Research & Development Engineer​/Senior Research & Development Engineer

Department: Research & Development (R&D)

Reports To: VP of Scientific Affairs

Location: Memphis, TN (Fixed Hybrid: M-TH onsite; Fri remote)

Title will be commensurate with experience.

We are seeking an experienced and highly motivated Product Development Engineer to lead the design, development, and commercialization of innovative medical devices. The ideal candidate will have 5-10 years of progressive product development experience within the medical device industry and a proven track record of successfully bringing products from concept through commercial launch.

This role requires strong technical leadership, the ability to independently drive complex projects with minimal supervision, and direct engagement with surgeons, customers, suppliers, and cross-functional teams. The successful candidate will possess deep knowledge of design controls, verification and validation activities, manufacturing transfer, and quality system requirements applicable to medical device development.

• Lead product development projects throughout the entire product lifecycle, from concept generation and feasibility through design, verification, validation, manufacturing transfer, and commercialization.
• Independently plan, execute, and deliver complex engineering projects with minimal supervision.
• Translate customer and clinical needs into product requirements, design concepts, and technical solutions.
• Serve as the technical lead on cross-functional development teams, coordinating activities across engineering, quality, regulatory, clinical, operations, and marketing functions.
• Identify project risks and develop mitigation strategies to ensure successful project execution.

• Regularly interact with surgeons, healthcare professionals, and other customers to gather insights, define unmet needs, evaluate concepts, and support product adoption.
• Participate in customer visits, cadaver labs, procedure observations, and product evaluations to drive user-centered product development.
• Present technical updates and design concepts to internal and external stakeholders.

• Lead technical interactions with third-party vendors, development partners, contract manufacturers, and suppliers.
• Define technical requirements and ensure supplier deliverables meet project objectives, timelines, and quality standards.
• Support supplier selection, qualification, and ongoing technical management.

• Develop and review engineering specifications, design documentation, risk analyses, test methods, and protocols.
• Lead design verification and validation activities to demonstrate compliance with user needs, intended use, and regulatory requirements.
• Ensure adherence to design control processes and applicable standards.
• Collaborate with quality and regulatory teams to support submissions and compliance activities.

• Lead manufacturing transfer activities from development into pilot and commercial production.
• Partner with manufacturing teams to optimize product designs for manufacturability, quality, reliability, and cost.
• Resolve technical issues arising during scale-up and production launch.
• Support post-market activities, including product improvements, investigations, and lifecycle management.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related engineering discipline.
• 5-10 years of product development experience
  , preferably within the medical device industry.
• Demonstrated ability to independently lead projects and design activities without regular supervision.
• Proven history of successfully leading and launching medical…