Director of Engineering

Hands-on Medical Device Director who also leads other engineers in the design, development, and improvement of medical devices, while ensuring compliance with relevant regulations and achieving project goals.

Key Responsibilities:

• Team Leadership: Lead, mentor, and managing engineers, fostering a collaborative and innovative environment.
• Project Management: Oversee the product development lifecycle from concept to commercialization, including planning, scheduling, budgeting, and risk management.
• Design & Development: Handson design, prototyping, testing, and validation of medical devices, with adherence to design controls and quality standards.
• Regulatory Compliance: Ensure all design and development activities comply with FDA, ISO, and other relevant regulatory standards.
• CrossFunctional Collaboration: Work closely with other departments, quality assurance, regulatory affairs, manufacturing, and marketing to ensure successful product launches.
• Innovation & Technical Expertise: Troubleshoot technical challenges (design, performance and functional) and stay abreast of new technologies and best practices.
• Documentation: Preparation of detailed design documentation, design history files, risk management files, verification/validation protocols, and reports to support regulatory submissions.
• Plan and coordinate testing, operation, and maintenance of production equipment.
• Evaluate impact of changes on processes, finished product.
• Perform verification and validation activities.
• Development of product specifications and test fixtures.
• Work with QA on applicable biological evaluations and regulatory submissions.
  
  

Qualifications:

• Education: Bachelor’s or Master’s degree in engineering (e.g., biomedical, mechanical, or a related field).
• Experience: Five years of experience in medical device design engineering, with experience in leadership or management role.
• Regulatory Knowledge: Indepth knowledge of FDA regulations (e.g., 21 CFR 820), ISO standards (e.g., ISO 13485, ISO 14971) IEC 623661, and other relevant medical device regulations.
  
  

Key Skills:

• Technical Proficiency: Expertise in engineering fundamentals, CAD software (e.g., SolidWorks), and relevant design and simulation tools.
• Regulatory Expertise: Strong understanding of medical device regulations, design controls, risk management, and quality systems.
• Project Management Skills: Proven ability to manage projects, timelines, budgets, and resources effectively.
• Leadership & Communication: Interpersonal, communication, and leadership skills to motivate and manage, as well as collaborating with internal and external stakeholders.
• ProblemSolving & Creativity: Strong analytical and problemsolving abilities to overcome complex challenges.
• Strong working knowledge with plastic injection molding and associated processes.
  
  

Must be able to travel.

Benefits

401(k) plus matching

Health insurance

Dental insurance

Vision insurance

Employee assistance program

Flexible spending account

Health savings account

Life insurance

Paid time off - 40 hours after 90 days, and 40 hours after six months on year 1.

Schedule: (on-site)

8 hour shifts - Monday to Friday

Ability To Commute

Clearwater, FL 33762 (required)