Senior Engineer, R&D

Jobtailor

Massachusetts

On-site

USD 120,000 - 160,000

Full time

14 days+

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Job summary

Jobtailor is seeking an experienced Biomedical/Mechanical Engineer to lead life cycle management for sports surgical and shoulder reconstruction products. You will collaborate with cross-functional teams, leverage CAD and prototyping, and ensure regulatory compliance and robust design validation.

You will generate design history files, drawings, and risk documentation while guiding feasibility studies and testing to meet patient needs and manufacturing standards.

Qualifications

Bachelor's degree in mechanical, biomedical, or bioengineering; Master's preferred.
5 years of experience in R&D engineering within the medical device industry; sports medicine preferred.
Strong knowledge of orthopedic biomechanics, anatomy, and physiology, with application to product design.
Proficiency in CAD software (SolidWorks, Pro/ENGINEER) and FEA software.
Familiarity with FDA QSR and ISO 13485 regulatory standards.

Responsibilities

Lead life cycle management of sports surgical and shoulder reconstruction products.
Collaborate with product managers, QA, regulatory, and manufacturing.
Utilize CAD, prototyping, and feasibility studies to craft implant concepts.
Generate and maintain DHF requirements, specifications, drawings, test protocols, and risk documentation.
Design feasibility and verification/validation testing to meet user needs and design requirements.
Provide technical support to manufacturing addressing design issues and process improvements.
Stay updated on industry trends to inform product development strategies and innovation opportunities.

Skills

R&D engineering experience

Cross-functional collaboration

Problem-solving

Strong communication

Education

Bachelor's degree in mechanical engineering

Bachelor's degree in biomedical engineering

Master's degree preferred

Tools

SolidWorks

Pro/ENGINEER

FEA software

Job description

Lead life cycle management activities of sports surgical and shoulder reconstruction products, ensuring alignment to project timelines and regulatory requirements.
Be a critical member of multi-functional teams including product managers, quality assurance, regulatory, and manufacturing.
Leverage CAD software, prototyping techniques, and feasibility studies to craft and iterate on implant and instrument concepts, considering factors such as biomechanics, material properties, and manufacturability.
Generate and maintain detailed design documentation, including design history file requirements, specifications, drawings, test protocols, and risk documentation in compliance with regulatory requirements and internal standards.
Design and conduct feasibility and verification and validation testing to ensure design concepts meet user needs and design requirements.
Provide technical support to manufacturing teams addressing design-related issues and optimizing manufacturing processes.
Stay abreast of industry trends, new technologies, and competitive landscape to advise product development strategies and find opportunities for innovation.

Requirements

A minimum of a Bachelor's degree in mechanical engineering, biomedical engineering, or bioengineering; Master's degree preferred.
5 years of experience in R&D engineering within the medical device industry; experience in sports medicine soft tissue repair preferred.
Strong knowledge of orthopedic biomechanics, anatomy, and physiology, with a demonstrated ability to apply principles to product design and development.
Proficiency in CAD software (e.g., SolidWorks, Pro/ENGINEER) and experience with finite element analysis (FEA) software.
Familiarity with regulatory requirements and standards governing medical device development, including FDA QSR and ISO 13485.
Excellent problem-solving skills and ability to work independently as well as part of a cross-functional team.
Strong communication skills, with the ability to effectively collaborate with internal and external stakeholders.
Passion for innovation and a desire to make a positive impact on patient care.

Core Competencies

Demonstrates expertise in life cycle management of medical devices, particularly in sports surgical and shoulder reconstruction products, with a strong foundation in orthopedic biomechanics and regulatory compliance. Proficient in CAD software and experienced in conducting feasibility studies and validation testing to ensure product efficacy and safety.

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