Orthopedic MedTech R&D Manager — Lead & Scale Devices

BioTalent Ltd; San Diego (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

BioTalent Ltd. seeks an experienced R&D Manager to lead design and development of orthopedic and powered surgical medical devices from concept through commercialization.

You will provide technical, functional, and people leadership to an engineering team, coordinating with Manufacturing, Quality, Regulatory, and Supply Chain to deliver safe, reliable products through robust development programs and DFMA principles.

Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related field required; advanced engineering degree a plus.
• 7+ years of relevant industry experience in product design and development (5-10 years as a Design Engineer within medical devices)
• Experience in regulated environments (medical devices) with working knowledge of DHF/Design Controls and risk management

Responsibilities

• Lead design and development activities from customer requirements through proof of concept, verification/validation, and commercialization
• Provide technical leadership and direction to engineers and designers, including mentoring, work prioritization, and performance guidance
• Own product development programs, including timelines, deliverables, and cross-functional alignment with Manufacturing, QA/RA, Supply Chain, and Business Development
• Ensure compliance with design control requirements, including Design History Files (DHF) and Technical Files; review and approve engineering designs, drawings, specifications, and test protocols
• Drive Design for Manufacturability, Inspection, and Assembly (DFMIA) to support efficient, scalable production
• Evaluate and resolve complex design and process issues impacting product performance, manufacturing, inspection, or assembly
• Lead tolerance analysis, risk assessments, and design reviews
• Collaborate with internal teams and external suppliers to support development, troubleshoot issues, and optimize designs
• Oversee verification and validation activities, including test method, protocol, and report development
• Gather and analyze data related to manufacturing processes, costs, materials, and methods to support decision-making
• Participate in or lead customer interactions related to product development initiatives
• Lead or participate in continuous improvement initiatives related to engineering processes and product development

Skills

Leadership

Design controls

DHF & Technical Files

Regulatory knowledge (ISO 13485, IEC 6

SolidWorks

DFMIA

Tolerance analysis

GD&T

Data-driven decision making

Cross-functional collaboration

Education

Bachelors in Mechanical or Electrical Engineering

Advanced engineering degree a plus

Tools

SolidWorks

Job description

BioTalent Ltd. seeks an experienced R&D Manager to lead design and development of orthopedic and powered surgical medical devices from concept through commercialization.

You will provide technical, functional, and people leadership to an engineering team, coordinating with Manufacturing, Quality, Regulatory, and Supply Chain to deliver safe, reliable products through robust development programs and DFMA principles.