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Sr. R&D Engineer

2 months ago

St Petersburg, United States Medix™ Full time

Job Summary: The Senior R&D Engineer plays a key role in driving new product development initiatives while evaluating and enhancing existing products across multiple product lines. This role ensures that products meet functional requirements, quality standards, and customer needs in terms of usability and performance.

Key Responsibilities:

  • Product Design and Development: Lead the design and development of new products for internal and external manufacturing sites within the corporate group.
  • Research and Testing: Conduct research, testing, and analysis of new and existing products. Implement material, design, and process changes to improve quality and reduce cycle times. Address defects through design control processes.
  • Product Support: Provide ongoing support for manufacturing, sales, and quality teams related to design specifications, customer requirements, testing, CAPA, and product documentation.
  • Engineering Leadership: Lead new product engineering efforts, design analysis, and technical reviews across departments. Apply industry best practices and engineering methodologies to solve complex problems.
  • Manufacturing Collaboration: Work closely with manufacturing teams during design stages to ensure products are optimized for efficient and cost-effective production.
  • Compliance and Quality Assurance: Ensure all products comply with ISO13485 standards, FDA regulations, and Good Manufacturing Practices. Lead the application of FMEA and other risk assessment methodologies.
  • Team Mentorship: Mentor junior engineers in key areas like FMEA, design validation, and material/component specification, fostering professional growth.
  • Prototyping and Testing: Develop and execute test plans, perform design adjustments, and oversee prototype approvals, ensuring products meet performance and quality standards.
  • Technical Documentation: Create and maintain product literature by interpreting and recording technical data and performance results.
  • Project Management: Manage projects from concept through production, ensuring accurate schedules and budgets are maintained.

Additional Responsibilities:

  • Collaborate with cross-functional teams (engineering, manufacturing, sales/marketing) to develop detailed project plans.
  • Contribute to continuous improvement initiatives within a LEAN manufacturing environment.

Required Skills and Competencies:

  • Proficiency in standard computer applications (MS Word, Excel, Outlook, PowerPoint).
  • Strong communication skills with the ability to engage both internal and external stakeholders.
  • Ability to work collaboratively in a team environment, demonstrating mutual respect and accountability.
  • Attention to detail and accuracy in all tasks.
  • Effective decision-making and problem-solving skills.
  • Capability to teach, coach, and guide colleagues, promoting knowledge sharing.
  • Flexibility to adapt to changes, manage competing demands, and handle unexpected events.
  • Commitment to maintaining confidentiality and discretion.

Education and Experience:

  • Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline (Master’s or PhD preferred).
  • Experience in design and development within the medical device or component industry.
  • Expertise in high-volume manufacturing, especially with plastic injection molding.
  • Hands-on experience with Design Control, including design and process verification and validation.
  • Experience with Phase-Gate development processes and designing production-equivalent rapid prototypes.
  • Proficient in statistical methods and Six Sigma tools for quality and process control.
  • Extensive knowledge of applied mechanical engineering principles for product design and evaluation.
  • Strong aptitude for hands-on testing and experimentation in a lab environment.
  • Proficiency in 3D CAD software (SolidWorks preferred) and familiarity with CAE tools like FEA and CFD.