Mechanical Engineer

Job Title:

Mechanical Engineer

Job Description

This role focuses on full life cycle new product development for medical devices, from initial concept through commercialization. You will design and develop innovative products, lead design validation and verification activities, and support regulatory submissions with robust technical documentation. The position offers the opportunity to work closely with cross-functional teams, contribute to process and equipment engineering, and help bring novel neurovascular technologies to market.

Responsibilities

+ Lead and support full life cycle new product development from concept through commercialization for medical devices.

+ Perform Solid Works-based mechanical design, including detailed models, drawings, and assemblies.

+ Plan, execute, and document design validation and verification testing to ensure products meet requirements and standards.

+ Develop and validate test methods to support product development, verification, and ongoing product performance assessment.

+ Conduct design analysis and assessment, including product risk assessment, to ensure safety, reliability, and performance.

+ Remediate and update design history and product specifications to align with current requirements and best practices.

+ Prepare and maintain technical documentation such as design history files, drawings, bills of materials, test protocols and reports, and engineering change orders.

+ Assist in the production of engineering reports that provide clear technical explanations to support domestic and international regulatory submissions.

+ Coordinate and lead competitive testing to benchmark products and inform design decisions.

+ Support equipment engineering and process transfer activities to move products from development into manufacturing.

+ Collaborate with Quality and Regulatory teams to prepare products for FDA and other regulatory submissions.

+ Contribute to process development, including validation and verification activities, to ensure robust and repeatable manufacturing processes.

+ Participate in research and development initiatives to explore new concepts, technologies, and product improvements.

+ Work as an effective team player, presenting design concepts, test results, and technical findings to engineering and cross-functional stakeholders.

Essential Skills

+ Bachelor's degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or a related technical field.

+ Demonstrated experience in new product development from concept to commercialization, preferably in medical devices.

+ Proficiency in Solid Works for 3D modeling, design, and drafting.

+

Experience with design validation and verification testing for complex products.

+ expereince in process development, including validation and verification activities.

+

Experience with equipment engineering and process transfer from development to production.

+ Ability to develop and validate test methods for product and process evaluation.

+ Experience in product development engineering within a regulated environment, including familiarity with FDA expectations for medical devices.

+ Strong skills in protocol writing, test documentation, and technical reporting.

+ Ability to remediate and maintain design history files, product specifications, and related technical documentation.

+ Strong analytical and problem-solving abilities for design analysis and product risk assessment.

+ Effective communication and presentation skills, with the ability to work collaboratively as a team player.

+ Adaptability and willingness to work across multiple engineering disciplines and project phases.

Additional

Skills & Qualifications

+ Experience supporting domestic and international regulatory submissions for medical devices.

+ Familiarity with design history files, bills of materials, engineering change orders, and other controlled documentation systems.

+ Exposure to competitive testing and benchmarking of products in a clinical or technical context.

+ Background in neurovascular, cardiovascular, or other interventional medical devices.

+ Interest in continuing education and professional development through mentorship and training opportunities.

+ Comfort working in a setting that offers access and exposure to all levels of engineering and leadership.

Work Environment

This role is based within a global organization that has specialized for over 40 years in the innovation of novel products for the interventional access and treatment of neurovascular diseases. The company offers one of the most comprehensive product portfolios in the field, with products used worldwide to access and treat conditions such as arteriovenous malformations, aneurysms, and ischemic stroke. You will work in a collaborative engineering environment with access and involvement at all levels of the engineering organization, benefiting from a smaller company feel with the support and stability of a larger corporate backing.

The culture emphasizes innovation, growth opportunities…