Senior Software Quality Engineer - Design Assurance (Hybrid)

    • Stryker
  • Weston, FL
  • Posted 34 days ago | Updated 4 hours ago

Overview

On Site
Full Time

Skills

Recruiting
Engineering design
Regulatory Compliance
Work ethic
Partnership
Collaboration
Manufacturing
Quality assurance
Leadership
Robotics
Testing
Statistics
Product design
Software development methodology
Computer science
Six Sigma
Medical devices
Risk management
Design
Verification and validation
FDA
ISO 13485
Design controls
ISO 9000
FMEA
GD&T
Root cause analysis
Operations
Product development
Marketing
Problem solving
Communication
Teamwork
Multitasking
Microsoft Visio

Job Details

Stryker is hiring Senior Software Quality Engineer - Design Assurance (Hybrid) to join our Joint Replacement division in Weston, Florida to help lead Quality Engineering activities in the development of robotically assisted surgical systems 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.

Workplace Flexibility: Candidate must reside within a commutable distance to Weston, Florida but is expected to be onsite at the facility multiple times/week.

Who we want-
  • Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
  • Challengers & Influencers. People who constantly challenge themselves and each other to achieve more & to win the right way.
  • Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.


What you will do:
  • 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.
  • Evaluate product design changes for verification and validation requirements and assist in change implementation.


What you will need

Required:
  • Bachelor's degree in engineering
  • Minimum 3+ years of experience as a Quality Engineer (QE) in a regulated design environment while working in a highly regulated industry in product development life cycle, including risk management and design/process verification & validation with some foundational knowledge of software and SDLC.

Preferred:
  • Bachelor's Degree in Computer Science or related field of study strongly preferred
  • Prefer CQE certification and Six Sigma Green or Black Belt.
  • Knowledge of medical device product development life cycle, including risk management and design/ process verification & validation and computer software 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), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
  • Demonstrated ability to read and interpret CAD drawings
  • 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.
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