Westwood, MA

Job Description: The successful candidate must:

• Contribute technical input during the project planning stage to ensure timelines and resources adequately reflect the engineering complexity of the project.
• As an individual contributor, work to understand complex biological systems, disease pathologies and surgical practices and rapidly generate practical, actionable solutions to problems.
• Use sound analytical practices to collect data and translate that data into objective, informed engineering decisions, design inputs and eventually design outputs.
• Possess a functional knowledge of common design, development and manufacturing tools and methodologies including, but not limited to: machining, injection molding, 3D printing, extrusion, welding of plastics and/or metals, adhesive bonding, etc.
• Have a functional knowledge of design for manufacturing (DFM), including development of test fixtures and production assembly fixtures.
• Have a functional knowledge of medical device design control requirements including risk management, design verification & validation and process validation.
• Possess strong written and verbal communication skills.
• Be able to work independently under general oversight.
• Contribute to the brainstorming process & generate value-added intellectual property.
• Maintain a clean, organized workspace.

Minimum Qualifications:

• 5+ years of experience in medical device prototype and product development within a quality system (21 CFR 820, ISO 13485, etc).
• Proficiency with CAD (SolidWorks preferred), including 2D drawing creation and proper tolerancing practices.
• Experience contributing to design and development programs for medical devices from concept through regulatory submission and commercialization.

Preferred Qualifications:

• Bachelor’s Degree in an engineering discipline (mechanical engineering, biomedical engineering, etc), Master’s Degree preferred.
• Experience in a small, fast-paced startup environment.
• Experience in endoscopic, laparoscopic, or robotic surgical medical device development.
• Experience with gastrointestinal medical device development (upper & lower GI).
• Experience with design & development of implantable medical devices.
• Experience with design and processing of nitinol parts.
• Proficiency with data analysis including statistical methodologies (t-test, f-test, ANOVA, tolerance limit analysis, process capability indices, etc).
• Experience in pre-clinical & clinical study environments .
• Experience with design and processing of medical packaging systems and sterile barriers
• Ability to safely operate a CNC mill & lathe and wire EDM.