Senior Product Development Eng

Orlando HealthOrlando, FL
14hOnsite

About The Position

At Orlando Health, we are ordinary people with extraordinary individuality, working together to bring help, healing and hope to those we serve. By daily embodying our over 100-year legacy, we reinforce our reputation as a trusted and respected healthcare organization that delivers professional and compassionate care to our patients, families and communities. Through our award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities, our 27,000+ team members serve communities that span Florida’s east to west coasts and beyond. Leads the technical development of innovative medical devices from concept through commercialization. The role requires strong mechanical design expertise, engineering fundamentals, and experience across the full product development lifecycle within the medical device industry. This position collaborates closely with cross-functional teams, including Research, Quality, Regulatory, and Contract Manufacturing.

Requirements

  • Bachelor’s degree in Mechanical Engineering or a related discipline (Master’s degree preferred).
  • Strong understanding of material science, mechanics, thermodynamics, and fluid dynamics.
  • Familiarity with design for manufacturability and assembly (DFM/DFA).
  • Working knowledge of sterilization, biocompatibility, and packaging requirements.
  • Familiarity with simulation tools (FEA, CFD) and tolerance stack-up analysis.
  • Seven (7) years of relevant experience in mechanical engineering, with at least five (5) years in medical device development.
  • Proven experience with medical device product development processes under FDA 21 CFR Part 820 and ISO 13485.
  • Proficiency in 3D CAD and PDM systems (SolidWorks preferred).
  • Hands-on experience with rapid prototyping, testing, and design iteration.
  • Experience with design and development of implantable or interventional medical devices.
  • Experience in a regulated product environment with both U.S. and international market focus.

Nice To Haves

  • Six Sigma or Design for Six Sigma (DFSS) certification is a plus.

Responsibilities

  • Serves as technical Lead for mechanical design efforts for Class I and II medical devices in accordance with ISO 13485 and FDA regulations.
  • Develops and validates mechanical components and assemblies, ensuring performance, safety, and reliability requirements are met.
  • Owns and drives design control documentation, including DHF elements (design inputs, outputs, verification, validation, risk management, etc.).
  • Utilizes CAD tools (e.g., SolidWorks, Creo) for modeling, prototyping, and detailed mechanical drawings compliant with GD and T.
  • Collaborates with suppliers and contract manufacturers for DFM/DFA, tooling, and production scale-up.
  • Supports root cause analysis and CAPA activities as needed during development and post-market phases.
  • Mentors junior engineers and provides technical leadership within project teams.
  • Drives innovation through identification of new materials, manufacturing methods, and design techniques.
  • Works cross-functionally to ensure successful project execution aligned with clinical and business objectives.
  • Presents technical findings, reports, and project updates to internal stakeholders and external partners.
  • Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.
  • Maintains compliance with all Orlando Health policies and procedures.
  • Demonstrates excellent problem-solving, analytical, and communication skills.
  • Leads engineering efforts and manages technical risks.

Benefits

  • All Inclusive Benefits (start day one)
  • Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees.
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