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Director of Product Development Engineering – Adult Reconstruction – 3705659

Join a growing and innovation-focused orthopedic medical device company seeking a Director of Product Development Engineering to lead the design, development, and lifecycle management of cutting-edge implant and instrumentation technologies within the Adult Reconstruction market. This highly visible leadership role will be responsible for driving new product innovation, sustaining engineering initiatives, surgeon collaboration, and engineering team development while partnering cross-functionally with Marketing, Quality, Regulatory, Operations, and Executive Leadership. The ideal candidate is a proven orthopedic product development leader with experience in Hip or Knee Reconstruction who enjoys building teams, mentoring engineers, and bringing innovative technologies from concept through commercialization.

Responsibilities:

·        Lead and develop a team of product development engineers, providing technical direction, coaching, performance management, and succession planning.

·        Drive the development of orthopedic implant and instrument systems through all phases of the product lifecycle, from concept and surgeon collaboration through launch and post-market support.

·        Partner with surgeon design teams and cross-functional stakeholders to identify unmet clinical needs and develop innovative product solutions.

·        Oversee project planning, resource allocation, timelines, budgets, risk management, and execution for multiple product development programs.

·        Provide leadership for sustaining engineering activities, product enhancements, and design transfer initiatives.

·        Ensure compliance with design controls, quality system requirements, regulatory standards, and global product development processes.

·        Work closely with Quality and Regulatory teams to support submissions, technical documentation, design history files, validation activities, and MDR requirements.

·        Lead cross-functional teams consisting of engineering, marketing, manufacturing, operations, quality, regulatory, surgeons, and external development partners.

·        Evaluate emerging technologies, materials, and development opportunities to support future portfolio growth and innovation.

·        Contribute to long-range product strategy, organizational planning, and engineering best practices to support business objectives.

Qualifications:

·        10+ years of medical device product development experience with a strong preference for orthopedic implant systems.

·        5+ years of leadership experience with direct people management responsibility. Candidates currently at the Senior Manager level with proven leadership experience will be considered.

·        Experience with Hip Reconstruction or Knee Reconstruction is strongly preferred.

·        Experience within Extremities may be considered; Spine and Sports Medicine experience are lower priorities.

·        Demonstrated success leading product development projects through concept, verification, validation, regulatory approval, and commercialization.

·        Experience collaborating directly with surgeon design teams and physician advisors throughout the development process.

·        Strong understanding of design controls, design transfer, sustaining engineering, risk management, and regulatory requirements.

·        Experience supporting European MDR and other global regulatory processes is highly desirable.

·        Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline required; Master’s degree preferred.

Compensation:

• Base Salary: Competitive
• Comprehensive Benefits Package
• Location: Florida (on-site)

The job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as needed to support the organization.

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