Principal Medical Device Engineer

Principal Medical Device Engineer

Location: Bedford, MA (Onsite)

Overview

We are seeking an experienced Principal Medical Device Engineer to lead the design, development, and lifecycle management of innovative drug delivery systems and combination products. This role combines technical leadership, hands-on engineering, and strategic product development, supporting projects from concept through commercialization.

The ideal candidate will have extensive experience in medical device development, with a strong preference for injectable and/or ophthalmic combination products.

Key Responsibilities

• Lead the design and development of new and improved medical devices and drug delivery systems.
• Drive product development activities from concept generation through commercialization.
• Plan and oversee design verification, validation, and performance testing activities.
• Conduct research and development efforts focused on innovation and product improvement.
• Provide technical leadership and mentorship to engineering team members.
• Manage project timelines, resources, budgets, and deliverables.
• Support regulatory submissions and responses, including development documentation.
• Research applicable standards, regulations, and clinical use requirements to support product development.
• Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory Affairs, Clinical, Human Factors, and Design Engineering.
• Identify and evaluate new technologies, materials, and manufacturing approaches.
• Analyze testing and manufacturing data to identify trends and opportunities for improvement.
• Lead risk management activities, including product risk assessments and mitigation strategies.
• Develop and implement engineering changes while maintaining compliance with applicable regulations and quality requirements.
• Resolve complex technical challenges related to product design, performance, and manufacturability.

Required Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 15 years of medical device design, development, and testing experience.
• 5 years of experience developing combination products, preferably injectable and/or ophthalmic products.
• Experience supporting all phases of product development from concept through commercialization.
• Strong knowledge of medical device design controls, risk management, and regulatory requirements.
• Experience managing external partners including manufacturers, testing laboratories, and consultants.
• Experience creating, maintaining, and remediating Design History Files (DHFs).
• Knowledge of applicable regulations and standards including Design Controls, Combination Products, ISO 13485, ISO 14971, and Human Factors Engineering requirements.
• Proven experience mentoring engineers and leading multidisciplinary technical teams.
• Experience with project management tools and methodologies.
• Proficiency with CAD software, drafting standards, materials selection, and tolerance analysis.
• Experience developing testing methods, validation strategies, and measurement system analyses.
• Strong understanding of risk management methodologies including FMEA and user risk assessments.
• Experience applying statistical methods in product development and manufacturing environments.
• Excellent leadership, communication, problem-solving, and cross-functional collaboration skills.

Preferred Qualifications

• Experience with injectable drug delivery devices.
• Experience with ophthalmic medical devices or combination products.
• PMP certification.
• Six Sigma Green Belt or equivalent certification.
• Experience developing human factors engineering deliverables and usability studies.
• Experience supporting regulatory submissions and regulatory agency interactions.