycle project management: Lead end-to-end advancement of projects (PT, NPI, Prototype, etc.), from initiation, process evaluation, sample delivery, validation, to mass production; formulate and maintain project plans (MS Project/Gantt charts) to ensure key milestones and deliverables; host regular project meetings to track progress, identify risks, and solve issues; organize phase reviews (e.g., Issue Log reviews, process confirmation, FAI submission, validation approval); manage physical and document outputs across project stages
Cross-departmental coordination and resource integration: Collaborate with process, manufacturing, quality, procurement, supply chain to build efficient project teams; responsible for task decomposition and allocation to ensure internal/external resources are in place; track resource usage and budget execution, identify bottlenecks, and proactively resolve
Customer interface: Serve as Suzhou factory's external technical window at project level, handling customer coordination, communication, and key issue feedback; manage customer change requests (ECR/ECN), organize internal rapid response and risk assessment; assist with DFM reviews, quotation confirmations, and issue tracking closure; follow up on customer changes and provide timely factory evaluation feedback
Project status reporting: Regularly produce project reports to update management and customers on status, risks, and plan adjustments; lead monthly/quarterly project review meetings; support internal/external audits and inspections
Process route planning: Collaborate closely with ME team to analyze customer drawings and product technical needs, lead formulation of product process routes (core processes, key operations, preliminary fixture selection, initial machining capability assessment)
DFX (Design for Excellence) analysis and suggestions: Lead DFX analysis (manufacturability, assemblability, testability, reliability, cost); collaborate with engineering, quality, supply chain to propose and drive multi-dimensional optimizations to improve product performance, reduce lifecycle costs, shorten development time, and match design with production capabilities
Production resources and cost estimation: Lead process evaluation for internal quotations, assess new product/process resource matching; collaborate with manufacturing engineering, planning, procurement, finance to calculate capacity, equipment/tooling needs, manufacturing challenges, cycle times, and direct costs for decision-making data
Process development management: Organize process optimization and validation per project Gate Control goals; coordinate resources and tasks for sample delivery quality, timelines, and documentation; assist in preparing validation materials (IQ/OQ/PQ), track validation, support customer/internal audits; lead problem analysis and review meetings for quality/process issues
Mass production transfer and continuous optimization: Drive process confirmation pre-transfer, compilation and activation of WI/SOP documents; implement improvement measures, track effects for closure, and formalize documents
Regulatory and compliance support: Familiar with ISO13485, FDA QSR, EU MDR; ensure compliance in design transfer and production validation; assist with technical inquiries and corrective actions in internal/external audits
External supply chain process support: Participate in key outsourced parts process discussions, prototyping, and validation; support procurement in technical evaluations, capability confirmation, and supplier development

Skills

Project Management

MS Project

Gantt Charts

DFX

DFM

ISO13485

FDA QSR

EU MDR

IQ/OQ/PQ

ECR/ECN

FAI

Cross-functional Coordination

Risk Management

Process Optimization

Precision Manufacturing

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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