Stryker

Manufactures orthopedic and surgical medical devices

Senior Engineer - Product Transfer

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeSuzhou, Jiangsu, ChinaNo salary listedIn-person

About the Job

Requirements

A bachelor's degree in an engineering discipline and at least 2 years of experience in a manufacturing or project environment.
A proven track record of working in a team-based environment.
The ability to express ideas and collaborate effectively with multidisciplinary teams, remain open-minded, and recognize good ideas.
The ability to envision new and better ways of doing things.
Experience applying complex problem-solving techniques to manufacturing or design technical issues, with sound judgment for mechanical and structural design.
The ability to read and interpret complex engineering drawings and understand geometric dimensioning and tolerancing.
Experience in an FDA-regulated or other regulated industry.
Experience with process and product validations, statistical methods, process mapping, continuous improvement, and project or process improvement.
Green Belt or Black Belt Six Sigma qualifications.

Responsibilities

Provide engineering support for product transfers and ensure activities are completed and documented in accordance with the latest company procedures.
Determine engineering assignment objectives and make decisions regarding assignment direction and results.
Monitor and control work progress to ensure sound application of engineering principles and appropriate use of policies and procedures.
Analyze equipment to establish operating data, conduct experimental tests and analyze results, and lead or act as an independent reviewer in process review meetings.
Coach and mentor others on functionally related topics.
Ensure process and product quality as defined in applicable operation and material specifications.
Select components and equipment based on specifications, reliability, and regulatory requirements; work with quality engineers to develop component-specific testing and inspection protocols.
Participate in PFMEA, Control Plan, SOP, PPAP, and other internal process qualification generation associated with product transfers.
Ensure adherence to GMP and safety procedures.
Review and approve validation documentation.
Perform other duties as assigned.

Desired Qualifications

Experience in an FDA-regulated or other regulated industry.

Work Flexibility: Onsite

Key Areas of Responsibility

Provide engineering support for product transfers ensuring that all activities are completed and documented in accordance with the latest Stryker procedures.
Determine the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
Monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
Analyse equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
Coach and mentor others on functionally related topics.
Ensure quality of process and product as defined in the appropriate operation and material specifications.
Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
Participate in PFMEA, Control Plan, SOP, PPAP and other Stryker internal process qualification generation associated with product transfers.
Ensure adherence to GMP and safety procedures.
Review and approve of validation documentation.
All other duties as assigned.

Qualifications Knowledge Skills

Bachelors degree in an engineering discipline with 2 or more years’ experience in a manufacturing or project environment
Proven track record of working in a team based environment.
Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.
Innovative thinker - should be able to envisage new and better ways of doing things.
Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
Experience in an FDA regulated or regulated industry
Experience of process/ product validations, statistical methods, Process mapping,
Continuous Improvement and Project / Process Improvement related experience
Green or Black Belt 6 Sigma qualifications
Experience in an FDA regulated or regulated industry beneficial.

Travel Percentage: 20%

About the Company

Stryker

Manufactures orthopedic and surgical medical devices

Stryker makes medical devices for hospitals, surgical centers and emergency responders, spanning joint implants, surgical instruments and patient transport equipment. Its Mako platform assists surgeons with joint replacement, while its neurotechnology products support brain and spine procedures and stroke treatment. Clinicians use its equipment during surgery and emergency care, and the company earns money by selling implants, disposable products and capital equipment through direct sales teams and distributors. The business also supplies training and technical support for healthcare providers using its devices. Stryker was founded in 1941 and is headquartered in Portage, Michigan.

Company size: 10,001+
Company stage: IPO
Headquarters: Portage, MI
Founded: 1941

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