Senior Design & Development Quality Engineer – Sports Medicine

Location: Sarasota, FL

Summary of Primary Responsibilities:

This position is a key decision-maker and subject matter expert in design control, risk management, and human factors/usability engineering of medical devices.  The individual in this role will also drive continuous improvement in design documentation to ensure compliance with regulatory requirements and state of the art standards.  This individual will collaborate and partner with R&D Engineering, Regulatory, Clinical, Marketing, and Manufacturing to achieve optimal results.

Specific Responsibilities:

  • Provides quality engineering expertise participating on cross-functional design and development teams.
  • Achieves design and development deliverables using a Stage-Gate process.
  • Establishes design development plans (DDPs) identifying critical-to-quality and performance and safety product attributes during each design phase.
  • Key stakeholder in preparing risk management documentation that complies with ISO 14971 requirements.  
  • Provides guidance and quality oversight in all design activities, including validation and verification.
  • Assists in post market product sustaining activities, such as design changes, customer complaint investigations, and CAPAs.
  • Conducts gap analyses for new/updated regulations and standards; develops plans and implements actions to ensure continued compliance for product design and the quality management system.
  • Supports internal and external regulatory audits
  • Performs other related duties as assigned

Job Complexity:

Work involves completion of tasks of varying complexity within a defined period using a combination of agile and waterfall methodologies. Time and resources allocated for proof of concept may be constrained.  Identifying potential hazards and risk mitigation activities may be tedious.  Delivering clear and concise messaging, exercising sound judgement, and utilizing established methods and techniques in work activities will increase productivity and limit stress. 

Supervisor Responsibilities:

This position will be a key contributor on design and development teams.  No direct reports. 

Experience, Knowledge and Skills Required:

  • Bachelor’s degree in biomedical or mechanical engineering or related discipline; Master’s Degree preferred
  • Minimum of 5 years of medical device product development experience
  • Prior design experience for implantable orthopedic devices and instrumentation (Class Ir, IIa, IIb and III), highly desirable.
  • Requires knowledge of human anatomy and physiology and a fundamental understanding of orthopedic surgical practices and techniques
  • Experience working on teams and promoting critical thinking
  • Working knowledge of scientific principles related to product development and design controls
  • Proven competency in preparing risk management documentation compliant to ISO 14971
  • Ability to interpret and apply US and international regulations and standards including 21CFR Part 820, ISO 13485, and EU MDR
  • Proficiency in Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Teams)
  • Experience with statistics and statical analytics tools (e.g., Minitab)
  • Strong written and verbal communication skills
  • Keen attention to detail
  • Experience in delivering presentations on complex quality-related issues and topics
  • Six Sigma certification a plus
  • Ability to travel up to 10-15%

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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