Senior Development Engineer

Senior Development Engineer

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Development Engineer based in the United States.

The Senior Development Engineer will lead the design, development, and testing of innovative medical devices, surgical instruments, and orthopedic components. This role oversees the entire product development lifecycle, from initial concept and engineering design through validation and production. You will collaborate closely with surgeons, customers, suppliers, and multidisciplinary teams to transform clinical needs into effective product solutions. Combining advanced engineering expertise with practical project leadership, you will ensure products meet technical, quality, safety, and regulatory requirements. You will also manage project resources, guide team members, and contribute to strategic technical decisions that influence product development outcomes. This is an opportunity to contribute to meaningful medical innovations in a collaborative, fast-paced environment focused on improving surgical solutions and patient care.

Accountabilities

As Senior Development Engineer, you will lead complex medical product development initiatives, coordinate cross-functional activities, and ensure successful delivery from concept to production.

• Manage product development projects from initial concept through production, ensuring timelines, deliverables, and technical objectives are achieved.
• Engage regularly with surgeon customers to understand clinical needs, identify product improvements, and explore new surgical instrument concepts.
• Coordinate cross-functional teams to maintain technical alignment, encourage collaboration, and support effective project execution.
• Develop project plans, assign responsibilities, monitor team progress, and review deliverables to ensure high-quality outcomes.
• Manage project budgets, oversee expenditures, and allocate financial resources efficiently.
• Develop regulatory clearance strategies and plans for review and approval by the team lead.
• Maintain accurate technical documentation for regulatory submissions and quality management systems.
• Lead the design and engineering development of medical and surgical components, equipment, instruments, and related products.
• Make informed engineering decisions and evaluate design trade-offs within assigned technical areas.
• Create, modify, and maintain detailed CAD models, engineering designs, and technical drawings.
• Prepare and deliver complex product prototypes and components to external testing laboratories.
• Plan and conduct product testing to evaluate performance, safety, functionality, and compliance with applicable requirements.
• Troubleshoot technical issues identified during testing and develop effective corrective solutions.
• Assess unfavorable or questionable test results, communicate potential impacts, and recommend appropriate next steps.
• Build and maintain strong working relationships with surgeons, clients, suppliers, and other key stakeholders.
• Gather and incorporate stakeholder feedback throughout the design and development process.
• Participate in continuous improvement initiatives to enhance product quality, engineering practices, and development processes.
• Provide technical guidance and contribute to engineering decisions that affect other teams and broader organizational objectives.

Requirements

The ideal candidate combines substantial medical device engineering experience with strong project management capabilities, technical problem-solving skills, and a user-centered approach to product development.

• Bachelor's degree in Engineering or a related discipline required; an advanced degree is preferred.
• At least 7 years of experience in medical product development, particularly within orthopedics, or a closely related field.
• Demonstrated experience in medical device design and product development is essential.
• Strong understanding of the medical device industry and its technical and regulatory requirements.
• Experience with Design Controls and Risk Management is preferred.
• Ability to understand and empathize with end users, including surgeons, surgical technologists, and sales representatives, and translate their needs into effective product designs.
• Strong project management skills, including the ability to coordinate teams, manage timelines, allocate resources, and oversee budgets.
• Technical proficiency in CAD modeling, engineering design, and the preparation of detailed technical drawings.
• Ability to evaluate product performance, interpret test results, troubleshoot technical challenges, and recommend appropriate solutions.
• Strong written communication skills, including the ability to prepare post-training reports, document project outcomes, and provide clear performance metrics and feedback.
• Excellent attention to detail, with a commitment to product quality, safety, and regulatory compliance.
• Ability to work independently while collaborating effectively with multidisciplinary teams.
• Strong interpersonal skills and the ability to communicate technical concepts and influence engineering decisions across different functions.

Benefits

• Competitive salary and compensation package.
• Bonus program.
• Employee benefits package.
• Collaborative and supportive workplace culture.
• Opportunities for professional development and career advancement.
• Opportunity to contribute to innovative medical device and orthopedic product development projects.
• Exposure to experienced professionals and multidisciplinary teams within the medical technology industry.
• Opportunity to make meaningful contributions to products designed to improve surgical procedures and patient outcomes.