Senior Design Engineer

The Design Engineer III, or Senior Design Engineer, is responsible for leading the design and development of complex medical devices, with a focus on spinal implants and instruments.

This role involves 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.

The Senior Design Engineer plays a critical role in innovation, process improvement, and mentoring junior engineers. 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. Powered by JazzHR