Westwood, MA

Overview:

We are seeking a Senior to Principal Engineer to join a growing team of dedicated medical device development professionals working on an innovative, next generation magnetic implant and delivery system. This person is first & foremost an expert in all technical aspects of the design and development of medical devices, with adjacent skills including design controls and some people management. They will join the R&D team and be responsible for the design and execution of mechanical products from concept through commercialization.

Reports to: This position reports to the Director of Engineering

Job Description:

• 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 or leader of a group, 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 in-depth knowledge of a wide array of 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 strong design for manufacturing (DFM) background, including development of test fixtures and production assembly fixtures.
• Have a strong working knowledge of medical device design control requirements including project planning, risk management, design verification & validation and process validation.
• Possess strong written and verbal communication skills.
• Be able to work independently with a wide degree of latitude in day-to-day activities.
• Contribute to the brainstorming process & generate value-added intellectual property.
• Maintain a clean, organized workspace.

Minimum Qualifications:

• 10+ 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 and leading 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.