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Medical Device Development Engineer Jobs in Massachusetts

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Medical Device Development Engineer information

What is the difference between Medical Device Development Engineer vs Biomedical Engineer?

AspectMedical Device Development EngineerBiomedical Engineer
CredentialsBachelor's or Master's in Engineering, certifications in medical device regulationsBachelor's or Master's in Biomedical Engineering or related field
Work EnvironmentDesign labs, R&D departments, manufacturing settingsHospitals, research labs, medical device companies
Industry UsageFocuses on designing and developing medical devicesBroader scope including medical equipment, implants, and healthcare technology

Medical Device Development Engineers primarily focus on designing and developing medical devices, working closely with engineering and regulatory teams. Biomedical Engineers have a broader role, often involved in research, testing, and improving medical equipment and healthcare technologies. While both roles require engineering credentials and may work in similar environments, their specific responsibilities and focus areas differ.

What are the key skills and qualifications needed to thrive as a Medical Device Development Engineer, and why are they important?

To thrive as a Medical Device Development Engineer, you need a solid background in biomedical, mechanical, or electrical engineering, often with a relevant degree and experience in product development. Familiarity with CAD software, regulatory standards (like ISO 13485 and FDA requirements), and prototyping tools is typically required. Strong problem-solving abilities, attention to detail, and effective teamwork and communication skills help you excel in multidisciplinary environments. These competencies are vital to ensure medical devices are safe, effective, and compliant with industry regulations.

What does a Medical Device Development Engineer do?

A Medical Device Development Engineer is responsible for designing, developing, and testing medical devices used in healthcare settings. They work closely with doctors, regulatory agencies, and manufacturing teams to ensure devices are safe, effective, and compliant with regulations. Their tasks often include creating prototypes, running experiments, analyzing data, and preparing documentation for regulatory approval. This role requires a strong background in engineering, biology, or materials science, as well as knowledge of medical industry standards.

How do Medical Device Development Engineers typically collaborate with cross-functional teams during the product development process?

Medical Device Development Engineers frequently work alongside professionals from regulatory, quality assurance, manufacturing, and clinical teams to bring products from concept to market. This collaboration ensures that devices are designed for manufacturability, meet regulatory requirements, and address user needs. Regular meetings, design reviews, and documentation exchanges are common, making strong communication and teamwork skills essential for success in the role.
What are popular job titles related to Medical Device Development Engineer jobs in Massachusetts? For Medical Device Development Engineer jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Medical Device Development Engineer jobs in Massachusetts look for? The top searched job categories for Medical Device Development Engineer jobs in Massachusetts are:
Medical Device Development Engineer jobs near you
Infographic showing various Medical Device Development Engineer job openings in Massachusetts as of July 2026, with employment types broken down into 1% As Needed, 80% Full Time, 16% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.
Sr. Engineer, Device Development

Sr. Engineer, Device Development

Ocular Therapeutix

Bedford, MA

Other

Posted 20 days ago

Job description

Position Summary:

This position will serve the role of medical device development engineer within Pharmaceutical Development. Experienced engineer who executes technical development of drug delivery medical devices and packaging.  The role includes but is not limited to determining design input, generating design outputs, conducting design verification and validation, developing manufacturing and inspection processes, supporting GMP manufacturing of clinical trial material. This individual will execute assigned project activities and work with project team members to develop and manufacture the combination products. They may oversee the execution of project tasks and monitor the activities and deliverables of project aspects in a leadership role. The position is set in a dynamic and fast-paced environment.

Critical areas of focus will be mechanical design, testing, risk management activities, technical transfers, scale-up and new process development.

Principal Duties and Responsibilities include the following:

  • Design medical device mechanical components and packaging.
  • Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA)
  • Lead design verification and validation (V&V), design outputs (drawings, specs), and feasibility assessments, including prototyping and lab testing.
  • Collaborate with Quality, Regulatory, Human Factors, and Manufacturing teams, often managing relationships with external CMOs/suppliers.
  • Author technical documentation to ensure compliance with FDA, EU, and ISO standards
  • Communicate project plans, status updates and progress against milestones to project team members including management
  • Generate technical documents including test protocols and reports documenting product and process knowledge
  • Display a strong understanding of product development and transfer needs of commercial development

Qualification Requirements:

  • Minimum of a bachelor's degree (advanced degree desirable) in Mechanical Engineering, Biomedical Engineering or related discipline
  • 8+ years of experience in medical device design, development and testing
  • Strong knowledge and understanding of medical device design controls and product realization processes.
  • Strong knowledge of ISO 13485, ISO 14971, IEC 62366
  • Experience using 3D modeling software such as SolidWorks or ProEngineer
  • Capital project experience, including authoring User Requirement Specifications for processing equipment, vendor proposal selection, design review and Factory Acceptance Testing
  • Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluate processes and develop practical solutions to technical challenges
  • Use of DoE and associated statistical methods for process and design space optimization
  • Demonstrated written and verbal communication skills
  • Demonstrated data analysis and problem-solving skills
  • High degree of initiative and self-motivation to meaningfully advance multiple tasks and projects
  • Strong interpersonal skills
  • Experience solving ambiguous problems
  • Experience creating technical, written content
  • A hard-working, team-player that is passionate about science and can effectively collaborate in a dynamic, cross-functional matrix environment
  • Geometric Dimensioning and Tolerancing (GD&T) practices
  • Ability to interpret and draft technical drawings and schematics
  • Experience designing and developing mechanical assemblies
  • Strong understanding of mechanical engineering principles and methodologies
  • Experience in plastic part design, extrusion techniques and injection molding
  • Familiarity with best practices for implementing automated systems (e.g. GAMP)
  • Drafting of regulatory submission documents and agency audit experience
  1. Working Conditions:
  • Production Floor - gowning requirements
  • Bending
  • Lifting

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