Research & Development Manager

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

R&D Manager — Orthopedic

Summary

We're looking for an R&D Manager to lead the design and development of orthopedic and powered surgical medical devices, from concept through commercialization. You'll provide technical, functional, and people leadership to an engineering team, driving cross-functional product development with Manufacturing, Quality, Regulatory, Supply Chain, and Business Development. This role ensures compliance with design controls, manufacturability, and regulatory requirements while optimizing product performance, reliability, cost, and scalability.

The ideal candidate has hands-on experience developing powered electromechanical surgical devices — surgical handpieces, drills, drivers, reamers, saws, robotic end effectors, or similar orthopedic instrumentation — along with a proven track record leading engineering teams and bringing medical devices to market in a regulated environment.

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

Requirements

• 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)
• Prior leadership or supervisory experience 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 DHF requirements; ISO 14971 risk management experience preferred
• Proficiency in 3D CAD software (SolidWorks preferred)
• Strong background in electromechanical product design and development; CNC machining and manufacturing process experience 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