Product Design Development Engineer

Product Designer/Engineer

On-site in Seaport, Massachusetts

Full-Time, Engineer 1, Mid-Level (at least 2-5 years of experience)

AVS is seeking a qualified, hardworking, and independent engineer to design and integrate a controlled electro-mechanical system to operate reliably and safely in a medical environment. The engineer will be an integral part of an R&D team that is developing a new technology for the treatment of heavily calcified arterial vessels.

The engineer will be responsible for developing a range of solutions to mechanical design problems while working closely with groups from different technical and clinical disciplines. Additional responsibilities include:

Responsibilities include:

• Understanding, improving, and meeting user, performance, and functional requirement specifications;
• Envisioning and experiencing the use of the PIVL system in a clinical space and translating feedback from users into the design and functionality of the product;
• Generating detailed 3D representations of systems in CAD including components and assemblies and translating those representations into 2D specifications;
• Designing for the manufacturability and assembly of plastic and metal components including tolerance analysis, material selection, fundamental calculations, and finite element analysis while envisioning and simplifying the manufacturing process
• Selects materials for medical device component parts and assemblies.
• Preparing and presenting technical reports.
• Designing, sourcing, and testing prototypes rapidly to inform the product development lifecycle
• Designing test fixtures, sourcing test equipment and developing procedures for testing products, including acceptance and rejection criteria.
• Conducting design verification to ensure consistency of design outputs against design inputs.
• Contacting and evaluating vendors and/or contractors and managing these relationships during the product lifecycle
• Maintaining design controls, risk management and project management documentation in accordance with established regulatory requirements and SOPs.
• Supporting sustaining and compliance activities.
• Participating in cross-functional development teams that manage projects from concept through commercialization
• Knowing and planning activities consistent with the company’s quality policy and quality objectives

Qualifications

• 2-5yrs of Medical Device design & development experience
• Intimate knowledge with mechanical design and manufacturing processes
• Knowledge of electro-mechanical and pneumatic systems
• Prior experience with designing for manufacturability and industrial design
• 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 and ISO 10993
• 3D solid modelling (e.g., SolidWorks or related software)
• Hands-on experience with machining and 3D prototyping methods preferred
• Good mechanical, analytical & problem-solving skills
• Entrepreneurial attitude, creative with passion for technology, self-starter, strong analytical skills
• Strong communicator: written, verbal (one-on-one and group)
• Committed to high-quality work, open-styled team-player
• Must be eligible to work in the US without sponsorship
• Bachelor of Science in Mechanical, or related discipline.
• Good communication & interpersonal skills