R&D Engineer

EPM Scientific; Lexington (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

EPM Scientific is seeking an experienced Senior R&D Engineer to drive development and commercialization of innovative medical device products. The role focuses on leading projects from concept through design transfer in a regulated setting, collaborating with cross-functional teams to ensure robust, compliant solutions.

The successful candidate will bring 10–12 years of engineering experience in the medical device industry, with a track record of leading complex projects and delivering design

Qualifications

• 10–12 years of engineering experience in medical devices or other regulated industries.
• Experience leading product development from concept through commercialization.
• Knowledge of design controls, verification & validation, and risk management in regulated environments.
• Strong written and verbal communication; ability to influence cross-functional teams.

Responsibilities

• Lead product development activities across the design and development lifecycle.
• Develop engineering solutions for new products and continuous improvements.
• Generate design concepts, test plans, and technical documentation.
• Collaborate with Quality, Manufacturing, Regulatory, Clinical, and Operations teams.

Skills

Project leadership

Design controls

Regulated environment

Verification & Validation

Cross-functional collaboration

Problem solving

Communication

Education

Mechanical Engineering

Biomedical Engineering

Materials Engineering

Job description

Position Summary

We are seeking an experienced Senior R&D Engineer to support the development and commercialization of innovative medical device products. This individual will play a key role in product development activities from concept through design transfer, collaborating with cross-functional teams to develop robust products and processes that meet customer, business, and regulatory requirements.

The ideal candidate will possess approximately 10-12 years of engineering experience within the medical device industry, with a track record of leading technical projects, solving complex engineering challenges, and supporting product development in a regulated environment.

Key Responsibilities

• Lead product development activities throughout the design and development lifecycle.
• Develop engineering solutions to support new product development and continuous product improvement initiatives.
• Generate design concepts, test plans, technical documentation, and engineering analyses.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, Clinical, and Operations teams to ensure successful project execution.
• Support risk management activities, including design reviews and product risk assessments.
• Plan and execute verification and validation testing to ensure product performance requirements are met.
• Analyze engineering, product, and test data to support design decisions and recommendations.
• Participate in design transfer activities and support manufacturing readiness efforts.Investigate and resolve technical issues through structured problem‑solving methodologies.
• Contribute to project planning, technical decision‑making, and cross‑functional team discussions.
• Ensure compliance with applicable quality systems, design control requirements, and regulatory standards.
• Mentor junior engineers and provide technical guidance across project teams.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related engineering discipline.
• Approximately 10-12 years of engineering experience, preferably within the medical device, biotechnology, or other regulated product industries.
• Experience supporting product development activities from concept through commercialization.
• Knowledge of design control processes, verification and validation, and risk management principles.
• Experience working in a regulated environment governed by FDA, ISO 13485, or similar standards.
• Strong technical problem‑solving, analytical, and troubleshooting skills.
• Demonstrated ability to lead complex projects and influence cross‑functional teams.
• Excellent written, verbal, and interpersonal communication skills.

Preferred Experience

• Class II or Class III medical device development experience.
• Experience with design verification, validation, and statistical data analysis.
• Familiarity with materials, manufacturing processes, or device testing methodologies.
• Participation in design reviews, product risk assessments, and technical documentation development.
• Experience supporting product launches, design transfers, or sustaining engineering initiatives.