**Requisition ID** 12612BR
**Job Title** Sr. Engineer, Advanced Quality
**Group** Orthopaedics
**Division** Reconstructive
**Business Unit** RCNCQR
**Business Function** Research and Development
**Country** United States
**State/Province** FL
**City** Fort Lauderdale
**Employment Category** Full Time
**Percent Travel Required** Up to 10%
**Shift** 1st
**About Stryker**
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
**Job Description / Information**
Lead Quality Engineering activities in the development of orthopedic products to ensure the highest level of product and process quality. Also provide guidance to the New Product Development teams to ensure compliance to the company’s quality system and external standards.
•Participate in design, development, manufacturing and risk management activities of tied to high-volume product launches
•Participate in the evaluation of overall residual risk for products prior to launch and present final risk-benefit justification to executive leadership
•Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation and manufacturing process mitigate of those issues throughout the development process
•Support Product Development in the definition of design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
•Support Advanced Operations in the development of manufacturing processes for new products
•Develop, review and approve inspection plans, routers and product drawings
•Support product design transfers to internal and/or external manufacturing facilities
•Evaluate product design changes for verification and validation requirements and assist in change implementation.
•Develop quality assurance documentation to support regulatory submissions
•Work with complaint investigators to complete post-market health risk assessments
•Support quality system maintenance primarily for the design control process by identifying and correcting deficiencies in our procedures and practices
•Manage, lead and/or assist in resolving nonconformities and corrective/preventive actions (CAPA)
Implant-Specific Essential Duties and Responsibilities:
•Support design, development and manufacturing of low volume customer-specific instruments and implants
•Lead Risk Management activities for low volume customer-specific instruments and implants
Robotic-Specific Essential Duties and Responsibilities:
•Support design, development and manufacturing of robotic systems, software and instruments.
•Develops Quality Assurance Plans for new products.
•Lead risk management activities for robotics by developing risk management plans/reports, conducting risk reviews, verifying implementation and effectiveness of risk controls and driving post market activities.
•Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria. Promote efficient testing practices.
•Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary.
•Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
•Identify supplier assessment requirements and communicate these to the supplier quality group.
**Minimum Qualifications**
•Bachelor’s degree in Mechanical Engineering or related field of study. Prefer CQE certification and Six Sigma Green or Black Belt.
•3+ years of experience as a Quality Engineer (QE) in a regulated design environment. Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation
•Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
•Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), Root Cause Analysis, and Mistake Proofing/Poka Yoke.
•Demonstrated ability to read CAD drawings and interpretation of GD&T
•Demonstrated ability to advocate product excellence and quality
•Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
•Demonstrated problem-solving and troubleshooting skills.
•Demonstrated interpersonal and communication skills.
•Demonstrated a positive, energetic approach to teamwork.
•Demonstrated ability to learn quickly and multi-task
•Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
•Computer proficiency with Mini-tab or similar analysis program, Visio, MS Office.
All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
Stryker is an EO employer – M/F/Veteran/Disability