Senior Design Engineer

2 months ago

Flowood, Mississippi, United States Zavation Medical Products Full time
Job Title: Senior Design Engineer

At Zavation Medical Products, we are seeking a highly skilled Senior Design Engineer to lead the design and development of complex medical devices. As a key member of our team, you will be responsible for managing major product development projects from concept to launch, providing technical leadership to cross-functional teams, and ensuring compliance with industry standards and regulatory requirements.

Key Responsibilities:
  • Lead the design and development of new products, specialty, and custom products, and sustaining engineering work.
  • Take ownership of the design process, including concept generation, detailed design, prototyping, and testing.
  • Develop detailed engineering drawings and 3D models using CAD software, applying GD&T (Geometrical Dimensioning and Tolerancing) and DFM (Design for Manufacturability) principles.
  • Collaborate with manufacturing, quality, regulatory, and other departments to ensure designs are manufacturable, cost-effective, and compliant with relevant standards.
  • Lead major new product development projects, managing the entire project lifecycle from concept to market launch.
  • Develop and manage project plans, timelines, budgets, and key deliverables.
  • Coordinate cross-functional team activities and ensure effective communication across all stakeholders.
  • Participate in the budget planning cycle for assigned projects and provide input on resource allocation.
  • Provide technical supervision, coaching, and mentoring to less senior engineers and technical personnel.
  • Review the work of colleagues, junior engineers, and technical personnel for accuracy, completeness, and innovation.
  • Offer guidance and direction for design improvements, simplification, and enhanced innovation.
  • Engage with Marketing and Sales teams to define customer needs and translate them into product design requirements.
  • Work closely with surgeons and key opinion leaders (KOLs) throughout the conceptualization and development phases.
  • Lead development sessions and actively participate in cadaver labs with surgeons to obtain critical project input.
  • Lead risk management activities, including dFMEA and pFMEA, to identify and mitigate potential design risks.
  • Oversee design verification and validation activities, including mechanical testing, design of experiments, and design transfer.
  • Ensure that all design activities comply with GMP, the company's design control procedures, and the quality management system.
  • Support regulatory submissions, such as 510(k) filings, from a technical standpoint.
  • Lead the cleaning, packaging, and sterilization validation activities, and manage the development of instrument trays and BOM.
  • Participate in Material Review Board (MRB) activities and assist Quality/Regulatory teams in reviewing complaints and nonconformances.
  • Contribute to the development of the company's intellectual property portfolio by generating novel ideas and innovations.
  • Support Freedom to Operate (FTO) assessments and conduct competitive landscape evaluations to guide product development.
Qualifications:
  • Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or a related field required.
  • Minimum of 7-10 years of hands-on product development experience in a regulated industry.
  • Proven track record of leading complex product development projects and successfully bringing products to market.
  • Extensive experience with design control processes, and regulatory compliance.
  • Strong mechanical design aptitude and problem-solving skills.
  • Proficiency in CAD software (e.g., SolidWorks) and experience with FEA (Finite Element Analysis).
  • In-depth knowledge of manufacturing processes, including milling, turning, wire-EDM, welding, and additive manufacturing.
  • Strong leadership skills, with the ability to mentor and guide junior engineers.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, customers, and external partners.
  • Ability to manage multiple projects simultaneously and meet deadlines.
  • Experience with Intellectual Property, including patents, trademarks, and trade secrets, is highly desirable.

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