R&D Manager

R&D Manager

The R&D Manager leads the design and development of orthopedic and powered surgical medical devices from concept through commercialization while providing technical, functional, and people leadership to an engineering team. This role is responsible for driving cross-functional product development activities with Manufacturing, Quality, Regulatory, Supply Chain, and Business Development, ensuring compliance with design controls, manufacturability, and regulatory requirements while optimizing product performance, reliability, cost, and scalability.

Ideal candidates have hands-on experience developing powered electromechanical surgical devices such as surgical handpieces, drills, drivers, reamers, saws, robotic end effectors, or similar orthopedic instrumentation. This individual will have a proven track record leading engineering teams, managing complex product development programs, and bringing medical devices from concept through commercialization in a regulated environment.

Job duties include:

• Leading and managing design and development activities from customer requirements through proof of concept, verification/validation, and commercialization.
• Providing technical leadership and direction to engineers and designers, including mentoring, prioritization of work, and performance guidance.
• Owning product development programs, including timelines, deliverables, and cross-functional alignment with Manufacturing, QA/RA, Supply Chain, and Business Development.
• Ensuring compliance with design control requirements, including development and maintenance of Design History Files (DHF) and Technical Files. Reviewing and approving engineering designs, drawings, specifications, and test protocols to ensure accuracy, completeness, and adherence to standards.
• Driving Design for Manufacturability, Inspection, and Assembly (DFMIA) to ensure efficient and scalable production processes.
• Evaluating and resolving complex design and process issues that impact product performance, manufacturing, inspection, or assembly.
• Leading tolerance analysis, risk assessments, and design reviews to support robust product development.
• Collaborating with internal teams and external suppliers to support development efforts, troubleshoot issues, and optimize designs. Providing technical support to Management, Manufacturing, Quality, Regulatory, and Purchasing as needed.
• Overseeing verification and validation activities, including development of test methods, protocols, and reports. Gathering and analyzing data related to manufacturing processes, costs, materials, and methods to support decision making. Participating in or leading customer interactions related to product development initiatives.
• Ensuring adherence to company policies, procedures, and regulatory requirements. Leading or participating in continuous improvement initiatives related to engineering processes and product development.
• Performing other duties as assigned.

Skills and qualifications include:

• Bachelor's Degree in Mechanical Engineering, Electrical Engineering, or related field required.
• Minimum of 7+ years of relevant industry experience, including product design and development.
• Prior experience in a leadership or supervisory capacity strongly preferred.
• Experience in regulated industries required, preferably medical device, with working knowledge of IEC 60601-x, ISO 13485, and FDA 21 CFR Part 820.
• Strong experience with design controls and Design History File (DHF) requirements. Experience with Risk Management (ISO 14971) preferred. Proficiency in 3D CAD software (SolidWorks preferred).
• Strong background in electromechanical product design and development. Experience with CNC machining and manufacturing processes preferred.
• Strong understanding of Design for Manufacturability, Inspection, and Assembly (DFMIA).
• Advanced knowledge of ASME Y14.5 GD&T and engineering drawing standards. Ability to perform tolerance stack-up analysis.
• Strong analytical and problem-solving skills with a data-driven approach.

Accountabilities include:

• Providing leadership, direction, and accountability for design and development team performance.
• Owning outcomes of product development programs, including quality, timelines, and deliverables.
• Exercising independent judgment and initiative in technical and managerial decision making.
• Ensuring compliance with all regulatory, quality, and company standards.
• Promoting best practices, continuous improvement, and engineering excellence.
• Maintaining a safe working environment.
• Hands-on leadership approach to problem solving and execution.
• Expected to provide additional effort as needed to meet critical deadlines and business objectives.

Education and experience: Bachelor's degree in engineering (mechanical, electrical, or equivalent) 5-10 years' experience as a Design Engineer within medical device industry. Advanced engineering degree a plus.

Mental, physical, and visual demands: While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type, and move throughout the facility and must be capable of using a keyboard for computer purposes. This role may require the employee to periodically lift and/or move up to 50 pounds. The employee may be required to conduct inspections under magnification.

We are an Equal Employment Opportunity ("EEO") Employer. We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. The Company makes hiring decisions based solely on qualifications, merit, and business needs at the time.