Job Description

Unique career opportunity for an experienced medical device mechanical engineer with experience in the design of disposables, complex mechanical assemblies and designing for cost reduction.

Our Boston area client is a well-funded startup, developing a clinically significant and market disrupting product for a large, well-established patient population.

The company founders, board and leadership have a record of significant technical and commercial success.

Agile Search is seeking a Senior Mechanical Engineer (design and development) to join this venture.

In this creative, hands-on medical device development role, you will be a key player in a range of product design projects, serving as an integral part of a multi-disciplinary engineering team, and collaborating with external product development firms.

The scope of the position includes design of mechanical subsystems, building prototypes, execution of benchtop evaluations, and complete design verification of the product. Specific tasks include generating engineering documentation such as mechanical drawings, tolerance analyses, verification test protocols and reports, and risk assessments.

You will also work with suppliers to secure components and perform deep analysis on cost of goods.

This is the general role scope, however it's a startup, so there will be so much more!

Qualifications and Industry Experience

• B.S. in Mechanical Engineering, Plastics or preferred; M.S. Engineering preferred
• 5-10 years medical device industry experience designing and developing disposable and/or mechanical components for medical devices
• Working knowledge of medical device design, documentation and regulatory considerations, e.g. sterilization, biocompatibility, reliability, transit, FDA 510(k), IEC60601 and 62366 regulatory compliance and standards
• Successful record designing and prototyping miniature, high tolerance components and complex mechanical subassemblies
• Strong competence analyzing Cost of Goods and working to reduce cost of manufacture for high volume disposables.
• Mastery of CAD to draft detailed engineering drawings
• Experience with mold designs and a variety of manufacturing methods and materials
• Experience in mechanical drug delivery technologies preferred but not required
• Ability to write effective test protocols and reports
• Execution of lab prototype and design verification testing
• Ability to collaborate and communicate with cross-functional teams, including EE and Software Engineers to solve problems and generate new designs and methods
• Knowledge of power systems and electro-mechanical efficiency
• Strong problem-solving and analytical skills, along with strong time management skills, and the ability to generate and track to Gantt charts
• Exceptional written and oral English language proficiency

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